- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01426958
Investigation of Ritonavir Effects on Afatinib Exposure in Healthy Subjects
June 3, 2014 updated by: Boehringer Ingelheim
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
To study the effect of the P-glycoprotein inhibitor ritonavir on the pharmacokinetics (PK) of afatinib depending on the timepoint of ritonavir administration
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Biberach, Germany
- 1200.151.1 Boehringer Ingelheim Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion criteria:
1. healthy male subjects
Exclusion criteria:
1. any relevant deviation from healthy conditions
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: treatment A
1 tablet afatinib single dose
|
standard therapeutic dose
|
Experimental: treatment B
2 x 2 tablets ritonavir for 3 days + 1 tablet afatinib on the second treatment day
|
simultaneous intake of ritonavir and afatinib on second treatment day
on the second treatment day the first ritonavir tablet will be taken 6 hours after the afatinib tablet
|
Experimental: treatment C
2 x 2 tablets ritonavir for 3 days + 1 tablet afatinib on the second treatment day
|
simultaneous intake of ritonavir and afatinib on second treatment day
on the second treatment day the first ritonavir tablet will be taken 6 hours after the afatinib tablet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post
|
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.
|
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-∞)
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.
|
0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2011
Primary Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
August 30, 2011
First Submitted That Met QC Criteria
August 31, 2011
First Posted (Estimate)
September 1, 2011
Study Record Updates
Last Update Posted (Estimate)
June 9, 2014
Last Update Submitted That Met QC Criteria
June 3, 2014
Last Verified
October 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antineoplastic Agents
- Protease Inhibitors
- Protein Kinase Inhibitors
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- HIV Protease Inhibitors
- Viral Protease Inhibitors
- Ritonavir
- Afatinib
Other Study ID Numbers
- 1200.151
- 2011-001803-11 (EudraCT Number: EudraCT)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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