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| Name | Class |
|---|---|
| PRA Health Sciences | INDUSTRY |
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The purpose of this study is to assess the effects of diltiazem on the pharmacokinetics of single-dose BMS-914392 in healthy subjects.
Protocol designed to evaluate the potential for a drug-drug interaction
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A (BMS-914832) | Experimental |
| |
| Treatment B (BMS-914832 + diltiazem) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-914832 | Drug | Tablets, Oral, 30 mg, once, 1 day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of single dose of BMS-914393 derived from serial measurements of BMS-914392 plasma concentrations | Pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72, and 96 hours after dosing of BMS-914392 alone or in combination with diltiazem |
| 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 of BMS-914392 alone or in combination with diltiazem | |
| 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 |
|---|---|
| D004110 | Diltiazem |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Diltiazem | Drug | Tablets, Oral, 360 mg, once daily, 10 days |
|
| Daily |
| D013568 |
| Pathological Conditions, Signs and Symptoms |