drugset / Trial / NCT04563845

Effect of Therapeutic and Supratherapeutic Oral Doses of GSK3640254 on Cardiac Conduction Compared to Placebo and a Single Oral Dose of Moxifloxacin

NCT04563845

Phase 1 Completed 50 enrolled ViiV Healthcare
RandomizedSequentialDouble-blindTreatment

Summary

This study will aim to evaluate the effect of therapeutic and supratherapeutic oral doses of GSK3640254 on cardiac conduction compared to placebo and a single oral dose of Moxifloxacin in healthy adult participants. The study has 2 parts: Part 1 will determine the supratherapeutic dose for Part 2, which will be the main corrected QT interval (QTc) study. Part 1 will evaluate once daily (QD) dosing of GSK3640254 or placebo and Part 2 will investigate the safety, tolerability and Pharmacokinetics (PK) of GSK3640254 doses on cardiac conduction as compared to placebo and a single oral dose of Moxifloxacin in healthy adult participants. Moxifloxacin will be included as a positive control.

Timeline

Start
2020-11-09
Primary completion
2021-10-30
Completion
2021-10-30

Drugs

EvaluationDrugModalityDoseRoute
Subject FIPRAVIRIMAT Small molecule 100 mg Oral
Subject FIPRAVIRIMAT Small molecule 500 mg Oral
Subject Moxifloxacin Small molecule 400 mg