Effect of Carbamazepine on Dolutegravir Pharmacokinetics in Healthy Adult Subjects

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.

Timeline

Start

2013-10

Primary completion

2014-01

Completion

2014-01

Publications

• Song I, Weller S, Patel J, Borland J, Wynne B, Choukour M, Jerva F, Piscitelli S. Effect of carbamazepine on dolutegravir pharmacokinetics and dosing recommendation. Eur J Clin Pharmacol. 2016 Jun;72(6):665-70. doi: 10.1007/s00228-016-2020-6. Epub 2016 Feb 22.

Drugs

Indications