Pharmacokinetics of Gepotidacin Tablets in Adults and Adolescents Subjects
Status:
Completed
Trial end date:
2019-11-25
Target enrollment:
Participant gender:
Summary
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.