Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary purpose is to assess the effect of Daclatasvir (DCV)/Asunaprevir (ASV)/BMS-791325 combination therapy on the exposure of Rosuvastatin.
IND Number: 79,599/101,943
Primary Purpose: Other - Phase 1 Clinical Pharmacology drug interaction study in healthy subjects
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: DCV/ASV/BMS-791325 FDC + BMS-791325 + Rosuvastatin | Experimental | Treatment A: Rosuvastatin tablet orally on specified days Treatment B: Daclatasvir, Asunaprevir and BMS-791325 Fixed dose combination (FDC) + BMS-791325 tablet orally on specified days Treatment C: Daclatasvir, Asunaprevir and BMS-791325 FDC + BMS-791325 + Rosuvastatin tablet orally on specified days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daclatasvir, Asunaprevir and BMS-791325 FDC | Drug |
| ||
| BMS-791325 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration (Cmax) of Rosuvastatin | Day 1 (predose) to Day 5 (96 hours) and Day 15 (predose) to Day 19 (96 hours) | |
| Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) of Rosuvastatin | Day 1 (predose) to Day 5 (96 hours) and Day 15 (predose) to Day 19 (96 hours) | |
| Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of Rosuvastatin | Day 1 (predose) to Day 5 (96 hours) and Day 15 (predose) to Day 19 (96 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Time of maximum observed concentration (Tmax) of Rosuvastatin | Days 1 and 15 (predose through 96 hours) | |
| Half life (T-HALF) of Rosuvastatin | Days 1 and 15 (predose through 96 hours) | |
Not provided
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol Myers Squibb | Bristol-Myers Squibb | Study Director |
Not provided
Not provided
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
Not provided
Not provided
| ID | Term |
|---|---|
| C549273 | daclatasvir |
| C571889 | asunaprevir |
| 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 |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
| Rosuvastatin | Drug |
|
|
| Apparent total body clearance (CLT/F) of Rosuvastatin |
| Days 1 and 15 (predose through 96 hours) |
| Maximum observed concentration (Cmax) of Daclatasvir, Asunaprevir and BMS-791325 and BMS-794712 | Day 15 (predose through 12 hours) and Days 13 and 14 pre-AM-dose |
| Trough observed plasma concentration (predose) (Ctrough) of Daclatasvir, Asunaprevir and BMS-791325 and BMS-794712 | Day 15 (predose through 12 hours) and Days 13 and 14 pre-AM-dose |
| Area under the concentration-time curve in one dosing interval [AUC(TAU)] of Daclatasvir, Asunaprevir and BMS-791325 and BMS-794712 | Day 15 (predose through 12 hours) and Days 13 and 14 pre-AM-dose |
| Time of maximum observed concentration (Tmax) of Daclatasvir, Asunaprevir and BMS-791325 and BMS-794712 | Day 15 (predose through 12 hours) and Days 13 and 14 pre-AM-dose |
| Observed plasma concentration at 12 hours after dosing in a pharmacokinetic (PK) profile (C12) of Daclatasvir, Asunaprevir and BMS-791325 and BMS-794712 | Day 15 (predose through 12 hours) and Days 13 and 14 pre-AM-dose |
| Safety measured by incidence of Adverse events (AEs), Serious adverse events (SAEs) and AEs leading to discontinuation | Days 1 through 19 |
| Safety measured by results of vital sign measurements, Electrocardiogram (ECGs), physical examinations and clinical laboratory tests | Days 1 through 19 |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |