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NCT03568942 · ClinicalTrials.gov registry record · Phase 2

Pharmacokinetic Study of Oral Gepotidacin (GSK2140944) in Subjects With Uncomplicated Urinary Tract Infection (Acute Cystitis)

A Phase 2 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 2
Development phase
22
Enrollment target

NCT03568942 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 22 participants.

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The verdict

NCT03568942, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 2
Development phase
22 participants
Enrollment target

Study Summary

Gepotidacin (GSK2140944) is a novel triazaacenaphthylene bacterial type II topoisomerase inhibitor that is being developed for the treatment of uncomplicated urinary tract infections (UTIs; acute cystitis). This Phase IIa study will evaluate plasma and urine pharmacokinetics of gepotidacin in female subjects with acute cystitis. Eligible female subjects will receive twice daily (BID) dose of gepotidacin 1500 milligram (mg) for 5 days via oral route. Pre-treatment and post-treatment samples for pharmacokinetic (PK) assessments will be collected throughout the study. The total duration of the study is approximately 28 days.

Interventions

  • DRUG Gepotidacin

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2018-07-23
Est. Completion 2019-01-07
Phase Phase 2

Sponsor

GlaxoSmithKline

1,345 total trials

What the Registry Record Tells You About NCT03568942

The ClinicalTrials.gov registry entry for NCT03568942 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 22 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 1 intervention - of which Gepotidacin is the first listed.

NCT03568942 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03568942 about?

NCT03568942 is a clinical study titled "Pharmacokinetic Study of Oral Gepotidacin (GSK2140944) in Subjects With Uncomplicated Urinary Tract Infection (Acute Cystitis)". Gepotidacin (GSK2140944) is a novel triazaacenaphthylene bacterial type II topoisomerase inhibitor that is being developed for the treatment of uncomplicated urinary tract infections (UTIs; acute cystitis). This Phase IIa study will evaluate plasma and urine pharmacokinetics of gepotidacin in female...

What is the current status of trial NCT03568942?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2018-07-23. Estimated completion is 2019-01-07.

What interventions are being tested in trial NCT03568942?

The interventions under investigation include: Gepotidacin (DRUG).

Who is sponsoring clinical trial NCT03568942?

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.