Overview

Effect of BMS-914392 on Pharmacokinetics of Metoprolol

Status:
Completed
Trial end date:
2010-11-01
Target enrollment:
0
Participant gender:
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 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Bristol-Myers Squibb
Collaborator:
PRA Health Sciences
Treatments:
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