Overview
Effect of BMS-914392 on Pharmacokinetics of Metoprolol
Status:
Completed
Completed
Trial end date:
2010-11-01
2010-11-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Bristol-Myers SquibbCollaborator:
PRA Health SciencesTreatments:
Metoprolol
Criteria
Inclusion Criteria:- 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 Criteria:
- 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