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Investigation of Ritonavir Effects on Afatinib Exposure in Healthy Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01426958
First Posted: September 1, 2011
Last Update Posted: June 9, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boehringer Ingelheim
  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
Intervention Model: Crossover Assignment
Masking: None (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 ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01426958     History of Changes
Other Study ID Numbers: 1200.151
2011-001803-11 ( EudraCT Number: EudraCT )
First Submitted: August 30, 2011
First Posted: September 1, 2011
Results First Submitted: August 8, 2013
Results First Posted: December 19, 2013
Last Update Posted: June 9, 2014
Last Verified: October 2013

Additional relevant MeSH terms:
Ritonavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors