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Effect of BMS-914392 on Pharmacokinetics of Metoprolol

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Atrial Fibrillation

Intervention: metoprolol (Drug); BMS-914392 (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome: Pharmacokinetics of single dose of metoprolol derived from serial measurements of metoprolol plasma concentrations

Secondary outcome:

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

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

Detailed description: Protocol designed to evaluate the potential for a drug-drug-interaction

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

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

Locations and Contacts

Pra International, Lenexa, Kansas 66219, United States
Additional Information

BMS Clinical Trials Disclosure

Investigator Inquiry form

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

Starting date: September 2010
Last updated: February 1, 2011

Page last updated: August 23, 2015

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