Phase 1
N=140
Safety, Tolerability, Pharmacokinetic and Microbiological Investigation of GSK3882347 in Female Participants With Urinary Tract Infections
Uncomplicated Urinary Tract Infections · Urinary Tract Infections
Bottom Line
View on ClinicalTrials.gov: NCT05138822 ↗Enrolled (actual)
140
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Number of Participants With Microbiological Response at the Test of Cure (ToC) Visit — 10; 10; 1; 18 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- GSK3882347 (Drug); Nitrofurantoin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- GlaxoSmithKline
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Microbiological Response at the Test of Cure (ToC) Visit |
10; 10; 1; 18 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) |
10; 22 | — |
| SECONDARY Number of Participants With Serious AEs (SAEs) |
0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Changes in Vital Signs Findings |
0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Changes in Electrocardiograms (ECG) Findings |
0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Changes in Hematology Parameters |
2; 2 | — |
| SECONDARY Number of Participants With Clinically Significant Changes in Chemistry Parameters |
1; 3 | — |
| SECONDARY Number of Participants With Clinically Significant Changes in Urinalysis Parameters |
0; 0 | — |
| SECONDARY Cohort 1: Plasma Concentration at the End of the Dosing Interval Tau (Ctau) of GSK3882347 Post-dose on Day 1 and Day 5 |
— | — |
| SECONDARY Cohort 1: Urine Concentration of GSK3882347 at 22-24-hour (h) Interval Collection Post-dose on Day 1 and Day 5 |
— | — |
| SECONDARY Cohort 2: Plasma Ctau of GSK3882347 Post-dose on Day 1 and Day 5 |
— | — |
| SECONDARY Cohort 2: Urine Concentration of GSK3882347 at 22-24h Interval Collection Post-dose on Day 1 and Day 5 |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- Participants must be greater than or equal to (>=)18 years of age and less than or equal to ( 5 WBC/high power field [HPF]) OR the presence of 2+ leukocyte esterase from a pre-treatment clean-catch midstream urine sample
- Participants with body mass index (BMI) >= 19.0 kilograms per square meter (kg/m^2)
- A female participant is eligible to participate who is not pregnant (as confirmed by a highly sensitive pregnancy test before the first dose of study intervention) or breastfeeding and one of the following conditions apply: 1) Woman participant of non-childbearing potential (WONCBP) Or 2) Woman participant of childbearing potential (WOCBP) using a contraceptive method that is highly effective, with a failure rate of = 40.0 kg/ m^2 or a BMI >=35.0 kg/ m^2 with obesity related health conditions such as high blood pressure or uncontrolled diabetes (non-fasting glucose value >300 milligram/deciliter [mg/dL])
- The participant is immunocompromised or has altered immune defenses that may predispose the participant to a higher risk of treatment failure and/or complications
- The participant has symptoms known or suspected to be caused by another disease process, such as asymptomatic bacteriuria, overactive bladder, chronic incontinence, or chronic interstitial cystitis
- The participant has an anatomical or physiological anomaly that predisposes the participant to UTIs or may be a source of persistent bacterial colonization, including calculi, obstruction of the urinary tract, primary renal disease, or neurogenic bladder, or the participant has a history of anatomical or functional abnormalities of the urinary tract
- The participant has an indwelling catheter, nephrostomy, ureteral stent, or other foreign material in the urinary tract
- The participant who, in the opinion of the investigator, has an otherwise complicated UTI, an active upper UTI (e.g., pyelonephritis, urosepsis), signs and symptoms onset >=96 hours before the screening assessment, or a temperature >=101-degree Fahrenheit (°F) (>=38 degree Celsius [°C]), flank pain, chills, or any other manifestations suggestive of upper UTI
- The participant has anuria, oliguria, or significant impairment of renal function
- The participant presents at enrollment with a suspected sexually transmitted infection
- A positive confirmation of Coronavirus Disease 2019 (COVID-19) infection, or high clinical index of suspicion for COVID-19
- The participant has received treatment with other systemic antimicrobials or systemic antifungals within 1 week or 10 weeks for dalbavancin or oritavancin before study entry.
- Regular alcohol consumption within 6 months prior to the study with an average weekly intake of >14 units for females and one unit is equivalent to approximately 8 g of alcohol: a half-pint (250 mL) of beer, one glass (125 mL) of wine or one (35 mL) measure of spirits
- Unable to take nitrofurantoin. E.g. hypersensitivity to the active substance
Data sourced from ClinicalTrials.gov (NCT05138822). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.