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| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1231 | Digoxin Wiki | 0.71 |
| drug924 | Cimetidine Wiki | 0.71 |
| drug2968 | Placebo matching to gepotidacin Wiki | 0.71 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D001424 | Bacterial Infections NIH | 0.50 |
| D051436 | Renal Insufficiency, Chronic NIH | 0.24 |
| D007674 | Kidney Diseases NIH | 0.19 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0012622 | Chronic kidney disease HPO | 0.24 |
| HP:0000077 | Abnormality of the kidney HPO | 0.19 |
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There are 2 clinical trials
This study is a drug-drug interaction (DDI), pharmacokinetics (PK), safety and tolerability study in adult healthy participants, including Japanese cohort. This study is designed to assess co-administration of probe substrates with gepotidacin in study cohorts 1 to 3 and establishing PK and safety in Japanese participants in cohort 4. Food effect will also be evaluated in cohort 4.
Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 1: Maximum observed concentration (Cmax) of gepotidacin Time: Up to 48 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 1: Time to reach maximum observed plasma concentration (Tmax) of gepotidacin Time: Up to 48 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 1: Terminal phase half-life (t1/2) of gepotidacin Time: Up to 48 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 1: Area under the concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC [0-t]) of gepotidacin Time: Up to 48 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 1: AUC from time 0 (predose) extrapolated to infinite time (AUC[0-infinity]) of gepotidacin Time: Up to 48 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 2: Cmax of gepotidacin Time: Up to 48 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 2: Lag time before observation of drug concentrations (Tlag) of gepotidacin Time: Up to 48 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 2: Tmax of gepotidacin Time: Up to 48 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 2: AUC(0-t) of gepotidacin Time: Up to 48 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 2: AUC(0-infinity) of gepotidacin Time: Up to 48 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of digoxin.
Measure: Cohort 3: Cmax of digoxin Time: Up to 96 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of digoxin.
Measure: Cohort 3: Tlag of digoxin Time: Up to 96 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of digoxin.
Measure: Cohort 3: Tmax of digoxin Time: Up to 96 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of digoxin.
Measure: Cohort 3: AUC(0-t) of digoxin Time: Up to 96 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of digoxin.
Measure: Cohort 3: AUC(0-infinity) of digoxin Time: Up to 96 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of midazolam.
Measure: Cohort 3: Cmax of midazolam Time: Up to 48 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of midazolam.
Measure: Cohort 3: Tlag of midazolam Time: Up to 48 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of midazolam.
Measure: Cohort 3: Tmax of midazolam Time: Up to 48 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of midazolam.
Measure: Cohort 3: AUC(0-t) of midazolam Time: Up to 48 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of midazolam.
Measure: Cohort 3: AUC(0-infinity) of midazolam Time: Up to 48 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: Cmax of gepotidacin after a single 1500 mg dose Time: Up to 48 hours post dose in Period 1 and Period 2Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: Tmax of gepotidacin after a single 1500 mg dose Time: Up to 48 hours post dose in Period 1 and Period 2Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: AUC from time 0 (predose) to 24 hours post dose administration (AUC [0-24]) of gepotidacin after a single 1500 mg dose Time: Up to 24 hours post dose in Period 1 and Period 2Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: AUC from time 0 (predose) to 48 hours post dose administration (AUC [0-48]) of gepotidacin after a single 1500 mg dose Time: Up to 48 hours post dose in Period 1 and Period 2Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: AUC(0-t) of gepotidacin after a single 1500 mg dose Time: Up to 48 hours post dose in Period 1 and Period 2Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: AUC(0-infinity) of gepotidacin after a single 1500 mg dose Time: Up to 48 hours post dose in Period 1 and Period 2Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: Cmax of gepotidacin after the first dose of 3000 mg (morning dose) Time: Up to 60 hours post morning dose in Period 3Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: Tmax of gepotidacin after the first dose of 3000 mg (morning dose) Time: Up to 60 hours post morning dose in Period 3Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: AUC from time 0 (predose) to time tau (AUC[0-tau]) of gepotidacin after the first dose of 3000 mg (morning dose) Time: Up to 60 hours post morning dose in Period 3Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: Cmax of gepotidacin after the second dose of 3000 mg (evening dose) Time: From start of evening dose up to 48 hours post evening dose in Period 3Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: Tmax of gepotidacin after the second dose of 3000 mg gepotidacin (evening dose) Time: From start of evening dose up to 48 hours post evening dose in Period 3Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: AUC(0-tau) of gepotidacin after the second dose of 3000 mg (evening dose) Time: From start of evening dose up to 48 hours post evening dose in Period 3Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: Accumulation ratio for Cmax (RoCmax) of gepotidacin after the second dose of 3000 mg (evening dose) Time: From start of morning dose up to 48 hours post evening dose in Period 3Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: Accumulation ratio for AUC (RoAUC) of gepotidacin after the second dose of 3000 mg (evening dose) Time: From start of morning dose up to 48 hours post evening dose in Period 3Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: AUC(0-24) of gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses Time: From start of morning dose up to 24 hours post morning dose (first dose) in Period 3Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: AUC(0-48) of gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses Time: From start of morning dose up to 48 hours post morning dose (first dose) in Period 3Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: AUC(0-t) of gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses Time: From start of morning dose up to 60 hours post morning dose in Period 3Description: AEs will be collected.
