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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
140
GSK3882347 will be administered on each dosing day.
Nitrofurantoin will be administered on each dosing day.
Placebo matching study drug (GSK3882347) or Nitrofurantoin will be administered on each dosing day.
GSK Investigational Site
Anniston, Alabama, United States
GSK Investigational Site
Lomita, California, United States
GSK Investigational Site
Modesto, California, United States
GSK Investigational Site
Doral, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Miami Lakes, Florida, United States
GSK Investigational Site
Palmetto Bay, Florida, United States
GSK Investigational Site
Sweetwater, Florida, United States
GSK Investigational Site
Chicago, Illinois, United States
GSK Investigational Site
The Bronx, New York, United States
...and 5 more locations
Numbers of participants with microbiological response (responder/non-responder of GSK3882347) at the test of cure (TOC) visit
Microbiological response is defined as the response of less than (\<)10\^3 colony forming unit (CFU)/milliliter (mL) for all qualifying Escherichia coli (identified at baseline urine microbiology visit) at TOC visit, without receiving other systemic antimicrobials (rescue medications) prior to TOC
Time frame: Day 10 to Day 13
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
AEs and SAEs will be collected.
Time frame: Up to Day 31
Number of participants with clinically significant change from baseline in hematology parameters
Blood samples will be collected for the assessment of hematology parameters.
Time frame: Baseline (Day 1) and up to Day 31
Number of participants with clinically significant change from baseline in clinical chemistry
Blood samples will be collected for the assessment of chemistry parameters.
Time frame: Baseline (Day 1) and up to Day 31
Number of participants with clinically significant change from baseline in urinalysis
Blood samples will be collected for the assessment of urinalysis parameters.
Time frame: Baseline (Day 1) and up to Day 31
Number of participants with clinically significant change from baseline in vital signs
Time frame: Baseline (Day 1) and up to Day 31
Number of participants with clinically significant change from baseline in 12- lead Electrocardiogram (ECG) findings
Time frame: Baseline (Day 1) and up to Day 31
Plasma concentration of GSK3882347 single dose
Blood samples will be collected for the concentrations of GSK3882347.
Time frame: Up to Day 5
Urine concentration of GSK3882347 at 22-24-hour (h) interval collection post-dose
Urine samples will be collected for the concentrations of GSK3882347.
Time frame: Up to Day 5
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