Investigation of Ritonavir Effects on Afatinib Exposure in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01426958
First received: August 30, 2011
Last updated: October 29, 2013
Last verified: October 2013
  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:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Area Under Curve From 0 to tz (AUC0-tz) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post ] [ Designated as safety issue: No ]
    AUC0-tz represents the area under the concentration curve of the analyte in plasma from 0 to the time of the last quantifiable plasma contentration of the analyte.

  • Maximum Concentration (Cmax) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post ] [ Designated as safety issue: No ]
    Cmax represents the maximum concentration of the analyte in plasma.

  • Area Under Curve From 0 to ∞ Hours (AUC0-∞) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post ] [ Designated as safety issue: No ]
    AUC0-∞ represents the area under the concentration curve of the analyte in plasma from 0 extrapolated to infinity.


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
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01426958     History of Changes
Other Study ID Numbers: 1200.151, 2011-001803-11
Study First Received: August 30, 2011
Results First Received: August 8, 2013
Last Updated: October 29, 2013
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 April 17, 2014