Effect of BMS-914392 on Pharmacokinetics of Metoprolol

Bristol-Myers Squibb18 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Atrial Fibrillation

Interventions

metoprololDRUG

Tablets, Oral, 200 mg, once, 1 day

BMS-914392DRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Pra International

Lenexa, Kansas, United States

Outcomes

Primary Outcomes

Pharmacokinetics of single dose of metoprolol derived from serial measurements of metoprolol plasma concentrations

Time frame: Pre-dose and 0.5 Hr, 1 Hr, 1.5 Hr, 2 Hr, 3 Hr, 4 Hr, 6 Hr, 8 Hr, 12 Hr, 24 Hr, and 36 Hr after dosing of metoprolol alone or in combination with BMS-914392

Secondary Outcomes

The effect of multiple doses of BMS-914392 on PR, QRS, RR, and QTc intervals derived from serial electrocardiograms (ECGs)

Time frame: Pre-dose and 0.5 Hr, 1 Hr, 1.5 Hr, 2 Hr, 3 Hr, 4 Hr , 6 Hr, 8 Hr, 12 Hr, 24 Hr after dosing with metoprolol alone or in combination with BMS-914392

Number of subjects with adverse events as a measure of safety and tolerability of BMS-914392

Time frame: Daily

Data from ClinicalTrials.gov

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