Effect of BMS-914392 on Pharmacokinetics of Metoprolol

February 1, 2011 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Lenexa, Kansas, United States, 66219
        • PRA International

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: metoprolol
Treatment A
Drug: metoprolol
Tablets, Oral, 200 mg, once, 1 day
Experimental: BMS-914392 + metoprolol
Treatment B
Drug: metoprolol
Tablets, Oral, 200 mg, once, 1 day
Drug: BMS-914392
Tablets, Oral, 60 mg, once daily, 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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

Outcome Measure
Time Frame
Number of subjects with adverse events as a measure of safety and tolerability of BMS-914392
Time Frame: Daily
Daily
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Collaborators

PRA Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

September 3, 2010

First Submitted That Met QC Criteria

September 28, 2010

First Posted (Estimate)

September 30, 2010

Study Record Updates

Last Update Posted (Estimate)

February 2, 2011

Last Update Submitted That Met QC Criteria

February 1, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV203-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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