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| Name | Class |
|---|---|
| PRA Health Sciences | INDUSTRY |
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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.
Protocol designed to evaluate the potential for a drug-drug-interaction
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| metoprolol | Other | Treatment A |
|
| BMS-914392 + metoprolol | Experimental | Treatment B |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| metoprolol | Drug | Tablets, Oral, 200 mg, once, 1 day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of single dose of metoprolol derived from serial measurements of metoprolol plasma concentrations | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The effect of multiple doses of BMS-914392 on PR, QRS, RR, and QTc intervals derived from serial electrocardiograms (ECGs) | 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 | |
| Number of subjects with adverse events as a measure of safety and tolerability of BMS-914392 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pra International | Lenexa | Kansas | 66219 | United States |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D008790 | Metoprolol |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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| BMS-914392 |
| Drug |
Tablets, Oral, 60 mg, once daily, 7 days |
|
| Daily |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |