Hepatitis C
Conditions
Brief summary
The primary purpose is to assess the effect of Daclatasvir (DCV)/Asunaprevir (ASV)/BMS-791325 combination therapy on the exposure of Rosuvastatin.
Detailed description
IND Number: 79,599/101,943 Primary Purpose: Other - Phase 1 Clinical Pharmacology drug interaction study in healthy subjects
Interventions
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Healthy subjects with no clinically significant deviations from normal in medical history, physical exam findings, 12 lead ECG measurements and clinical laboratory tests * Females must be of non-childbearing potential
Exclusion criteria
* Women of childbearing potential * Any significant acute or chronic medical condition * Inability to tolerate oral medications * Inability to be venipunctured and/or tolerate venous access * Abnormal liver function tests * Current or recent (within 3 months of dosing) gastrointestinal disease
Design outcomes
Primary
| Measure | 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) |
Secondary
| Measure | Time frame |
|---|---|
| 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 Rosuvastatin | Days 1 and 15 (predose through 96 hours) |
| 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 |
| 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 |
| Half life (T-HALF) of Rosuvastatin | Days 1 and 15 (predose through 96 hours) |
| Apparent total body clearance (CLT/F) of Rosuvastatin | Days 1 and 15 (predose through 96 hours) |
Outcome results
None listed