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This study is a randomized, open-label, two periods, cross-over pharmacokinetic, safety, tolerability and relative bioavailability of gepotidacin in healthy adult male and female participants of aged 18 to 50 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants receiving gepotidacin powder for oral suspension followed by tablet | Experimental |
| |
| Participants receiving gepotidacin tablet followed by powder for oral suspension | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gepotidacin | Drug | Gepotidacin will be administered |
|
| Measure | Description | Time Frame |
|---|---|---|
| Periods 1 and 2: Area under the concentration-time curve (AUC) from time zero (pre-dose) extrapolated to infinite time (AUC[0-infinity]) of gepotidacin | Blood samples will be collected for the concentrations of gepotidacin | Up to 48 hours post dose in each period (each period is 3 days) |
| Periods 1 and 2: AUC from time zero to the time of the last quantifiable concentration (AUC[0-t]) of gepotidacin | Blood samples will be collected for the concentrations of gepotidacin | Up to 48 hours post dose in each period (each period is 3 days) |
| Periods 1 and 2: Maximum observed plasma concentration (Cmax) of gepotidacin | Blood samples will be collected for the concentrations of gepotidacin | Up to 48 hours post dose in each period (each period is 3 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Periods 1 and 2: Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 14 days | |
| Periods 1 and 2: Maximum change from Baseline in QT interval corrected with Fridericia's method (QTcF) | Baseline and up to 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Las Vegas | Nevada | 89113 | United States |
IPD for this study will be made available via the Clinical Study Data Request site.
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
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| ID | Term |
|---|---|
| C000612856 | gepotidacin |
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This is a two periods, crossover study
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This is an open-label study
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| Periods 1 and 2: Time to reach maximum observed plasma concentration (Tmax) of gepotidacin | Blood samples will be collected for the concentrations of gepotidacin. | Up to 48 hours post dose in each period (each period is 3 days) |
| Periods 1 and 2: Absorption lag time (Tlag) of gepotidacin | Blood samples will be collected for the concentrations of gepotidacin | Up to 48 hours post dose in each period (each period is 3 days) |
| Periods 1 and 2: Terminal phase half-life (t1/2) of gepotidacin | Blood samples will be collected for the concentrations of gepotidacin | Up to 48 hours post dose in each period (each period is 3 days) |
| Periods 1 and 2: Apparent volume of distribution (Vz/F) of gepotidacin | Blood samples will be collected for the concentrations of gepotidacin | Up to 48 hours post dose in each period (each period is 3 days) |
| Periods 1 and 2: Relative bioavailability (Frel) of gepotidacin | Blood samples will be collected for the concentrations of gepotidacin | Up to 48 hours post dose in each period (each period is 3 days) |
| Periods 1 and 2: Apparent oral clearance (CL/F) of gepotidacin | Blood samples will be collected for the concentrations of gepotidacin | Up to 48 hours post dose in each period (each period is 3 days) |
| Periods 1 and 2: AUC from time zero to 24 hours (AUC[0-24]) of gepotidacin | Urine samples will be collected for the concentrations of gepotidacin. | Up to 24 hours post dose in each period (each period is 3 days) |
| Periods 1 and 2: Total unchanged drug (Ae total) of gepotidacin | Urine samples will be collected for the concentrations of gepotidacin. | Up to 48 hours post dose in each period (each period is 3 days) |
| Periods 1 and 2: Percentage of the given dose of drug excreted in urine (fe%) of gepotidacin | Urine samples will be collected for the concentrations of gepotidacin. | Up to 48 hours post dose in each period (each period is 3 days) |
| Periods 1 and 2: Renal clearance of drug (CLr) of gepotidacin | Urine samples will be collected for the concentrations of gepotidacin. | Up to 48 hours post dose in each period (each period is 3 days) |