Name (Synonyms) | Correlation | |
---|---|---|
drug672 | Cimetidine Wiki | 0.71 |
drug2441 | Reverse-transcription polymerase chain reaction (RT-PCR) Wiki | 0.71 |
drug897 | Digoxin Wiki | 0.71 |
drug649 | Chest computed tomography (CT) Wiki | 0.71 |
drug2445 | Rifampicin Wiki | 0.71 |
drug104 | ASTX660 Wiki | 0.71 |
drug2153 | Placebo matching to gepotidacin Wiki | 0.71 |
drug1179 | Gepotidacin Wiki | 0.71 |
drug1488 | Itraconazole Wiki | 0.50 |
There are 2 clinical trials
In Part 1, the primary objective is to investigate the effect of multiple doses of itraconazole, an inhibitor of CYP3A4, on the pharmacokinetic (PK) profile of a single dose of ASTX660. In Part 2, the primary objective is to investigate the effect of a single dose of ASTX660 on the pharmacokinetics of the CYP3A4 substrate midazolam and its metabolite, 1-hydroxy midazolam. Safety and tolerability of a single dose of ASTX660 in the absence and presence of multiple doses of the CYP3A4 inhibitor itraconazole and in the presence of a single dose of the CYP3A4 substrate midazolam will also be evaluated.
Description: Maximum plasma concentration
Measure: Pharmacokinetic parameter of ASTX660: Cmax Time: From predose up to Day 14Description: Area under the plasma concentration versus time curve from time zero to the last measurable concentration
Measure: Pharmacokinetic parameter of ASTX660: AUC0-t Time: From predose up to Day 14Description: Area under the plasma concentration versus time curve from time zero to 24 hours
Measure: Pharmacokinetic parameter of ASTX660: AUC0-24 Time: From predose up to Day 14Description: Area under the plasma concentration versus time curve from time zero extrapolated to infinity
Measure: Pharmacokinetic parameter of ASTX660: AUC0-inf Time: From predose up to Day 14Description: Maximum plasma concentration
Measure: Pharmacokinetic parameter of midazolam and 1-hydroxyl midazolam: Cmax Time: From predose up to Day 9Description: Area under the plasma concentration versus time curve from time zero to the last measurable concentration
Measure: Pharmacokinetic parameter of midazolam and 1-hydroxyl midazolam: AUC0-t Time: From predose up to Day 9Description: Area under the plasma concentration versus time curve from time zero to 24 hours
Measure: Pharmacokinetic parameter of midazolam and 1-hydroxyl midazolam: AUC0-24 Time: From predose up to Day 9Description: Area under the plasma concentration versus time curve from time zero extrapolated to infinity
Measure: Pharmacokinetic parameter of midazolam and 1-hydroxyl midazolam: AUC0-inf Time: From predose up to Day 9Description: Total apparent clearance
Measure: Pharmacokinetic parameter for ASTX660: CL/F Time: From predose up to Day 14Description: Observed terminal half-life
Measure: Pharmacokinetic parameter for ASTX660: t1/2 Time: From predose up to Day 14Description: Total apparent clearance
Measure: Pharmacokinetic parameter for midazolam: CL/F Time: From predose up to Day 9Description: Observed terminal half-life
Measure: Pharmacokinetic parameter for midazolam: t1/2 Time: From predose up to Day 9This 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 3