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| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1231 | Digoxin Wiki | 0.45 |
| drug446 | BAY2328065 tablet Wiki | 0.45 |
| drug4770 | telehealth applications Wiki | 0.45 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug683 | CBD Isolate Wiki | 0.45 |
| drug924 | Cimetidine Wiki | 0.45 |
| drug142 | ASTX660 Wiki | 0.45 |
| drug1581 | Full Spectrum CBD Oil Wiki | 0.45 |
| drug2968 | Placebo matching to gepotidacin Wiki | 0.45 |
| drug445 | BAY2328065 LSF Wiki | 0.45 |
| drug1637 | Gepotidacin Wiki | 0.45 |
| drug2944 | Placebo LSF Wiki | 0.45 |
| drug2986 | Placebo tablet Wiki | 0.45 |
| drug789 | COVIDSeq Test Wiki | 0.45 |
| drug2946 | Placebo Oil Wiki | 0.45 |
| drug3363 | Rifampicin Wiki | 0.32 |
| drug465 | BI 474121 Wiki | 0.32 |
| drug4266 | Vonoprazan Wiki | 0.32 |
| drug3942 | Telmisartan Wiki | 0.26 |
| drug2028 | Itraconazole Wiki | 0.26 |
| drug2916 | Placebo Wiki | 0.02 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D015775 | Fractures, Stress NIH | 0.32 |
| D001424 | Bacterial Infections NIH | 0.32 |
| D004715 | Endometriosis NIH | 0.22 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D020920 | Dyssomnias NIH | 0.18 |
| D020447 | Parasomnias NIH | 0.17 |
| D000437 | Alcoholism NIH | 0.17 |
| D011665 | Pulmonary Valve Insufficiency NIH | 0.15 |
| D019966 | Substance-Related Disorders NIH | 0.12 |
| D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.04 |
| D055371 | Acute Lung Injury NIH | 0.04 |
| D012128 | Respiratory Distress Syndrome, Adult NIH | 0.03 |
| D003141 | Communicable Diseases NIH | 0.03 |
| D007239 | Infection NIH | 0.02 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.02 |
| D018352 | Coronavirus Infections NIH | 0.02 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0030127 | Endometriosis HPO | 0.22 |
| HP:0010444 | Pulmonary insufficiency HPO | 0.15 |
Navigate: Correlations HPO
There are 5 clinical trials
Study on the safety and tolerability of a new drug BAY2328065 when given increased doses as tablet or solution over 12 days to healthy male participants. Researcher want to study how the body absorbs, breaks down and excrete the new drug, also when given together with a test meal. In addition the study will investigate changes that take place in the body when BAY2328065 is given together with another drug.
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 3The main objectives of this trial are to investigate safety and tolerability of BI 474121 in healthy male and female young and elderly subjects following oral administration of multiple rising doses per day over 14 days.
Description: After the first dose of BI 474121
Measure: Area under the concentration-time curve of the analyte in plasma from 0 to 24h (AUC0-24) Time: Up to Day 1Description: After the first dose of BI 474121
Measure: Maximum measured concentration of the analyte in plasma (Cmax) Time: Up to Day 1Description: After the last dose of BI 474121
Measure: Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss) Time: Up to Day 14Description: After the last dose of BI 474121
Measure: Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss) Time: Up to Day 14Description: After each of three doses Midazolam
Measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) Time: Up to Day 14Description: After each of three doses Midazolam
Measure: Maximum measured concentration of the analyte in plasma (Cmax) Time: Up to Day 14To determine the time-dependent inhibition potential of repeated doses of oral vonoprazan on the pharmacokinetics (PK) of a single oral dose of midazolam, a sensitive cytochrome P450 3A4 (CYP3A4) substrate, in healthy participants.
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.
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