NCT02082808

Study to Evaluate the Drug Interaction Between Dolutegravir (DTG) and Daclatasvir (DCV) in Healthy Adult Subjects

A Phase 1, Open-Label, Crossover Study to Evaluate the Drug Interaction Between Dolutegravir and Daclatasvir in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study is designed to estimate the two-way drug interaction between DCV and DTG as a drug interaction between DTG and DCV is expected to be low and this study is to be performed as confirmation. This will be a single-center, open-label, three-period, crossover study in healthy adult subjects. This study to describe and compare steady-state plasma DTG and DCV pharmacokinetics following administration of DTG 50 mg q24h with and without DCV 60 mg q24h and following administration of DCV 60 mg q24h with and without DTG 50 mg q24h also the safety and tolerability was assessed after a repeat dose DTG 50 mg q24h with or without DCV 60 mg q24h and after a repeat dose DCV 60 mg q24h with and without DTG 50 mg q24h

Conditions

• Infection, Human Immunodeficiency Virus

Interventions

Type	Name	Description
DRUG	DTG	DTG is provided as 9 millimetre white, film-coated, round tablets debossed with SV 572 on one side and 50 on the other side
DRUG	DCV	DCV is provided as a plain, green, biconvex, pentagonal film-coated tablet

Timeline

• Start date: 2014-03-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2014-03-10
• Last updated: 2014-06-09

Locations

1 site across 1 country: United States