NCT02289495

A Repeat Dose Pharmacokinetic (PK) and Safety Study of GSK2838232 With and Without Ritonavir (RTV) Conducted in Healthy Subjects

A Double Blind, Placebo Controlled, Single and Repeat Dose Escalation Study of GSK2838232 With and Without Ritonavir for 8-11 Days in Healthy Subjects

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The proposed study, 200207 is a double blind, placebo controlled, single and repeat dose escalation study to investigate the safety, tolerability and PK of GSK2838232 alone and when co-administered with RTV 100 milligram (mg) Once daily (QD). This study will enable future clinical development of GSK2838232 in healthy subjects and in a Phase IIa proof of concept study in Human Immunodeficiency Virus (HIV) infected patients. This study is a single and repeat dose escalation study and will be conducted as two Parts. Part A will evaluate GSK2838232 20 mg and 50 mg administered QD for 8 days and Part B will evaluate GSK2838232 10 mg, 20 mg, and 50 mg, co-administered with RTV 100 mg, QD for 11 days. The extended period of dosing is to account for the longer terminal phase half-life of GSK2838232 when given with RTV. Dose cohorts will be enrolled sequentially; enrollment into a cohort will commence following review of interim PK and safety data from at least 4 subjects in the preceding cohort. Subjects in both parts will have a screening visit within 30 days prior to first dose and a follow-up visit 7-14 days after the last dose. Maximum duration of study participation will be approximately 7 weeks. Approximately 40 healthy subjects will be enrolled, 8 subjects/cohort. Subjects will be randomized 3:1 to receive GSK2838232 or placebo.

Conditions

• Infection, Human Immunodeficiency Virus

Interventions

Type	Name	Description
DRUG	GSK2838232	GSK2838232 will be available as oral suspension dispersion in hydromellulose acetate succinate bulk powder/10, 20 and 50 mg which is to be administered orally QD for 8 days (Part A) or 11 days (Part B), morning dose, following an overnight fast of at least 10 hours
DRUG	Placebo	Matching placebo of Suspension to active dose, administered orally QD for 8 days (Part A) or 11 days (Part B), morning dose, following an overnight fast of at least 10 hours
DRUG	Ritonavir	Ritonavir will be available as white film-coated ovaloid tablets of 100 mg tablet/100mg to be administer orally, QD

Timeline

• Start date: 2014-11-18
• Primary completion: 2015-06-27
• Completion: 2015-06-27
• First posted: 2014-11-13
• Last updated: 2017-05-09

Locations

1 site across 1 country: United States