Effect of BMS-914392 on Pharmacokinetics of Metoprolol

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2010-11-30

Brief Summary

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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.

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Detailed Description

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Protocol designed to evaluate the potential for a drug-drug-interaction

Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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metoprolol

Treatment A

Group Type OTHER

metoprolol

Intervention Type DRUG

Tablets, Oral, 200 mg, once, 1 day

BMS-914392 + metoprolol

Treatment B

Group Type EXPERIMENTAL

metoprolol

Intervention Type DRUG

Tablets, Oral, 200 mg, once, 1 day

BMS-914392

Intervention Type DRUG

Tablets, Oral, 60 mg, once daily, 7 days

Interventions

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metoprolol

Tablets, Oral, 200 mg, once, 1 day

Intervention Type DRUG

BMS-914392

Tablets, Oral, 60 mg, once daily, 7 days

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes