Status:
COMPLETED
Effect of BMS-914392 on Pharmacokinetics of Metoprolol
Lead Sponsor:
Bristol-Myers Squibb
Collaborating Sponsors:
PRA Health Sciences
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to assess the effects of BMS-914392 administration on the pharmacokinetics of a single-dose of metoprolol in healthy subjects.
Detailed Description
Protocol designed to evaluate the potential for a drug-drug-interaction
Eligibility Criteria
Inclusion
- Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations.
- Subjects genotyped as Intermediate, Extensive or Ultra-rapid CYP2D6 metabolizers
- Women of childbearing potential (WOCBP) and men must be using an acceptable method of contraception to avoid pregnancy
Exclusion
- Any significant acute or chronic medical illness.
- Current or recent (within 3 months of study drug administration) gastrointestinal disease.
- Current or history of neurological diseases or psychiatric disorders, cardiovascular diseases, and bronchospastic diseases.
- CYP2D6 poor metabolizers based on genotype
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01211821
Start Date
September 1 2010
End Date
November 1 2010
Last Update
February 2 2011
Active Locations (1)
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1
Pra International
Lenexa, Kansas, United States, 66219