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NCT04079790 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics of Gepotidacin Tablets in Adults and Adolescents Subjects
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
NCT04079790 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 34 participants.
The verdict
NCT04079790, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
Study Summary
This is double-blind, randomized, sequential, two part study. Part 1 is a 3 periods, fixed-sequence study and will be conducted to evaluate the pharmacokinetics, safety, and tolerability of the gepotidacin tablet in healthy adult subjects. Part 2 is a 2 periods, fixed-sequence study and will evaluate the pharmacokinetics, safety, and tolerability of the gepotidacin tablet in healthy adolescent subjects. The primary purpose of Part 1 is to evaluate the pharmacokinetics of a single 1500 milligram (mg) dose and two 3000 mg doses of gepotidacin given 6 and 12 hours apart in adult subjects; Part 2 is to evaluate the pharmacokinetics of a single 1500 mg dose and two 3000 mg doses of gepotidacin given at a dosing interval (to be determined based on the pharmacokinetic and safety results from Part 1) in adolescent subjects. The duration of Part A will be approximately 47 days and 52 days for Part 2.
Interventions
- DRUG Placebo
- DRUG Gepotidacin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2019-09-04 |
| Est. Completion | 2019-11-25 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04079790
The ClinicalTrials.gov registry entry for NCT04079790 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 34 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 2 interventions - of which Placebo is the first listed.
NCT04079790 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04079790 about?
NCT04079790 is a clinical study titled "Pharmacokinetics of Gepotidacin Tablets in Adults and Adolescents Subjects". This is double-blind, randomized, sequential, two part study. Part 1 is a 3 periods, fixed-sequence study and will be conducted to evaluate the pharmacokinetics, safety, and tolerability of the gepotidacin tablet in healthy adult subjects. Part 2 is a 2 periods, fixed-sequence study and will evaluat...
What is the current status of trial NCT04079790?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2019-09-04. Estimated completion is 2019-11-25.
What interventions are being tested in trial NCT04079790?
The interventions under investigation include: Placebo (DRUG), Gepotidacin (DRUG).
Who is sponsoring clinical trial NCT04079790?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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