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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: normal dose; Drug: low dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT01371006

1220.20

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Healthy volunteers age 18- 55 BMI (Body Mass Index) 18.5 - 29.9

Exclusion criteria

1. Any finding on medical examination and ECG (Electrocardiography) deviating from normal
2. Active diseases
3. History of photosensitivity or rash

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

29 participants in 2 patient groups

BI201335 low dose Efavirenz

Experimental group

Description:

low dose Efavirenz

Treatment:

Drug: low dose

Drug: low dose

BI201335 high dose Efavirenz

Experimental group

Description:

normal dose Efavirenz

Treatment:

Drug: low dose

Drug: normal dose

Drug: low dose