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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01371006
First received: June 9, 2011
Last updated: November 8, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: low dose
Drug: normal dose
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Multiple Dosing With 240mg q 12hrs BI 201335 on the Pharmacokinetics of 50 mg Single Dose Efavirenz and Effect of Multiple Dosing With 600mg QD Efavirenz on Cyp 3A4 and the Pharmacokinetics of BI 201335 in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Group A - Efavirenz: Cmax [ Time Frame: Days 1 and 14 ] [ Designated as safety issue: No ]
  • Group A - Efavirenz: AUC0-infinity [ Time Frame: Days 1 and 14 ] [ Designated as safety issue: No ]
  • Group B - BI 201335: Cmax [ Time Frame: Days 9 and 18 ] [ Designated as safety issue: No ]
  • Group B - BI 201335: AUC0-12h [ Time Frame: Days 9 and 18 ] [ Designated as safety issue: No ]
  • Group B - BI 201335: C12h [ Time Frame: Days 9 and 18 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Group A - BI 201335: Cmax [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
  • Group A - BI 201335: Tmax [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
  • Group A - BI 201335: AUC0-12 [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
  • Group A - BI 201335: C12 [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
  • Group B- BI 201335: Tmax [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
  • Group A - Efavirenz: Tmax [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
  • Group B - Midazolam: Cmax [ Time Frame: Days 1, 9 and 19 ] [ Designated as safety issue: No ]
  • Group B - Midazolam: Tmax [ Time Frame: Days 1, 9 and 19 ] [ Designated as safety issue: No ]
  • Group B - Midazolam: AUC0-infinity [ Time Frame: Days 1, 9 and 19 ] [ Designated as safety issue: No ]
  • Changes from baseline in Physical examination [ Time Frame: up to day 24 ] [ Designated as safety issue: No ]
  • Changes from baseline in Vital signs (blood pressure, pulse rate) [ Time Frame: up to day 24 ] [ Designated as safety issue: No ]
  • Changes from baseline in Laboratory tests [ Time Frame: up to day 24 ] [ Designated as safety issue: No ]
  • Changes from baseline in 12-lead ECG [ Time Frame: up to day 24 ] [ Designated as safety issue: No ]
  • Incidence of Adverse events [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]

Enrollment: 29
Study Start Date: June 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI201335 low dose Efavirenz
low dose Efavirenz
Drug: low dose
Efavirenz single dosing once daily
Experimental: BI201335 high dose Efavirenz
normal dose Efavirenz
Drug: low dose
efavirenz single dosing once daily
Drug: normal dose
efavirenz once daily

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01371006

Locations
Switzerland
1220.20.41001 Boehringer Ingelheim Investigational Site
Basel, Switzerland
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01371006     History of Changes
Other Study ID Numbers: 1220.20
Study First Received: June 9, 2011
Last Updated: November 8, 2013
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Efavirenz
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on April 22, 2014