Investigation of Ritonavir Effects on Afatinib Exposure in Healthy Subjects
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
2 other identifiers
interventional
24
1 country
1
Brief Summary
To study the effect of the P-glycoprotein inhibitor ritonavir on the pharmacokinetics (PK) of afatinib depending on the timepoint of ritonavir administration
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 30, 2011
CompletedFirst Posted
Study publicly available on registry
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedResults Posted
Study results publicly available
December 19, 2013
CompletedJune 9, 2014
October 1, 2013
4 months
August 30, 2011
August 8, 2013
June 3, 2014
Conditions
Outcome Measures
Primary Outcomes (3)
Area Under Curve From 0 to tz (AUC0-tz)
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.
0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post
Maximum Concentration (Cmax)
Cmax represents the maximum concentration of the analyte in plasma.
0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post
Area Under Curve From 0 to ∞ Hours (AUC0-∞)
AUC0-∞ represents the area under the concentration curve of the analyte in plasma from 0 extrapolated to infinity.
0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post
Study Arms (3)
treatment A
ACTIVE COMPARATOR1 tablet afatinib single dose
treatment B
EXPERIMENTAL2 x 2 tablets ritonavir for 3 days + 1 tablet afatinib on the second treatment day
treatment C
EXPERIMENTAL2 x 2 tablets ritonavir for 3 days + 1 tablet afatinib on the second treatment day
Interventions
simultaneous intake of ritonavir and afatinib on second treatment day
Eligibility Criteria
You may qualify if:
- \. healthy male subjects
You may not qualify if:
- \. any relevant deviation from healthy conditions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
1200.151.1 Boehringer Ingelheim Investigational Site
Biberach, Germany
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim Call Center
- Organization
- Boehringer Ingelheim Pharmaceuticals
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2011
First Posted
September 1, 2011
Study Start
August 1, 2011
Primary Completion
December 1, 2011
Last Updated
June 9, 2014
Results First Posted
December 19, 2013
Record last verified: 2013-10