NCT01967771

Effect of Carbamazepine on Dolutegravir Pharmacokinetics in Healthy Adult Subjects

A Phase I, Open Label, Randomized, Three Period, Fixed Sequence Crossover Study to Evaluate the Effect of Carbamazepine on Dolutegravir Pharmacokinetics in Healthy Adult Subjects (200901)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Infection, Human Immunodeficiency Virus

Interventions

Type	Name	Description
DRUG	DTG	DTG will be supplied as 50 mg tablet to be administered orally
DRUG	CBZ	CBZ will be supplied as 100 mg and 200 mg extended release tablet to be administered orally

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2013-10-23
• Last updated: 2014-01-27

Locations

1 site across 1 country: United States