Trial Profile
A Pharmacokinetic, Multi-cohort Study in Healthy Adult Subjects to Assess Gepotidacin as Victim and as Perpetrator of Drug-Drug Interactions Via CYP450, Renal and Intestinal Transporters, and to Assess Gepotidacin Pharmacokinetics in Japanese Healthy Adults
Status:
Completed
Phase of Trial:
Phase I
Latest Information Update: 17 Jan 2023
Price :
$35
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At a glance
- Drugs Gepotidacin (Primary) ; Cimetidine; Digoxin; Midazolam; Rifampicin
- Indications Bacterial infections
- Focus Adverse reactions; Pharmacokinetics
- Sponsors GlaxoSmithKline; GSK
- 01 Jan 2023 Results assessing the pharmacokinetics and interethnic comparisons of oral gepotidacin (free-base and to-be-marketed mesylate formulations) administered as single doses ranging from 1500 to 3000 mg in fed and fasted states, and as 2 x 3000-mg doses given 12 hours apart under fed conditions in healthy participants of Japanese ancestry from NCT02853435 and NCT04493931 studies, published in the Clinical Pharmacology in Drug Development.
- 27 Sep 2022 Results (n=14) assessing the pharmacokinetics, safety, and tolerability of a single oral dose of 1,500 mggepotidacin and 2*3,000 mg doses of gepotidacin in healthy adult Japanese participants and the effect of a standard Japanese meal on the PK of the to-be-marketed formulation, and to compare results with those of Western participants, presented at the 2022 American College of Clinical Pharmacology Annual Meeting.
- 09 Dec 2021 Number of treatment arms have been decreased from 8 to 7 by the removal of Placebo Comparator: Cohort 4: Placebo fasted then fed then fed arm. Primary end points have been updated with the addition of some new safety end-points and the removal of some previous ones.