Effect of BMS-914392 on Pharmacokinetics of Metoprolol | RxWiki

Effect of BMS-914392 on Pharmacokinetics of Metoprolol

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Atrial Fibrillation
Intervention	Drug: metoprolol Drug: BMS-914392
Phase	Phase 1
Sponsor	Bristol-Myers Squibb
Responsible Party	Bristol-Myers Squibb
ClinicalTrials.gov Identifier	NCT01211821
First Received	September 3, 2010
Last Updated	February 1, 2011
Last verified	February 2011

Tracking Information[ + expand ][ + ]

First Received Date	September 3, 2010
Last Updated Date	February 1, 2011
Start Date	September 2010
Estimated Primary Completion Date	November 2010
Current Primary Outcome Measures	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]
Current Secondary Outcome Measures	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]

Descriptive Information[ + expand ][ + ]

Brief Title	Effect of BMS-914392 on Pharmacokinetics of Metoprolol
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
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	Interventional
Study Phase	Phase 1
Study Design	Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label
Condition	Atrial Fibrillation
Intervention	Drug: metoprolol Tablets, Oral, 200 mg, once, 1 day Drug: BMS-914392 Tablets, Oral, 60 mg, once daily, 7 days
Study Arm (s)	Other: metoprolol Treatment A Experimental: BMS-914392 + metoprolol Treatment B

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	18
Estimated Completion Date	November 2010
Estimated Primary Completion Date	November 2010
Eligibility 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
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT01211821
Other Study ID Numbers	CV203-003
Has Data Monitoring Committee	No
Information Provided By	Bristol-Myers Squibb
Study Sponsor	Bristol-Myers Squibb
Collaborators	PRA International
Investigators	Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Verification Date	February 2011

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