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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: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT05138822 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 140 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (133% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Microbiological response (success/failure) is used to measure microbiological efficacy. Microbiological success was defined as a reduction in E. coli count to less than (\<) 10\^3 colony-forming units (CFU) per milliliter (CFU/mL) for any E. coli at the ToC visit. Microbiological failure included all other microbiological outcomes (for example but not limited to \>=10\^3 CFU/mL for any E. coli identified at ToC visit, use of rescue medication prior to ToC, lost to follow-up before ToC, missing/u
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 |
What the finished NCT05138822 record still lists
NCT05138822 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (133% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT05138822 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05138822's enrollment target sits among peer trials
140 402nd of 2000 higher than 1,583 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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