Skip to main content
OpenTrials
Completed

NCT Number: NCT01211821

Effect of BMS-914392 on Pharmacokinetics of Metoprolol

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pra International

Lenexa, Kansas, 66219, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

metoprolol

Drug

Tablets, Oral, 200 mg, once, 1 day

BMS-914392

Drug

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

Primary outcomes

  1. 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

  1. 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

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

    Time frame: Daily

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • PRA Health Sciences

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Sep 30, 2010
Registry last updated
Feb 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.