Last updated: 01/27/2025 10:50:15
Safety, Tolerability, Pharmacokinetic and Microbiological Investigation of GSK3882347 in Female Participants with Urinary Tract Infections
GSK study ID
212943
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: 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
Trial description: 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 daily 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 purpose:
Treatment
Trial design:
Parallel
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Numbers of participants with microbiological response (responder/non-responder of GSK3882347) at the test of cure (TOC) visit
Timeframe: Day 10 to Day 13
Secondary outcomes:
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Timeframe: Up to Day 31
Number of participants with clinically significant change from baseline in hematology parameters
Timeframe: Baseline (Day 1) and up to Day 31
Number of participants with clinically significant change from baseline in clinical chemistry
Timeframe: Baseline (Day 1) and up to Day 31
Number of participants with clinically significant change from baseline in urinalysis
Timeframe: Baseline (Day 1) and up to Day 31
Number of participants with clinically significant change from baseline in vital signs
Timeframe: Baseline (Day 1) and up to Day 31
Number of participants with clinically significant change from baseline in 12- lead Electrocardiogram (ECG) findings
Timeframe: Baseline (Day 1) and up to Day 31
Plasma concentration of GSK3882347 single dose
Timeframe: Up to Day 5
Urine concentration of GSK3882347 at 22–24-hour (h) interval collection post-dose
Timeframe: Up to Day 5
Interventions:
Enrollment:
140
Primary completion date:
2024-03-12
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Uncomplicated Urinary Tract Infections, Urinary Tract Infections
Product
GSK3882347
Collaborators
Not applicable
Study date(s)
May 2022 to December 2024
Type
Interventional
Phase
1
Participation criteria
Sex
Female
Age
18 - 70 Years
Accepts healthy volunteers
No
- Participants must be greater than or equal to (>=)18 years of age and less than or equal to (<=)70 years
- The participant has 2 or more of the following clinical signs and symptoms of uncomplicated urinary tract infections (uUTI) with onset less than (<) 96 hours of the screening assessment: dysuria, frequency, urgency, or lower abdominal pain
- The participant has a BMI >= 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
Inclusion and exclusion criteria
Inclusion criteria:
- Participants must be greater than or equal to (>=)18 years of age and less than or equal to (<=)70 years
- The participant has 2 or more of the following clinical signs and symptoms of uncomplicated urinary tract infections (uUTI) with onset less than (<) 96 hours of the screening assessment: dysuria, frequency, urgency, or lower abdominal pain
- Participant has nitrite OR pyuria (≥ 10 white blood cells/ cubic millimeter [WBC/mm^3], OR > 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 < 1 percentage (%), during the study intervention period and up to 5 days post intervention
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and protocol.
Exclusion criteria:
- The participant has a BMI >= 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
Trial location(s)
Location
GSK Investigational Site
Miami Lakes, FL, United States, 33016-1507
Status
Study Complete
Showing 1 - 6 of 15 Results
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Study complete
Actual primary completion date
2024-03-12
Actual study completion date
2024-03-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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