Measure: Cohort 4: Number of participants with non-serious adverse events (non-SAEs) Time: Up to Day 16Description: SAEs will be collected.
Measure: Cohort 4: Number of participants with serious adverse events (SAEs) Time: Up to Day 16Description: Number of participants with abnormal vital signs will be assessed.
Measure: Cohort 4: Number of participants with abnormal vital signs Time: Up to Day 16Description: Single 12-lead ECG will be obtained using an ECG machine. Number of participants with abnormal ECG parameters will be assessed.
Measure: Cohort 4: Number of participants with abnormal electrocardiogram (ECG) findings Time: Up to Day 16Description: Blood samples will be collected for the assessment of hematology parameters.
Measure: Cohort 4: Number of participants with abnormal hematology parameters Time: Up to Day 16Description: Blood samples will be collected for the assessment of chemistry parameters.
Measure: Cohort 4: Number of participants with abnormal clinical chemistry parameters Time: Up to Day 16Description: Urine samples will be collected for the assessment of urinalysis parameters.
Measure: Cohort 4: Number of participants with abnormal urinalysis findings Time: Up to Day 16Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: Cmax of gepotidacin after a single 1500 mg dose under fed conditions Time: Up to 48 hours post dose in Period 1 and Period 2Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: Tlag of gepotidacin after a single 1500 mg dose under fed conditions Time: Up to 48 hours post dose in Period 1 and Period 2Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: Tmax of gepotidacin after a single 1500 mg dose under fed conditions Time: Up to 48 hours post dose in Period 1 and Period 2Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: AUC(0-t) of gepotidacin after a single 1500 mg dose under fed conditions Time: Up to 48 hours post dose in Period 1 and Period 2Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: AUC(0-infinity) of gepotidacin after a single 1500 mg dose under fed conditions Time: Up to 48 hours post dose in Period 1 and Period 2Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 1: AUC(0-24) of gepotidacin Time: Up to 24 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 1: AUC(0-48) of gepotidacin Time: Up to 48 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 1: Tlag of a gepotidacin Time: Up to 48 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 1: Apparent volume of distribution (Vz/F) of gepotidacin Time: Up to 48 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 1: Apparent oral clearance (CL/F) of gepotidacin Time: Up to 48 hours post dose in each periodDescription: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 1: Total unchanged drug (Ae total) of gepotidacin in urine Time: Up to 48 hours post dose in each periodDescription: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 1: AUC(0-24) of gepotidacin in urine Time: Up to 24 hours post dose in each periodDescription: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 1: AUC(0-48) of gepotidacin in urine Time: Up to 48 hours post dose in each periodDescription: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 1: Renal clearance of drug (CLr) of gepotidacin Time: Up to 48 hours post dose in each periodDescription: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 1: Amount of drug excreted in urine in a time interval (Ae[t1-t2]) of gepotidacin Time: Up to 48 hours post dose in each periodDescription: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 1: Percentage of the given dose of drug excreted in urine (fe%) of gepotidacin Time: Up to 48 hours post dose in each periodDescription: AEs will be collected.
Measure: Cohort 1: Number of participants with non-SAEs Time: Up to Day 14Description: SAEs will be collected.
Measure: Cohort 1: Number of participants with SAEs Time: Up to Day 14Description: Blood samples will be collected for the assessment of hematology parameters.
Measure: Cohort 1: Number of participants with abnormal hematology parameters Time: Up to Day 14Description: Blood samples will be collected for the assessment of chemistry parameters.
