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. |
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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 |
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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 |
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Descriptive Information[ + expand ][ + ]
Brief Title | Effect of BMS-914392 on Pharmacokinetics of Metoprolol |
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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) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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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 |
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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 |
Locations[ + expand ][ + ]
Pra International | Lenexa, Kansas, United States, 66219 |
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