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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.

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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

FieldValue
Enrollment Target 64 participants
Start Date 2020-08-14
Est. Completion 2020-12-21
Phase Phase 1

Sponsor

GlaxoSmithKline

1,345 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.