Measure: Cohort 1: Number of participants with abnormal clinical chemistry parameters Time: Up to Day 14Description: Urine samples will be collected for the assessment of urinalysis parameters.
Measure: Cohort 1: Number of participants with abnormal urinalysis findings Time: Up to Day 14Description: Number of participants with abnormal vital signs will be assessed.
Measure: Cohort 1: Number of participants with abnormal vital signs Time: Up to Day 14Description: Single 12-lead ECG will be obtained using an ECG machine. Number of participants with abnormal ECG parameters will be assessed.
Measure: Cohort 1: Number of participants with abnormal ECG findings Time: Up to Day 14Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 2: AUC(0-24) of gepotidacin Time: Up to 24 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 2: AUC(0-48) of gepotidacin Time: Up to 48 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 2: T1/2 of a gepotidacin Time: Up to 48 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 2: Vz/F of gepotidacin Time: Up to 48 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 2: CL/F of gepotidacin Time: Up to 48 hours post dose in each periodDescription: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 2: Ae total of gepotidacin in urine Time: Up to 48 hours post dose in each periodDescription: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 2: AUC(0-24) of gepotidacin in urine Time: Up to 24 hours post dose in each periodDescription: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 2: AUC(0-48) of gepotidacin in urine Time: Up to 48 hours post dose in each periodDescription: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 2: CLr of gepotidacin in urine Time: Up to 48 hours post dose in each periodDescription: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 2: Ae(t1-t2) of gepotidacin in urine Time: Up to 48 hours post dose in each periodDescription: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 2: fe% of gepotidacin in urine Time: Up to 48 hours post dose in each periodDescription: AEs will be collected.
Measure: Cohort 2: Number of participants with non-SAEs Time: Up to Day 20Description: SAEs will be collected.
Measure: Cohort 2: Number of participants with SAEs Time: Up to Day 20Description: Blood samples will be collected for the assessment of hematology parameters.
Measure: Cohort 2: Number of participants with abnormal hematology parameters Time: Up to Day 20Description: Blood samples will be collected for the assessment of chemistry parameters.
Measure: Cohort 2: Number of participants with abnormal clinical chemistry parameters Time: Up to Day 20Description: Urine samples will be collected for the assessment of urinalysis parameters.
Measure: Cohort 2: Number of participants with abnormal urinalysis findings Time: Up to Day 20Description: Number of participants with abnormal vital signs will be assessed.
Measure: Cohort 2: Number of participants with abnormal vital signs Time: Up to Day 20Description: Single 12-lead ECG will be obtained using an ECG machine. Number of participants with abnormal ECG parameters will be assessed.
Measure: Cohort 2: Number of participants with abnormal ECG findings Time: Up to Day 20Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 3: Cmax of gepotidacin after the first dose of 3000 mg (morning dose) Time: Up to 60 hours post morning dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 3: Tmax of gepotidacin after the first dose of 3000 mg (morning dose) Time: Up to 60 hours post morning dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 3: Tlag of gepotidacin after the first dose of 3000 mg (morning dose) Time: Up to 60 hours post morning dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 3: AUC(0-tau) of gepotidacin first dose of 3000 mg (morning dose) Time: Up to 60 hours post morning dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 3: Cmax of gepotidacin after the second dose of 3000 mg (evening dose) Time: From start of evening dose up to 48 hours post evening dose in each PeriodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 3: Tmax of gepotidacin after the second dose of 3000 mg (evening dose) Time: From start of evening dose up to 48 hours post evening dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 3: RoCmax of gepotidacin after the second dose of 3000 mg (evening dose) Time: From start of morning dose up to 48 hours post evening dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 3: RoAUC of gepotidacin after the second dose of 3000 mg (evening dose) Time: From start of morning dose up to 48 hours post evening dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 3: AUC(0-tau) of gepotidacin after the second dose of 3000 mg (evening dose) Time: From start of evening dose up to 48 hours post evening dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 3: AUC(0-24) of gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses Time: From start of morning dose up to 24 hours post morning dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 3: AUC(0-48) of gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses Time: From start of morning dose up to 48 hours post morning dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 3: AUC(0-t) of gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses Time: From start of morning dose up to 60 hours post morning dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 3: Vz/Fof gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses Time: From start of morning dose up to 60 hours post morning dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 3: CL/F of gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses Time: From start of morning dose up to 60 hours post morning dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 3: T1/2 of gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses Time: From start of morning dose up to 60 hours post morning dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of digoxin.
