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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 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 64 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04493931
The ClinicalTrials.gov registry entry for NCT04493931 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Midazolam is the first listed.
NCT04493931 reports 0 study locations.
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.
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