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NCT05138822 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, Pharmacokinetic and Microbiological Investigation of GSK3882347 in Female Participants With Urinary Tract Infections
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 140
- Enrollment target
NCT05138822 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 140 participants.
The verdict
NCT05138822, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 140 participants
- Enrollment target
Study Summary
This phase 1b study is a double-blind, double-dummy, nitrofurantoin-controlled study designed to evaluate microbiological response at the test of cure (ToC) visit along with safety, tolerability and pharmacokinetic (PK) response following oral dosing for 5 days of GSK3882347 in an adult female with uncomplicated urinary tract infections (uUTI). Comparator nitrofurantoin will be included in the study to ensure unbiased reporting of safety events. The study will be separated into 2 cohorts. Cohort 1 consists of an inpatient treatment period and PK analysis at frequent timepoints. Cohort 2 includes an outpatient treatment period and PK analysis conducted less frequently, at key trough timepoints.
Interventions
- DRUG Placebo
- DRUG Nitrofurantoin
- DRUG GSK3882347
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2022-05-18 |
| Est. Completion | 2024-12-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05138822
The ClinicalTrials.gov registry entry for NCT05138822 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 140 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 3 interventions - of which Placebo is the first listed.
NCT05138822 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05138822 about?
NCT05138822 is a clinical study titled "Safety, Tolerability, Pharmacokinetic and Microbiological Investigation of GSK3882347 in Female Participants With Urinary Tract Infections". This phase 1b study is a double-blind, double-dummy, nitrofurantoin-controlled study designed to evaluate microbiological response at the test of cure (ToC) visit along with safety, tolerability and pharmacokinetic (PK) response following oral dosing for 5 days of GSK3882347 in an adult female with ...
What is the current status of trial NCT05138822?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 140 participants. The study started on 2022-05-18. Estimated completion is 2024-12-03.
What interventions are being tested in trial NCT05138822?
The interventions under investigation include: Placebo (DRUG), Nitrofurantoin (DRUG), GSK3882347 (DRUG).
Who is sponsoring clinical trial NCT05138822?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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