Measure: Cohort 3: Trough concentration (Cmin) of digoxin Time: Up to 96 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of digoxin.
Measure: Cohort 3: t1/2 of digoxin Time: Up to 96 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of digoxin.
Measure: Cohort 3: Vz/F of digoxin Time: Up to 96 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of digoxin.
Measure: Cohort 3: CL/F of digoxin Time: Up to 96 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of midazolam.
Measure: Cohort 3: Cmin of midazolam Time: Up to 48 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of midazolam.
Measure: Cohort 3: t1/2 of midazolam Time: Up to 48 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of midazolam.
Measure: Cohort 3: Vz/F of midazolam Time: Up to 48 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of midazolam.
Measure: Cohort 3: CL/F of midazolam Time: Up to 48 hours post dose in each periodDescription: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 3: Ae total of gepotidacin in urine following two 3000 mg doses Time: From start of morning dose up to 60 hours post morning dose in each periodDescription: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 3: Ae(t1-t2) of gepotidacin in urine following two 3000 mg doses Time: From start of morning dose up to 60 hours post morning dose in each periodDescription: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 3: AUC(0-tau) of gepotidacin in urine following two 3000 mg doses Time: From start of morning dose up to 60 hours post morning dose in each periodDescription: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 3: AUC(0-24) of gepotidacin in urine following two 3000 mg doses Time: From start of morning dose up to 24 hours post morning dose in each periodDescription: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 3: AUC(0-48) of gepotidacin in urine following two 3000 mg doses (urine) Time: From start of morning dose up to 48 hours post morning dose in each periodDescription: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 3: fe% of gepotidacin in urine following two 3000 mg doses Time: From start of morning dose up to 48 hours post morning dose in each periodDescription: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 3: CLr of gepotidacin in urine following two 3000 mg doses Time: From start of morning dose up to 60 hours post morning dose in each periodDescription: AEs will be collected.
Measure: Cohort 3: Number of participants with non-SAEs Time: Up to Day 30Description: SAEs will be collected.
Measure: Cohort 3: Number of participants with SAEs Time: Up to Day 30Description: Blood samples will be collected for the assessment of hematology parameters.
Measure: Cohort 3: Number of participants with abnormal hematology parameters Time: Up to Day 30Description: Blood samples will be collected for the assessment of chemistry parameters.
Measure: Cohort 3: Number of participants with abnormal clinical chemistry parameters Time: Up to Day 30Description: Urine samples will be collected for the assessment of urinalysis parameters.
Measure: Cohort 3: Number of participants with abnormal urinalysis Time: Up to Day 30Description: Number of participants with abnormal vital signs will be assessed.
Measure: Cohort 3: Number of participants with abnormal vital signs Time: Up to Day 30Description: Single 12-lead ECG will be obtained using an ECG machine. Number of participants with abnormal ECG findings will be assessed.
Measure: Cohort 3: Number of participants with abnormal ECG findings Time: Up to Day 30Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: T1/2 of gepotidacin after a single 1500 mg dose Time: Up to 48 hours post dose in Period 1 and Period 2Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: Vz/F of gepotidacin after a single 1500 mg dose Time: Up to 48 hours post dose in Period 1 and Period 2Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: CL/F of gepotidacin after a single 1500 mg dose Time: Up to 48 hours post dose in Period 1 and Period 2Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: Tlag of gepotidacin after the first dose of 3000 mg (morning dose) Time: Up to 60 hours post morning dose in Period 3Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: Vz/F of gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses Time: From start of morning dose up to 60 hours post morning dose in Period 3Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: CL/F of gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses Time: From start of morning dose up to 60 hours post morning dose in Period 3Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: t1/2 of gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses Time: From start of morning dose up to 60 hours post morning dose in Period 3Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: Ae total of gepotidacin in urine after a single 1500 mg dose Time: Up to 48 hours post dose in Period 1 and Period 2Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: Ae(t1-t2) of gepotidacin in urine after a single 1500 mg dose Time: Up to 48 hours post dose in Period 1 and Period 2Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: AUC(0-tau) of gepotidacin in urine after a single 1500 mg dose Time: Up to 48 hours post dose in Period 1 and Period 2Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: AUC(0-24) of gepotidacin in urine after a single 1500 mg dose Time: Up to 24 hours post dose in Period 1 and Period 2Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: AUC(0-48) of gepotidacin in urine after a single 1500 mg dose Time: Up to 48 hours post dose in Period 1 and Period 2Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: fe% of gepotidacin in urine after a single 1500 mg dose Time: Up to 48 hours post dose in Period 1 and Period 2Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: CLr of gepotidacin in urine