NCT01563328

A Study to Evaluate the Effect of Boceprevir and Telaprevir on Dolutegravir Pharmacokinetics in Healthy Adult Subjects (ING115697).

A Phase I, Open Label, Randomized, Two Cohort, Two Period, Oneway Study to Evaluate the Effect of Boceprevir and Telaprevir onDolutegravir Pharmacokinetics in Healthy Adult Subjects (ING115697)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Dolutegravir (DTG, GSK1349572) is an integrase inhibitor that is currently in Phase 3 clinical development for the treatment of human immunodeficiency virus (HIV) infection. Co-infection with Hepatitis C (HCV) is common in HIV-infected subjects therefore it is expected that DTG will be coadministered with treatments for HCV. Boceprevir (BCV) and Telaprevir (TVR) are protease inhibitors for the treatment of HCV that were recently approved by the Food and Drug Administration/European Medicines Agency (FDA/EMA) and have rapidly been adopted to "standard of care" in combination with pegylated interferon and ribavarin. This is a single-center, open-label, two-cohort, two-period, one-way, study in healthy adult subjects. A total of approximately 32 subjects will be enrolled, in order to obtain 24 evaluable subjects (12 per cohort). In the first treatment period, all subjects will receive DTG 50 mg once daily for 5 days (treatment A). In period 2, subjects will receive DTG 50 mg once daily plus either BCV 800 mg q8h (treatment B) for 10 days or TVR 750 mg q8h (treatment C) for 10 days. There will be no washout between treatments. Safety evaluations and serial PK samples will be collected during each treatment period. Subjects will have a screening visit within 30 days prior to the first dose of study drug, two treatment periods, and a follow-up visit 7-14 days after the last dose of study drug. This study will be conducted at one center in the US, with healthy adult male and female subjects.

Conditions

• Infection, Human Immunodeficiency Virus

Interventions

Type	Name	Description
DRUG	DTG	50 mg q24h
DRUG	BCV	800 mg q8h
DRUG	TVR	750 mg q8h

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2012-03-26
• Last updated: 2017-03-28

Locations

1 site across 1 country: United States