NCT01802918

Single Dose Escalation Study of GSK2838232 in Healthy Subjects

Completed Phase 1 Last updated 9 May 2017

What this trial tests

Phase 1 trial testing GSK2838232 in Infection, Human Immunodeficiency Virus in 17 participants. Completed in 21 November 2013.

Timeline

18 February 2013

Primary endpoint
21 November 2013

21 November 2013

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	17
Start date	18 February 2013
Primary completion	21 November 2013
Estimated completion	21 November 2013
Sites	1 location across United States

Drugs / interventions tested

• GSK2838232 — full drug profile →
• Placebo
• Ritonavir (ritonavir) — full drug profile →

Conditions studied

• Infection, Human Immunodeficiency Virus — all drugs for Infection, Human Immunodeficiency Virus →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 50, any sex, with Infection, Human Immunodeficiency Virus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The safety, tolerability, and pharmacokinetic profile of GSK2838232, a novel 2nd generation HIV maturation inhibitor, as assessed in healthy subjects.
   Johnson M, Jewell RC, Peppercorn A, Gould E, et al · · 2018 · cited 11× · PMID 29930812 · DOI 10.1002/prp2.408