after a single 1500 mg dose Time: Up to 48 hours post dose in Period 1 and Period 2Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: Ae total of gepotidacin in urine following two 3000 mg doses Time: From start of morning dose up to 60 hours post morning dose in Period 3Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: Ae(t1-t2) of gepotidacin in urine following two 3000 mg doses Time: From start of morning dose up to 60 hours post morning dose in Period 3Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: AUC(0-tau) of gepotidacin in urine following two 3000 mg doses Time: From start of morning dose up to 60 hours post morning dose in Period 3Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: AUC(0-24) of gepotidacin in urine following two 3000 mg doses Time: From start of morning dose up to 24 hours post morning dose in Period 3Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: AUC(0-48) of gepotidacin in urine following two 3000 mg doses Time: From start of morning dose up to 48 hours post morning dose in Period 3Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: fe% of gepotidacin in urine following two 3000 mg doses Time: From start of morning dose up to 60 hours post morning dose in Period 3Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: CLr of gepotidacin in urine following two 3000 mg doses Time: From start of morning dose up to 60 hours post morning dose in Period 3This Phase 1 study aims to quantify the effects of cyclosporine, a broad transporter inhibitor, and rifampicin, an OATP1B1/3 inhibitor, on verinurad pharmacokinetics (PK). The study is conducted in accordance with Food and Drug Administration guidance on Clinical Drug Interaction Studies, 2020. Verinurad will be developed as a fixed combination since it will always be administered together with allopurinol.
Description: Verinurad Cmax ratio of geometric mean of test treatment (verinurad+allopurinol with (cyclosporine or rifampicin), relative to reference treatment (verinurad+allopurinol alone) in each treatment period
Measure: Geometric mean ratio of maximum observed plasma peak concentration (Cmax) for verinurad Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: Verinurad AUCinf ratio of geometric means of test treatment, relative to reference treatment in each treatment period
Measure: Geometric mean ratio of area under plasma concentration-time curve from time zero to infinity (AUCinf) for verinurad Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: Verinurad AUClast ratio of geometric means of test treatment, relative to reference treatment in each treatment period
Measure: Geometric mean ratio of area under the plasma concentration-time curve from zero to time of last quantifiable concentration (AUClast) for verinurad Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: Cmax ratio of geometric means of test treatment, relative to reference treatment in each treatment period
Measure: Geometric mean ratio of Cmax for verinurad metabolite: M1 Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: Cmax ratio of geometric means of test treatment, relative to reference treatment in each treatment period
Measure: Geometric mean ratio of Cmax for verinurad metabolite: M8 Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: AUCinf ratio of geometric means of test treatment, relative to reference treatment in each treatment period
Measure: Geometric mean ratio of AUCinf for verinurad metabolite: M1 Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: AUCinf ratio of geometric means of test treatment, relative to reference treatment in each treatment period
Measure: Geometric mean ratio of AUCinf for verinurad metabolite: M8 Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: AUClast ratio of geometric means of test treatment, relative to reference treatment in each treatment period
Measure: Geometric mean ratio of AUClast for verinurad metabolite: M1 Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: AUClast ratio of geometric means of test treatment, relative to reference treatment in each treatment period
Measure: Geometric mean ratio of AUClast for verinurad metabolite: M8 Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: Allopurinol Cmax ratio of geometric means of test treatment, relative to reference treatment in each treatment period
Measure: Geometric mean ratio of Cmax for allopurinol Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: Allopurinol AUCinf ratio of geometric means of test treatment, relative to reference treatment in each treatment period
Measure: Geometric mean ratio of AUCinf for allopurinol Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: Allopurinol AUClast ratio of geometric means of test treatment, relative to reference treatment in each treatment period
Measure: Geometric mean ratio of AUClast for allopurinol Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: Oxypurinol Cmax ratio of geometric means of test treatment, relative to reference treatment in each treatment period
Measure: Geometric mean ratio of Cmax for oxypurinol Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: Oxypurinol AUCinf ratio of geometric means of test treatment, relative to reference treatment in each treatment period
Measure: Geometric mean ratio of AUCinf for oxypurinol Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: Oxypurinol AUClast ratio of geometric means of test treatment, relative to reference treatment in each treatment period
Measure: Geometric mean ratio of AUClast for oxypurinol Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: Cmax of verinurad, M1, M8, allopurinol and oxypurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period
Measure: Cmax Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: AUCinf of verinurad, M1, M8, allopurinol and oxypurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period
