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The purpose of this study is to determine the change from baseline in HCV Ribonucleic acid (RNA) on Day 4 following three days of dosing with BMS-929075 in chronically genotype subtype 1a and 1b HCV infected subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: BMS-929075 (≤ 25 mg) OR Placebo matching BMS-929075 | Experimental |
| |
| Arm 2: BMS-929075 (≤ 100 mg) OR Placebo matching BMS-929075 | Experimental |
| |
| Arm 3: BMS-929075 (≤ 400 mg) OR Placebo matching BMS-929075 | Experimental |
| |
| Arm 4: BMS-929075 (≤ 800 mg) OR Placebo matching BMS-929075 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-929075 | Drug | Oral Suspension, ≤ 25 mg, Once daily, 3 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| HCV RNA level on Day 4 | Within 4 days after the first dose |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum decrease from baseline in plasma HCV RNA levels during the period from Day 1 to Day 28 | Days 1-28 | |
| Time course of the change from baseline in plasma HCV RNA levels and the time of maximum decrease during the period of Day 1 through Day 28 | Days 1-28 |
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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 | Herston | Queensland | 4006 | Australia | ||
| Local Institution |
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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-929075 | Drug | Oral Suspension, ≤ 100 mg, Once daily, 3 days |
|
| BMS-929075 | Drug | Oral Suspension, ≤ 400 mg, Once daily, 3 days |
|
| BMS-929075 | Drug | Oral Suspension, (≤ 800 mg, Once daily) OR (≤ 400 mg, Twice daily), 3 days |
|
| Placebo matching BMS-929075 | Drug | Oral Suspension, 0 mg, Once daily, 3 days |
|
| Placebo matching BMS-929075 | Drug | Oral Suspension, 0 mg, (Once daily for ≤ 800 mg group) OR (Twice daily for ≤ 400 mg group), 3 days |
|
| Safety assessments will be based on medical review of adverse event reports and the results of vital sign measurements, ECGs, physical examinations, and clinical laboratory tests | Days 1-28 (with SAE from screening to Day 30) |
| Maximum observed plasma concentration (Cmax) of BMS-929075 derived from plasma concentration versus time | Day 1 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h), Day 2, and Day 3 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h,24h, 36h, 48h and 72h) |
| Minimum observed plasma concentration (Cmin) of BMS-929075 derived from plasma concentration versus time | Day 1 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h), Day 2, and Day 3 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h,24h, 36h, 48h and 72h) |
| Trough observed plasma concentration (Ctrough) of BMS-929075 derived from plasma concentration versus time | Day 1 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h), Day 2, and Day 3 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h,24h, 36h, 48h and 72h) |
| Time of maximum observed plasma concentration (Tmax) of BMS-929075 derived from plasma concentration versus time | Day 1 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h), Day 2, and Day 3 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h,24h, 36h, 48h and 72h) |
| Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-929075 derived from plasma concentration versus time | Day 1 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h), Day 2, and Day 3 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h,24h, 36h, 48h and 72h) |
| Plasma half-life (T-HALF) of BMS-929075 derived from plasma concentration versus time | Day 1 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h), Day 2, and Day 3 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h,24h, 36h, 48h and 72h) |
| Protein Binding (PB) of BMS-929075 derived from plasma concentration versus time | Day 3 (0h and 2h) |
| Fraction of free drug in plasma (fu) of BMS-929075 derived from plasma concentration versus time | Day 1 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h), Day 2, and Day 3 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h,24h, 36h, 48h and 72h) |
| The relationship between antiviral activity and measures of exposure to BMS-929075 | Days 1-6 |
| Adelaide |
| South Australia |
| 5000 |
| Australia |
| Local Institution | Melbourne | Victoria | 3004 | Australia |
| 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 |