Overview

Effect of Carbamazepine on Dolutegravir Pharmacokinetics in Healthy Adult Subjects

Status:
Completed
Trial end date:
2014-01-01
Target enrollment:
Participant gender:
Summary
This study will be a phase I, open label, three period, fixed sequence crossover study to evaluate the effect of Carbamazepine (CBZ) on the steady-state pharmacokinetics of Dolutegravir (DTG) and on the safety and tolerability of DTG. Subjects will have a screening visit within 30 days prior to the first dose of study drug, three treatment periods, and a follow-up visit 7-14 days after the last dose of study drug. There is no washout between treatment periods.
Phase:
Phase 1
Details
Lead Sponsor:
ViiV Healthcare
Collaborator:
GlaxoSmithKline
Treatments:
Carbamazepine
Dolutegravir