Effect of BMS-914392 on Pharmacokinetics of Metoprolol

This study has been completed.

Sponsor:

Collaborator:

PRA International

Information provided by:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT01211821

First received: September 3, 2010

Last updated: February 1, 2011

Last verified: February 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

September 3, 2010

Last Updated Date

February 1, 2011

Start Date ^ICMJE

September 2010

Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01211821 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]
Number of subjects with adverse events as a measure of safety and tolerability of BMS-914392 [ Time Frame: Daily ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

The effect of multiple doses of BMS-914392 on PR, QRS, RR, and QTc intervals derived from serial 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 ] [ Designated as safety issue: No ]
Number of subjects with adverse events as a measure of safety and tolerability of BMS-914392 [ Time Frame: Daily ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Effect of BMS-914392 on Pharmacokinetics of Metoprolol

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Atrial Fibrillation

Intervention ^ICMJE

Drug: metoprolol
Tablets, Oral, 200 mg, once, 1 day
Drug: BMS-914392
Tablets, Oral, 60 mg, once daily, 7 days

Study Arm (s)

metoprolol
Treatment A

Intervention: Drug: metoprolol
Experimental: BMS-914392 + metoprolol
Treatment B
Interventions:
- Drug: metoprolol
- Drug: BMS-914392

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2010

Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01211821

Other Study ID Numbers ^ICMJE

CV203-003

Has Data Monitoring Committee

Responsible Party

Study Director, Bristol-Myers Squibb

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

PRA International

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

February 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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