Who is sponsoring NCT04079790?

NCT04079790 is sponsored by GlaxoSmithKline.

What condition does NCT04079790 study?

NCT04079790 studies Infections, Bacterial.

What drugs are being tested in NCT04079790?

Interventions: Gepotidacin, Placebo.

What is the status of NCT04079790?

NCT04079790 is currently COMPLETED.

Last reviewed 2020-09-04 · How we verify

Pharmacokinetics of Gepotidacin Tablets in Adults and Adolescents Subjects

NCT04079790 PHASE1 COMPLETED Results posted

This is double-blind, randomized, sequential, two part study. Part 1 is a 3 periods, fixed-sequence study and will be conducted to evaluate the pharmacokinetics, safety, and tolerability of the gepotidacin tablet in healthy adult subjects. Part 2 is a 2 periods, fixed-sequence study and will evaluate the pharmacokinetics, safety, and tolerability of the gepotidacin tablet in healthy adolescent subjects. The primary purpose of Part 1 is to evaluate the pharmacokinetics of a single 1500 milligram (mg) dose and two 3000 mg doses of gepotidacin given 6 and 12 hours apart in adult subjects; Part 2 is to evaluate the pharmacokinetics of a single 1500 mg dose and two 3000 mg doses of gepotidacin given at a dosing interval (to be determined based on the pharmacokinetic and safety results from Part 1) in adolescent subjects. The duration of Part A will be approximately 47 days and 52 days for Part 2.

Details

Lead sponsor	GlaxoSmithKline
Phase	PHASE1
Status	COMPLETED
Enrolment	34
Start date	Wed Sep 04 2019 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Mon Nov 25 2019 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Infections, Bacterial

Interventions

Gepotidacin
Placebo

Countries

United States