Effect of BMS-914392 on Pharmacokinetics of Metoprolol

Effect of BMS-914392 on the Pharmacokinetics of Metoprolol and on Heart Rate After Co-administration of BMS-914392 and Metoprolol in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01211821

Enrollment

Registered

2010-09-30

Start date

2010-09-30

Completion date

2010-11-30

Last updated

2011-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

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

Interventions

DRUGBMS-914392

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

DRUGmetoprolol

Tablets, Oral, 200 mg, once, 1 day

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026