A clinical trial to check activity of certain enzymes in the body after taking a drug called AEB071
Phase 1
Completed
- Registration Number
- CTRI/2009/091/000582
- Lead Sponsor
- ovartis Healthcare Pvt. Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 18
Inclusion Criteria
Non-smokers
Age: 18 to 45 years
Good health conditions
Post-menopausal or surgically sterilised females
Exclusion Criteria
Use of any prescription drugs within 4weeks prior to dosing.
Donation or loss of 400ml or more blood.
Significant illness subjects.
No significant ECG abnormalities.
History of immunodefficiency disease.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method to quantify the change from baseline in caffeine pharmacokinetics when co-administered with single dose of AEB071Timepoint: NI
- Secondary Outcome Measures
Name Time Method to assess safety and tolerability of AEB071 during multiple dose administration in healthy subjects alone and when combined with caffeineTimepoint: NI