NCT04079790

Pharmacokinetics of Gepotidacin Tablets in Adults and Adolescents Subjects

A Phase I, Double-Blind, Two-Part, Sequential Study to Evaluate the Pharmacokinetics of Gepotidacin Tablets in Healthy Adult and Adolescent Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 12 Years – 64 Years
• Healthy volunteers: Accepted

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.

Conditions

• Infections, Bacterial

Interventions

Type	Name	Description
DRUG	Gepotidacin	Tablets containing gepotidacin mesylate with a unit dose of 750 mg will be administered orally with 240 milliliter (mL) of water.
DRUG	Placebo	Tablets containing unit dose of placebo matching of gepotidacin will be administered orally with 240 mL of water.

Timeline

• Start date: 2019-09-04
• Primary completion: 2019-11-25
• Completion: 2019-11-25
• First posted: 2019-09-06
• Last updated: 2020-09-04
• Results posted: 2020-09-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study