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The purpose of this study is to determine the antiviral effect following three days of dosing with BMS-824393 in chronically genotype subtype 1a and 1b Hepatitis C virus (HCV) infected subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-824393 (Panel 1) | Experimental |
| |
| BMS-824393 (Panel 2) | Experimental |
| |
| BMS-824393 (Panel 3) | Experimental |
| |
| BMS-824393 (Panel 4) | Experimental |
| |
| BMS-824393 (Panel 5) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-824393 | Drug | Capsule, Oral, 50mg, Once Daily, 3 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in HCV RNA following three days of dosing with BMS-824393 in chronically genotype subtype 1a and 1b HCV infected subjects | On Days 1, 2, 3, 4, 5, 6, 7, 14, 28, 90 and 180 days after study drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the change in HCV RNA over time during three days of dosing with BMS- 824393 and during the follow-up period in chronically genotype subtype 1a and 1b HCV infected subjects | On Days 1, 2, 3, 4, 5, 6, 7, 14, 28, 90 and 180 days after study drug administration | |
| To assess potential differences in antiviral effect in genotype subtypes (1a versus 1b) |
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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 |
|---|---|---|---|---|---|---|
| Advanced Clinical Research Institute | Anaheim | California | 92801 | United States | ||
| West Coast Clinical Trials, Llc |
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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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| BMS-824393 |
| Drug |
Capsule, Oral, 100mg, Once Daily, 3 days |
|
| BMS-824393 | Drug | Capsule, Oral, 10mg, Once Daily, 3 days |
|
| BMS-824393 | Drug | Capsule. Oral, 1mg, Once Daily, 3 days |
|
| BMS-824393 | Drug | Capsule, Oral, Flexible, ≤100mg, Once Daily, 3 days |
|
| On Days 1, 2, 3, 4, 5, 6, 7, 14, 28, 90 and 180 days after study drug administration |
| To assess the safety and tolerability of multiple oral doses of BMS-824393 | On Days 1, 2, 3, 4, 5, 6, 7, 14, 28, 90 and 180 days after study drug administration |
| Cypress |
| California |
| 90630 |
| United States |
| Elite Research Institute | Miami | Florida | 33169 | United States |
| Orlando Clinical Research Center | Orlando | Florida | 32809 | United States |
| Parexel International - Baltimore Epcu | Baltimore | Maryland | 21225 | 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 |