Ignite Creation Date:
2024-05-06 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 2:19 PM
Study NCT ID:
NCT05138822
Status:
RECRUITING
Last Update Posted:
2023-10-23
First Post:
2021-11-15
Brief Title:
Safety Tolerability Pharmacokinetic and Microbiological Investigation of GSK3882347 in Female Participants With Urinary Tract Infections
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study 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
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
To allow analysis of data from supplementary non-clinical study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None