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OpenTrials
Completed

NCT Number: NCT01426958

Investigation of Ritonavir Effects on Afatinib Exposure in Healthy Subjects

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

Completed

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

1200.151.1 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 subjects

Exclusion criteria

  • any relevant deviation from healthy conditions

Treatment and study plan

afatinib

Drug

standard therapeutic dose

ritonavir + afatinib

Drug

simultaneous intake of ritonavir and afatinib on second treatment day

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

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 Compared to Concomitant and Timed Administration of Multiple Oral Doses of Ritonavir - an Open-label, Randomised, Three-way Crossover Trial in Healthy Male Volunteers

Important dates

Study start
2011
Primary completion
2011
First posted
Sep 1, 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.

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