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The primary purpose of this study is to evaluate the safety profile and tolerability of single oral doses of BMS-791325 in subjects with chronic hepatitis C infection
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | BMS-791325 (100 mg) or placebo match for (100 mg) |
|
| 2 | Experimental | BMS-791325 (300 mg) or placebo match for (300 mg) |
|
| 3 | Experimental | BMS-791325 (900 mg) or placebo match for (900 mg) |
|
| 4 | Experimental | BMS-791325 (potential dose between 10-800 mg) or placebo match for (10-800 mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-791325 | Drug | Capsules, 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 |
|---|---|---|---|---|---|---|
| Advanced Clinical Res Inst | Anaheim | California | 92801 | United States | ||
| West Coast Clinical Trials, Llc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24733462 | Derived | Sims KD, Lemm J, Eley T, Liu M, Berglind A, Sherman D, Lawitz E, Vutikullird AB, Tebas P, Gao M, Pasquinelli C, Grasela DM. Randomized, placebo-controlled, single-ascending-dose study of BMS-791325, a hepatitis C virus (HCV) NS5B polymerase inhibitor, in HCV genotype 1 infection. Antimicrob Agents Chemother. 2014 Jun;58(6):3496-503. doi: 10.1128/AAC.02579-13. Epub 2014 Apr 14. |
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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 |
|---|---|
| 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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| Placebo | Drug | Capsules, Oral, Once Daily, Single Dose |
|
| Cypress |
| California |
| 90630 |
| United States |
| Washington University School Of Medicine | St Louis | Missouri | 63110 | United States |
| University Of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Alamo Medical Research | San Antonio | Texas | 78215 | United States |
| Local Institution | Buenos Aires | Buenos Aires | C1181 | Argentina |
| 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 |