drugset / Trial / NCT01371006

Evaluation of the Effect of Multiple Dosing With BI 201335 on CYP2B6 Metabolism and Effect of Multiple Dosing With Efavirenz on the Steady-state Pharmacokinetics of BI 201335 and on CYP3A4/5 Metabolism in Healthy Volunteers

NCT01371006

Phase 1 Completed 29 enrolled Boehringer Ingelheim
Non-randomizedParallel-groupOpen-labelTreatment

Summary

Obtain interaction data between BI 201335 and Efavirenz to guide dosing for each drug when administered together. To predict drug interaction between BI 201335 and Cyp 3A4 y using Midazolam as cyp 3A4 probe , Efavirenz as enzyme inducer and BI 201335 as enzyme inhibitor.

Timeline

Start
2011-06
Primary completion
2011-09
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Efavirenz Other / unclassified 50 mg
Subject Efavirenz Other / unclassified 600 mg

Indications

No indication recorded.