NCT01802918

Single Dose Escalation Study of GSK2838232 in Healthy Subjects

A Double-Blind, Randomized, Placebo-Controlled, Single Dose Escalation First Time in Human Study to Investigate the Safety, Tolerability and Pharmacokinetics of GSK2838232 and to Evaluate the Effect of Food and Ritonavir on GSK2838232 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

GSK2838232 is a novel human immune virus (HIV) maturation inhibitor being developed for the treatment of chronic HIV infection. This study is the first administration of GSK2838232 in humans to establish the initial safety, tolerability, and pharmacokinetic profile following single doses of GSK2838232 and to evaluate the effect of food and ritonavir (RTV) on GSK2838232 in healthy subjects. There will be 2 cohorts in this study. In Cohort 1, approximately 8 healthy subjects will be enrolled (6 active and 2 placebo) at each dose visit. There will be four dosing sessions for each subject with subjects randomized to receive placebo in a random sequence. In Cohort 2, approximately 8 healthy subjects will be enrolled (6 active doses and 2 placebo doses at each dose visit). Cohort 2 will have four dosing sessions for each subject with subjects randomized to receive placebo in a random sequence.

Conditions

• Infection, Human Immunodeficiency Virus

Interventions

Type	Name	Description
DRUG	GSK2838232	Bottled powder with 5, 10 and 20mg unit dose strength per single dose for re-constituted oral suspension given once daily
DRUG	Placebo	Visually matching GSK2838232
DRUG	Ritonavir	100mg tablets once daily for 12 days

Timeline

• Start date: 2013-02-18
• Primary completion: 2013-11-21
• Completion: 2013-11-21
• First posted: 2013-03-04
• Last updated: 2017-05-09

Locations

1 site across 1 country: United States