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A Phase I; Multi-Center; Open-Label (Parts 1 and 2); Randomized, Double-Blind, Placebo-Controlled (Part 3); Single-Dose; 3-Part Study to Evaluate the Relative Bioavailability of Three Formulations in Healthy Subjects, Food Effect on Tablet Formulation in Healthy Subjects, and Pharmacokinetics of Gepotidacin (GSK2140944) in Japanese Subjects in Fasted and Fed States

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Trial Profile

A Phase I; Multi-Center; Open-Label (Parts 1 and 2); Randomized, Double-Blind, Placebo-Controlled (Part 3); Single-Dose; 3-Part Study to Evaluate the Relative Bioavailability of Three Formulations in Healthy Subjects, Food Effect on Tablet Formulation in Healthy Subjects, and Pharmacokinetics of Gepotidacin (GSK2140944) in Japanese Subjects in Fasted and Fed States

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 17 Jan 2023

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At a glance

  • Drugs Gepotidacin (Primary) ; Mesylates
  • Indications Bacterial infections; Gonorrhoea; Skin and soft tissue infections; Urinary tract infections
  • Focus Pharmacokinetics
  • Sponsors GlaxoSmithKline; GSK

    • Most Recent Events

    • 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.
    • 11 Oct 2021 Results assessing pharmacokinetics and safety of Gepotidacin (GSK2140944) in healthy adult and adolescent participants from NCT02853435 and NCT04079790 trials, published in the Antimicrobial Agents and Chemotherapy.
    • 23 Nov 2017 Status changed from active, no longer recruiting to completed.
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