Hepatitis C
Conditions
Brief summary
Assess the effect of renal function on the blood levels of DCV, ASV, BMS-791325.
Detailed description
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)
Interventions
DRUGDCV 3DAA FDC
DRUGBMS-791325
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Subjects in Group A must be in good health and have normal renal function * Subjects in Groups B-E may have clinical, Electrocardiogram (ECG) and laboratory findings consistent with their degree of renal dysfunction * Women of childbearing potential (WOCBP) and male participants must agree to follow the required contraceptive methods
Exclusion criteria
* Subjects in Group A must not have any significant acute or chronic illnesses * Subjects in Groups B-E must not have uncontrolled or unstable cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematopoietic, and/or neurological disease within 6 months of screening * Subjects in Groups B-E may not have evidence of rapidly deteriorating renal function, defined as a screening creatinine clearance (CLcr) which has decreased from a previous CLcr by 50% within the last 3 months * Prior exposure to DCV, ASV or BMS-791325 within 3 months prior to study drug administration
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13 | BMS-948158 may also be analyzed |
| AUC(TAU) fraction unbound (AUC(TAU) fu) 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 | BMS-948158 may also be analyzed |
| 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 | — |
| 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 | — |
| 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 | — |
| 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 | — |
| 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 | — |
Countries
United States
Outcome results
None listed