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Assess the effect of renal function on the blood levels of DCV, ASV, BMS-791325.
IND Number: 79,599/101,943
Primary Purpose: Other - Phase 1 Clinical Pharmacology study to determine the effect of renal impairment on the exposure of DCV, ASV, BMS-791325 (fixed dosed combination) and BMS-791325 given in multiple doses
Fixed dose combination (FDC)
Fixed Dose Combination of Daclatasvir, Asunaprevir and BMS-791325 (DCV 3DAA FDC)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DCV 3DAA FDC + BMS-791325 | Experimental | Group A to D: DCV 3DAA FDC + BMS-791325 oral tablets on specific days Group E: DCV 3DAA FDC + BMS-791325 oral tablets on specific days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DCV 3DAA FDC | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) for DCV, ASV, BMS-791325 and BMS-794712 | For Groups A-D: Day 1 to Day 10 and for Group E: Day 1 to Day 12 | |
| Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) for DCV, ASV, BMS-791325 and BMS-794712 | For Groups A-D: Day 1 to Day 10 and for Group E: Day 1 to Day 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration at 12 hours (C12) for (DCV, ASV, BMS-791325) and BMS-948158 | For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13 | |
| Time of maximum observed concentration (Tmax) for (DCV, ASV, BMS-791325) and BMS-948158 | For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13 |
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
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 |
|---|---|---|---|---|---|---|
| Clinical Pharmacology Of Miami Inc. | Miami | Florida | 33014 | United States | ||
| Orlando Clinical Research Center |
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| BMS-791325 |
| Drug |
|
| Apparent total body clearance (CLT/F) for (DCV, ASV and BMS-791325 only) | For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13 |
| Trough observed plasma concentration (Ctrough) for (DCV, ASV, BMS-791325), BMS-794712 and BMS-948158 | For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13 |
| Cmax fraction unbound (Cmaxfu) for (DCV, ASV, BMS-791325), BMS-794712 and BMS-948158 | BMS-948158 may also be analyzed | For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13 |
| AUC(TAU) fraction unbound (AUC(TAU) fu) for (DCV, ASV, BMS-791325), BMS-794712 and BMS-948158 | BMS-948158 may also be analyzed | For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13 |
| Protein Binding for DCV, ASV, BMS-791325 and BMS-794712 | 1 and 4 hours postdose on Day 10 (all subjects) and Day 12 (Group E only) |
| Total amount recovered in urine (URt) for (DCV, ASV, BMS-791325) and BMS-794712 | For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13 |
| Total percent of administered dose recovered in urine (%URt) for (DCV, ASV, and BMS-791325 only) | For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13 |
| Renal clearance (CLR) for DCV, ASV, BMS-791325, and BMS-794712 | For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13 |
| Maximum observed concentration (Cmax) for BMS-948158 | For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13 |
| Area under the concentration-time curve in 1 dosing interval (AUC (TAU)) for BMS-948158 | For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13 |
| Safety based on occurrence of Adverse Event (AEs), Serious adverse event (SAEs) and AEs leading to discontinuation | For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13 |
| Safety based on abnormalities in vital sign measurements | For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13 |
| Safety based on findings on ECG measurements and physical examinations | For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13 |
| Safety based on Marked abnormalities in clinical laboratory test findings | For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13 |
| Orlando |
| Florida |
| 32809 |
| United States |
| Davita Clinical Research | Minneapolis | Minnesota | 55404 | United States |
| New Orleans Center For Clinical Research - Knoxville | Knoxville | Tennessee | 37920 | United States |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| 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 |
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