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Investigation of Ritonavir Effects on Afatinib Exposure in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01426958
First received: August 30, 2011
Last updated: May 2, 2012
Last verified: May 2012
History of Changes
  Purpose

To study the effect of the P-glycoprotein inhibitor ritonavir on the pharmacokinetics (PK) of afatinib depending on the timepoint of ritonavir administration


Condition Intervention Phase
Healthy
 Drug: afatinib
Drug: ritonavir + afatinib
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Relative Bioavailability of a Single Oral Dose of 40 mg Afatinib Given Alone Compared to Concomitant and Timed Administration of Multiple Oral Doses of Ritonavir - an Open-label, Randomised, Three-way Crossover Trial in Healthy Male Volunteers

Resource links provided by NLM:

Drug Information available for: Ritonavir
U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • area under the concentration-time curve of afatinib in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz) [ Time Frame: 120 hours ] [ Designated as safety issue: No ]
  • (maximum measured concentration of afatinib in plasma (Cmax) [ Time Frame: 120 hours ] [ Designated as safety issue: No ]
  • area under the concentration-time curve of afatinib in plasma over the time interval from 0 to infinity (AUC0-8) [ Time Frame: 120 hours ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: August 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: treatment A
1 tablet afatinib single dose
 Drug: afatinib
standard therapeutic dose
Experimental: treatment B
2 x 2 tablets ritonavir for 3 days + 1 tablet afatinib on the second treatment day
 Drug: ritonavir + afatinib
simultaneous intake of ritonavir and afatinib on second treatment day
Experimental: treatment C
2 x 2 tablets ritonavir for 3 days + 1 tablet afatinib on the second treatment day
 Drug: ritonavir + afatinib
on the second treatment day the first ritonavir tablet will be taken 6 hours after the afatinib tablet

  Eligibility

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

Inclusion criteria:

1. healthy male subjects

Exclusion criteria:

1. any relevant deviation from healthy conditions

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01426958

Locations
Germany
1200.151.1 Boehringer Ingelheim Investigational Site
Biberach, Germany
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01426958     History of Changes
Other Study ID Numbers: 1200.151, 2011-001803-11
Study First Received: August 30, 2011
Last Updated: May 2, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration

Additional relevant MeSH terms:
Ritonavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013