drugset / Trial / NCT04128293

A Relative Bioavailability and Food-Effect Study of GSK3640254 Tablet and Capsule Formulations in Healthy Participants

NCT04128293

Phase 1 Terminated 16 enrolled ViiV Healthcare
RandomizedCrossoverOpen-labelTreatment

Summary

This is an open-label, single-dose, four-period, four sequential, and crossover study conducted to assess the relative bioavailability of GSK3640254 mesylate tablets and GSK3640254 mesylate capsules (in the presence of a moderate fat meal). This study will also evaluate the effect of food (fasted, moderate fat meal, and high fat meal) on the pharmacokinetics of GSK3640254 mesylate tablet formulation. Participants will be randomized to receive a single dose of GSK3640254 200 milligram (mg) capsules under moderate fat conditions and GSK3640254 200 mg tablets under moderate fat, fasted and high fat conditions in each treatment period. Approximately 16 participants will be enrolled and the duration of the study will be approximately 54 days.

Timeline

Start
2019-10-08
Primary completion
2019-11-15
Completion
2019-11-15

Drugs

EvaluationDrugModalityDoseRoute
Subject FIPRAVIRIMAT Small molecule 200 mg Oral