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The primary purpose of this study is to evaluate the safety profile and tolerability of single oral doses of BMS-650032 in subjects with chronic hepatitis C infection
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| or Placebo - Dose Panel 1 | Experimental | Oral Suspension, 10 mg |
|
| or Placebo - Dose Panel 2 | Experimental | Oral Suspension 50 mg |
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| or Placebo - Dose Panel 3 | Experimental | Oral Suspension, 200 mg |
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| or Placebo - Dose Panel 4 | Experimental | Oral Suspension or Solution, 2.5 to 600 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-650032 or Placebo | Drug | Oral, Once daily, Single Dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety Outcome Measures | Safety and tolerability assessments will be performed for a period of 7 days after administration of a single dose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Measures | Pharmacokinetic assessments will be done for a period of 72 hours following administration of a single oral dose | |
| Pharmacodynamic Measures | Antiviral activity will be assessed by the magnitude and rate of change in plasma HCV RNA levels for a period of 7 days after dosing |
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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 |
|---|---|---|---|---|---|---|
| West Coast Clinical Trials, Llc | Cypress | California | 90630 | United States | ||
| Orlando Clinical Research Center |
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C571889 | asunaprevir |
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| Orlando |
| Florida |
| 32809 |
| United States |
| Parexel International Corporation | Baltimore | Maryland | 21225 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Alamo Medical Research | San Antonio | Texas | 78215 | United States |
| D006525 |
| Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |