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NCT04493931 · ClinicalTrials.gov registry record · Phase 1
Drug-drug Interaction Study of Gepotidacin
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 64
- Enrollment target
NCT04493931: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT04493931 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 64 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04493931, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 64 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric least square (LS) mean and 90 percent (%) confidence interval (CI) of the geometric LS means have been presented.
Interventions
- DRUG Midazolam
- DRUG Digoxin
- DRUG Gepotidacin
- DRUG Rifampicin
- DRUG Cimetidine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2020-08-14 |
| Est. Completion | 2020-12-21 |
| Phase | Phase 1 |
What the finished NCT04493931 record still lists
NCT04493931 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which Midazolam is the first listed.
NCT04493931 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04493931 about?
NCT04493931 is a clinical study titled "Drug-drug Interaction Study of Gepotidacin". 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 i...
What is the current status of trial NCT04493931?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2020-08-14. Estimated completion is 2020-12-21.
What interventions are being tested in trial NCT04493931?
The interventions under investigation include: Midazolam (DRUG), Digoxin (DRUG), Gepotidacin (DRUG), Rifampicin (DRUG), Cimetidine (DRUG).
Who is sponsoring clinical trial NCT04493931?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04493931's enrollment target sits among peer trials
64 808th of 2000 higher than 1,181 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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