Ignite Creation Date:
2024-05-06 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 12:48 PM
Study NCT ID:
NCT03568942
Status:
COMPLETED
Last Update Posted:
2020-06-29
First Post:
2018-06-11
Brief Title:
Pharmacokinetic Study of Oral Gepotidacin GSK2140944 in Subjects With Uncomplicated Urinary Tract Infection Acute Cystitis
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Phase IIa Single-Center Open-Label Study Evaluating the Pharmacokinetics of Repeat Oral Doses of Gepotidacin GSK2140944 in Adult Female Participants With Uncomplicated Urinary Tract Infection Acute Cystitis
Status:
COMPLETED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Gepotidacin GSK2140944 is a novel triazaacenaphthylene bacterial type II topoisomerase inhibitor that is being developed for the treatment of uncomplicated urinary tract infections UTIs acute cystitis This Phase IIa study will evaluate plasma and urine pharmacokinetics of gepotidacin in female subjects with acute cystitis Eligible female subjects will receive twice daily BID dose of gepotidacin 1500 milligram mg for 5 days via oral route Pre-treatment and post-treatment samples for pharmacokinetic PK assessments will be collected throughout the study The total duration of the study is approximately 28 days
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?:
None
Is an FDA AA801 Violation?:
None