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

Recruitment & Eligibility

Status: Recruiting

Sex: Female

Target Recruitment: Not specified

Inclusion 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

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Numbers of participants with microbiological response (responder/non-responder of GSK3882347) at the test of cure (TOC) visit

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse events (AEs) and serious adverse events (SAEs);Number of participants with clinically significant change from baseline in hematology parameters;Number of participants with clinically significant change from baseline in clinical chemistry;Number of participants with clinically significant change from baseline in urinalysis;Number of participants with clinically significant change from baseline in vital signs;Number of participants with clinically significant change from baseline in 12- lead Electrocardiogram (ECG) findings;Plasma concentration of GSK3882347 single dose;Urine concentration of GSK3882347 at 22-24-hour (h) interval collection post-dose

Related Trials

Monoclonal Antibody Therapy against Chronic Herpes Simplex Virus 2 infectio

Phase 1

Heidelberg ImmunoTherapeutics GmbH

Updated 11/22/2021

A Randomised, Phase II, Double-Blind, Double-Dummy, four-period Crossover Efficacy and Safety Comparison of 4-Week Treatment Periods of Blinded Fluticasone (500 µg bid, MDI), Ciclesonide (400 µg qd, MDI), Ciclesonide (800 µg qd, MDI) or placebo in Free Combination with Open-Label Tiotropium (18 µg qd, HandiHaler®) and Salmeterol (50 µg bid, Diskus®) in Patients with COPD. - Triple Combo

Phase 1

Boehringer Ingelheim bv

Updated 4/4/2022

A Randomised, Phase II, Double-Blind, Double-Dummy, four-period Crossover Efficacy and Safety Comparison of 4-Week Treatment Periods of Blinded Fluticasone (500 µg bid, MDI), Ciclesonide (400 µg qd, MDI), Ciclesonide (800 µg qd, MDI) or placebo in Free Combination with Open-Label Tiotropium (18 µg qd, HandiHaler®) and Salmeterol (50 µg bid, Diskus®) in Patients with COPD.

Boehringer Ingelheim Pharma GmbH & Co. KG

Updated 3/19/2012

A Randomised, Phase II, Double-Blind, Double-Dummy, four-period Crossover Efficacy and Safety Comparison of 4-Week Treatment Periods of Blinded Fluticasone (500 µg bid, MDI), Ciclesonide (400 µg qd, MDI), Ciclesonide (800 µg qd, MDI) or placebo in Free Combination with Open-Label Tiotropium (18 µg qd, HandiHaler®) and Salmeterol (50 µg bid, Diskus®) in Patients with COPD.

Boehringer Ingelheim Denmark

Updated 3/19/2012

A Randomised, Phase II, Double-Blind, Double-Dummy, four-period Crossover Efficacy and Safety Comparison of 4-Week Treatment Periods of Blinded Fluticasone (500 µg bid, MDI), Ciclesonide (400 µg qd, MDI), Ciclesonide (800 µg qd, MDI) or placebo in Free Combination with Open-Label Tiotropium (18 µg qd, HandiHaler®) and Salmeterol (50 µg bid, Diskus®) in Patients with COPD.

SCS Boehringer Ingelheim Comm.V

Updated 10/7/2014

Study Evaluating the Safety and Efficacy of Semaglutide, and the Fixed-Dose Combination of Cilofexor and Firsocostat, Alone and in Combination, in Participants With Compensated Cirrhosis (F4) Due to Nonalcoholic Steatohepatitis (NASH)

Phase 2

Kamiya Makoto

Updated 10/17/2023

A study to assess the safety and efficacy of Semaglutide and the fixed dose combination of Cilofexor and Firsocostat, alone and in combination, in subjects with Chirrhosis due to Nonalcoholic Steatohepatitis (NASH)

Phase 1

Gilead Sciences, Inc.

Updated 3/2/2022

A Phase 2, Randomized, Double-Blind, Double-Dummy, Multicenter,Prospective Study to Assess the Efficacy, Safety and Pharmacokinetics of 2Dose Regimens of TP-434 Compared with Ertapenem in Adult Community-Acquired Complicated Intra-abdominal Infections

Tetraphase Pharmaceuticals, Inc.

Updated 1/21/2013

Multicenter Study to Test Efficacy and Safety of TP-434 Compared with Ertapenem in Adult Community-Acquired Complicated Intra-abdominal Infections

Tetraphase Pharmaceuticals, Inc.

Updated 7/17/2012

A study to assess the safety and efficacy of Semaglutide and the fixed dose combination of Cilofexor and Firsocostat, alone and in combination, in subjects with Chirrhosis due to Nonalcoholic Steatohepatitis (NASH)

Phase 1

Gilead Sciences, Inc.

Updated 4/4/2022

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

Recruitment & Eligibility

Study & Design

Related Trials

Monoclonal Antibody Therapy against Chronic Herpes Simplex Virus 2 infectio

Study Evaluating the Safety and Efficacy of Semaglutide, and the Fixed-Dose Combination of Cilofexor and Firsocostat, Alone and in Combination, in Participants With Compensated Cirrhosis (F4) Due to Nonalcoholic Steatohepatitis (NASH)

A study to assess the safety and efficacy of Semaglutide and the fixed dose combination of Cilofexor and Firsocostat, alone and in combination, in subjects with Chirrhosis due to Nonalcoholic Steatohepatitis (NASH)

A Phase 2, Randomized, Double-Blind, Double-Dummy, Multicenter,Prospective Study to Assess the Efficacy, Safety and Pharmacokinetics of 2Dose Regimens of TP-434 Compared with Ertapenem in Adult Community-Acquired Complicated Intra-abdominal Infections

Multicenter Study to Test Efficacy and Safety of TP-434 Compared with Ertapenem in Adult Community-Acquired Complicated Intra-abdominal Infections

A study to assess the safety and efficacy of Semaglutide and the fixed dose combination of Cilofexor and Firsocostat, alone and in combination, in subjects with Chirrhosis due to Nonalcoholic Steatohepatitis (NASH)

Clinical Trial Alerts

Clinical Trial Alerts