NCT02289482

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

A Double-Blind, Randomized, Placebo-Controlled, Continuation Single Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of GSK2838232 With and Without Ritonavir, and to Evaluate Different Formulations of GSK2838232, in Healthy Subjects

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study investigates the safety, tolerability and PKs of GSK2838232 with and without Ritonavir, and to evaluate different formulations of GSK2838232 in healthy subjects. This study will evaluate higher single and RTV boosted doses to support continued clinical development of GSK2838232 at clinically relevant doses, and subsequently in those infected with HIV in a dose ranging phase 2 study. The study is conducted in 2 parts: Part A and Part B, study Part A and Part B may be conducted in parallel. Approximately 20 healthy subjects will be enrolled into the study, 8 in Part A and 12 in Part B. Part A is a double-blind, randomized, placebo-controlled, 4-period, single dose escalation design. Subjects will be randomized 3:1 to receive GSK2838232 or placebo. Subjects randomized to placebo will receive placebo in all four periods. Following completion of Period 2 PK assessments at 96hr post-dose, subjects will begin daily dosing of RTV 100mg for a total of 26 days. Part B is a randomized, open-label, unbalanced, 3-period, cross-over design; subjects will be randomized 1:1 to each sequence. The relative bioavailability of single 100mg doses of powder in a bottle (PIB) active pharmaceutical ingredient (API) of GSK2838232 versus PIB spray-dried dispersion (SDD) will be assessed. A single dose of GSK2838232 will co-administered on the 10th day of RTV dosing; RTV dosing will continue for an additional 4 days (total of 14 days). Subjects will have a screening visit within 30 days prior to first dose and a follow-up visit 7-14 days after the last dose.

Conditions

• Infection, Human Immunodeficiency Virus

Interventions

Type	Name	Description
DRUG	GSK2838232 PIB (SDD)	GSK2838232 will be available as oral suspension dispersion in hydromellulose acetate succinate bulk powder/10, 20, 50, 200 and 500 mg in part A, while 100 mg in Part B. GSK2838232 will be administered orally once daily (QD) as single doses in the morning following an overnight fast of at least 10 hours.
DRUG	GSK2838232 PIB (API)	GSK2838232 will be available as oral suspension bulk powder/100 mg in Part B. GSK2838232 will be administered orally QD as single doses in the Morning following an overnight fast of at least 10 hours.
DRUG	Placebo	Matching placebo of Suspension to active dose, administered orally QD as single doses in the morning 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. Ritonavir will be administered orally, once daily in Part A, Period 3 Days 1-14 and Period 4 from Days 1-12 and will be administer orally once daily in Part B for 9 days prior to dosing in Period 3 and on Days 10-14 of Period 3.

Timeline

• Start date: 2014-11-17
• Primary completion: 2015-03-10
• Completion: 2015-03-10
• First posted: 2014-11-13
• Last updated: 2017-05-15

Locations

1 site across 1 country: United States