Measure: AUCinf Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: AUClast of verinurad, M1, M8, allopurinol and oxypurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period
Measure: AUClast Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: AUC(0-24) of verinurad, M1, M8, allopurinol and oxypurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period
Measure: Area under the concentration-time curve from time zero to 24 hours post-dose [AUC(0-24)] Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: tmax of verinurad, M1, M8, allopurinol and oxypurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period
Measure: Time to reach peak or maximum observed concentration following drug (tmax) Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: t½λz of verinurad, M1, M8, allopurinol and oxypurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period
Measure: Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t½λz) Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: λz of verinurad, M1, M8, allopurinol and oxypurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period
Measure: Terminal elimination rate constant (λz) Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: CL/F of verinurad and allopurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period
Measure: Apparent total body clearance of drug from plasma after extravascular administration (CL/F) Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: MRTinf of verinurad and allopurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period
Measure: Mean Residence Time of the unchanged drug in the systemic circulation (MRTinf) Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: Vss/F of verinurad and allopurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period
Measure: Volume of distribution (apparent) at steady state following extravascular administration (Vss/F) Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: Vz/F of verinurad and allopurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period
Measure: Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F) Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: MP ratio of Cmax for verinurad when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period
Measure: Metabolite:Parent (MP) ratio of Cmax Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: MP ratio of AUCinf for verinurad when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period
Measure: MP ratio of AUCinf Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: MP ratio of AUClast for verinurad when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period
Measure: MP ratio of AUClast Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: Observed values and change from baseline value in systolic and diastolic BP for subjects administered with verinurad and allopurinol in combination with cyclosporine or rifampicin
Measure: Number of subjects with abnormal blood pressure (BP) Time: For approximately 9 weeks (from screening to follow-up)Description: Observed values and change from baseline value in pulse rate for subjects administered with verinurad and allopurinol in combination with cyclosporine or rifampicin
Measure: Number of subjects with abnormal pulse rate Time: For approximately 9 weeks (from screening to follow-up)Description: Observed values and change from baseline value in temperature for subjects administered with verinurad and allopurinol in combination with cyclosporine or rifampicin
Measure: Number of subjects with abnormal temperature Time: For approximately 9 weeks (from screening to follow-up)Description: 12-lead resting ECG safety assessments if there are any abnormal findings for subjects administered with verinurad and allopurinol in combination with cyclosporine or rifampicin
Measure: Number of subjects with abnormal 12-lead electrocardiogram (ECG) Time: At screening and post-treatment follow-up visit (7-14 day after last dose of verinurad)Description: Any new or aggravated clinically relevant abnormal medical physical examination finding compared to the baseline assessment for subjects administered with verinurad and allopurinol in combination with cyclosporine or rifampicin
Measure: Number of subjects with abnormal physical examination Time: For approximately 9 weeks (from screening to follow-up)Description: Observed values and change from baseline value in hematology parameters for subjects administered with verinurad and allopurinol in combination with cyclosporine or rifampicin
Measure: Number of subjects with abnormal hematology parameters Time: At screening, Day -1, Day 3 (Treatment Periods 1, 2 and 3) and post-treatment follow-up (7-14 days after last dose of verinurad)Description: Observed values and change from baseline value in clinical chemistry parameters for subjects administered with verinurad and allopurinol in combination with cyclosporine or rifampicin
Measure: Number of subjects with abnormal clinical chemistry parameters Time: At screening, Day -1 (Treatment Periods 1 and 3), Day 1, Day 2 and Day 3 (Treament Period 1), and post-treatment follow-up (7-14 days after last dose of verinurad)Description: Observed values and change from baseline value in urinalysis parameters for subjects administered with verinurad and allopurinol in combination with cyclosporine or rifampicin
Measure: Number of subjects with abnormal urinalysis parameters Time: At screening, Day -1 (Treatment Periods 1 and 3), Day 1, Day 2 and Day 3 (Treament Period 1), and post-treatment follow-up (7-14 days after last dose of verinurad)Description: The number and percentage of subjects with AEs and the number of events for subjects administered with verinurad and allopurinol in combination with cyclosporine or rifampicin
Measure: Number of subjects with adverse events (AEs) and serious AEs Time: For approximately 9 weeks (from screening to follow-up)Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports