NCT05138822

Safety, Tolerability, Pharmacokinetic and Microbiological Investigation of GSK3882347 in Female Participants With Urinary Tract Infections

A Double-Blind, Double Dummy, Randomized, Phase 1b, Nitrofurantoin Controlled, Repeat Oral Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Microbiological Response of GSK3882347 in Female Participants With Acute Uncomplicated Urinary Tract Infection

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Uncomplicated Urinary Tract Infections
• Urinary Tract Infections

Interventions

Type	Name	Description
DRUG	GSK3882347	GSK3882347 was administered.
DRUG	Nitrofurantoin	Nitrofurantoin was administered.
DRUG	Placebo	Placebo matching GSK3882347 or Nitrofurantoin was administered.

Timeline

• Start date: 2022-05-18
• Primary completion: 2024-12-03
• Completion: 2024-12-03
• First posted: 2021-12-01
• Last updated: 2026-03-13
• Results posted: 2026-03-13

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study