Investigation of Ritonavir Effects on Afatinib Exposure in Healthy Subjects
Information source: Boehringer Ingelheim Pharmaceuticals
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: afatinib (Drug); ritonavir + afatinib (Drug); ritonavir + afatinib (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Boehringer Ingelheim Pharmaceuticals Official(s) and/or principal investigator(s):
Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim Pharmaceuticals
Overall contact:
Boehringer Ingelheim Call Center, Phone: 1-800-243-0127, Email: clintriage.rdg@boehringer-ingelheim.com
Summary
To study the effect of the P-glycoprotein inhibitor ritonavir on the pharmacokinetics (PK)
of afatinib depending on the timepoint of ritonavir administration
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: area under the concentration-time curve of afatinib in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz)(maximum measured concentration of afatinib in plasma (Cmax) area under the concentration-time curve of afatinib in plasma over the time interval from 0 to infinity (AUC0-8)
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Male.
Criteria:
Inclusion criteria:
1. healthy male subjects
Exclusion criteria:
1. any relevant deviation from healthy conditions
Locations and Contacts
Boehringer Ingelheim Call Center, Phone: 1-800-243-0127, Email: clintriage.rdg@boehringer-ingelheim.com
1200.151.1 Boehringer Ingelheim Investigational Site, Biberach, Germany; Recruiting
Additional Information
Starting date: August 2011
Last updated: November 16, 2011
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