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Drug Interaction Study With Rifampicin and Afatinib

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01396265
First received: July 15, 2011
Last updated: June 3, 2014
Last verified: October 2013
  Purpose

The objective of the current study is to investigate the effect of the P-gp inducer rifampicin on the pharmacokinetics (PK) of afatinib in healthy male volunteers


Condition Intervention Phase
Healthy
Drug: Afatinib
Drug: Rifampicin
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Relative Bioavailability of a Single Oral Dose of 40 mg Afatinib Given Alone and After Multiple Doses of Rifampicin - an Open-label, Two-period, Fixed Sequence Clinical Phase I 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 Infinity Hours (AUC0-∞) [ Time Frame: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose ] [ Designated as safety issue: No ]
    AUC0-∞ represents the area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.

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

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


Secondary Outcome Measures:
  • Time From Dosing to the Maximum Concentration of Afatinib in Plasma (Tmax) [ Time Frame: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose ] [ Designated as safety issue: No ]
    tmax represents the time from dosing to the maximum concentration of the analyte in plasma

  • Terminal Half-life of Afatinib in Plasma (t1/2) [ Time Frame: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose ] [ Designated as safety issue: No ]
    t1/2 represents the terminal half-life of the analyte in plasma

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

  • Percentage of the AUCtz-∞ Obtained by Extrapolation (%AUCtz-∞) [ Time Frame: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose ] [ Designated as safety issue: No ]
    %AUCtz-∞ represents the percentage of the AUCtz-∞ obtained by extrapolation

  • Mean Residence Time of Afatinib in the Body After Oral Administration (MRTpo) [ Time Frame: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose ] [ Designated as safety issue: No ]
    MRTpo represents the mean residence time of the analyte in the body after oral administration

  • Apparent Clearance of Afatinib in the Plasma After Extravascular Administration (CL/F) [ Time Frame: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose ] [ Designated as safety issue: No ]
    CL/F represents the apparent clearance of the analyte in the plasma after extravascular administration

  • Apparent Volume of Distribution During the Terminal Phase lambda_z Following an Extravascular Dose (V_z/F) [ Time Frame: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose ] [ Designated as safety issue: No ]
    V_z/F represents the apparent volume of distribution during the terminal phase λz following an extravascular dose


Enrollment: 22
Study Start Date: July 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Afatinib alone (Reference)
Tablet, Oral administration with 240 mL of water
Drug: Afatinib
single dose
Experimental: Rifampicin + Afatinib (Test)
Tablet, Oral administration with 240 mL of water
Drug: Afatinib
single dose
Drug: Rifampicin
multiple doses

  Eligibility

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

Inclusion criteria:

Healthy male volunteers

Exclusion criteria:

Any relevant deviations from healthy conditions

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01396265

Locations
Germany
1200.152.1 Boehringer Ingelheim Investigational Site
Biberach, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01396265     History of Changes
Other Study ID Numbers: 1200.152, 2011-001804-37
Study First Received: July 15, 2011
Results First Received: August 8, 2013
Last Updated: June 3, 2014
Health Authority: Germany:
United States: Food and Drug Administration

Additional relevant MeSH terms:
Rifampin
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antitubercular
Antitubercular Agents
Enzyme Inhibitors
Leprostatic Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014