Skip to main content
OpenTrials
Completed

NCT Number: NCT01396265

Drug Interaction Study With Rifampicin and Afatinib

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

1200.152.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy male volunteers

Exclusion criteria

Any relevant deviations from healthy conditions

Treatment and study plan

afatinib

Drug

single dose

rifampicin

Drug

multiple doses

Primary outcomes

  1. 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

    AUC0-∞ represents the area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.

  2. 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

    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.

  3. 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

    Cmax represents the maximum concentration of the analyte in plasma.

Secondary outcomes

  1. 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

    tmax represents the time from dosing to the maximum concentration of the analyte in plasma

  2. 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

    t1/2 represents the terminal half-life of the analyte in plasma

  3. 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

    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)

  4. 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

    %AUCtz-∞ represents the percentage of the AUCtz-∞ obtained by extrapolation

  5. 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

    MRTpo represents the mean residence time of the analyte in the body after oral administration

  6. 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

    CL/F represents the apparent clearance of the analyte in the plasma after extravascular administration

  7. 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

    V_z/F represents the apparent volume of distribution during the terminal phase λz following an extravascular dose

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
First posted
Jul 18, 2011
Registry last updated
Jun 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.