Effect of BMS-914392 on Pharmacokinetics of Metoprolol

Phase 1

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: metoprolol; Drug: BMS-914392

• Registration Number: NCT01211821
• Lead Sponsor: Bristol-Myers Squibb

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

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-03
• Study First Submitted QC: 2010-09-28
• Study First Posted: 2010-09-30
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-01
• Last Update Posted: 2011-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BMS-914392 + metoprolol	BMS-914392	Treatment B
metoprolol	metoprolol	Treatment A
BMS-914392 + metoprolol	metoprolol	Treatment B

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics of single dose of metoprolol derived from serial measurements of metoprolol plasma concentrations	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 Outcome Measures

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

Trial Locations

Locations (1)

Pra International; 🇺🇸 Lenexa, Kansas, United States