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The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics following single oral and multiple oral doses BMS-791325 in healthy Japanese subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-791325 - Part A, Dose 1 | Experimental |
| |
| BMS-791325 - Part A, Dose 2 | Experimental |
| |
| BMS-791325 - Part A, Dose 3 | Experimental |
| |
| BMS-791325 - Part B, Dose 1 | Experimental |
| |
| BMS-791325 - Part B, Dose 2 | Experimental |
| |
| BMS-791325 - Part B, Dose 3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-791325 | Drug | Capsules, Oral, 300 mg, Single Dose, One day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety (adverse events, physical examinations, clinical labs, ECGs, vital signs) | From time of dose to up to 14 days after last dose |
| Measure | Description | Time Frame |
|---|---|---|
| To measure concentration of study drug following single and multiple doses | Within 48 or 72 hours postdose |
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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 |
|---|---|---|---|---|---|---|
| Local Institution | Cypress | California | 90630 | United States |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| C587012 | 8-cyclohexyl-N-((dimethylamino)sulfonyl)-1,1a,2,12b-tetrahydro-11-methoxy-1a-((3-methyl-3,8-diazabicyclo(3.2.1)oct-8-yl)carbonyl)cycloprop(d)indolo(2,1-a)(2)benzazepine-5-carboxamide |
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| BMS-791325 |
| Drug |
Capsules, Oral, 900 mg, Single Dose, One day |
|
| BMS-791325 | Drug | Capsules, Oral, ≤1200 mg, Single Dose, One day |
|
| BMS-791325 | Drug | Capsules, Oral, 300 mg, Every 12 hours, 14 days |
|
| BMS-791325 | Drug | Capsules, Oral, 900 mg, once daily 14 days |
|
| BMS-791325 | Drug | Capsules, Oral, ≤1200 mg, Every 12 hours or once daily, 14 days |
|
| Placebo | Drug | Capsules, Oral, Single Dose, One day |
|
| Placebo | Drug | Capsules, Oral, Every 12 hours, 14 days |
|
| Placebo | Drug | Capsules, Oral, Once Daily, 14 days |
|
| Placebo | Drug | Capsules, Oral, Every 12 hours or once daily, 14 days |
|
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |