Hepatitis C
Conditions
Brief summary
The purpose of this study is to assess the effect of a high fat meal and light meal on the blood levels of Daclatasvir, Asunaprevir and BMS-791325 after administration of the 3 drugs as a fixed-dose combination in healthy subjects.
Detailed description
IND Number: 100,932/79,599/101,943 Primary Purpose: Other: Phase 1 clinical pharmacology bioavailability study to assess food effect
Interventions
DRUGDCV 3DAA FDC
Fixed Dose Combination of Daclatasvir (DCV), Asunaprevir (ASV) and BMS-791325
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Healthy male and female subjects ages 18 to 49 years, inclusive. * Women of childbearing potential must be using an acceptable method of contraception for at least 4 weeks prior to study drug administration.
Exclusion criteria
* Any significant acute or chronic medical illness * Current or recent (within 3 months of study drug administration) gastrointestinal disease * Any gastrointestinal surgery that could impact upon the absorption of study drug, including cholecystectomy * History of biliary disorders, including Gilbert's syndrome or Dubin-Johnson disease * Use of tobacco-containing or nicotine-containing products * Any of the following on 12-lead electrocardiogram (ECG) prior to study drug administration, confirmed by repeat: * PR ≥210 msec * QRS ≥120 msec * QT ≥500 msec * QTcF ≥450 msec * Any of the following laboratory results outside of the ranges specified below prior to study drug administration, confirmed by repeat: * Alanine aminotransferase (ALT) \>Upper limit of normal (ULN) * Aspartate aminotransferase (AST) \>ULN * Total bilirubin (TBILI) \>ULN * Creatinine \>ULN
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum observed plasma concentration (Cmax) of DCV, ASV and BMS-791325 | Day 1 to Day 13 |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of DCV, ASV and BMS-791325 | Day 1 to Day 13 |
Secondary
| Measure | Time frame |
|---|---|
| Terminal plasma half life (T-HALF) for DCV, ASV and BMS-791325 | Day 1 to Day 13 |
| AUC(0-T) for BMS-794712 | Day 1 to Day 13 |
| AUC(INF) for BMS-794712 | Day 1 to Day 13 |
| Cmax for BMS-794712 | Day 1 to Day 13 |
| Tmax for BMS-794712 | Day 1 to Day 13 |
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] for DCV, ASV and BMS-791325 | Day 1 to Day 13 |
| Safety measured by incidence of adverse event (AEs), serious AEs (SAEs) and AEs leading to discontinuation | Day 1 to Day 13 |
| Safety measured by abnormalities in vital sign measurements | Day 1 to Day 13 |
| Safety measured by findings on electrocardiograms (ECG) measurements and physical examinations | Day 1 to Day 13 |
| Safety measured by marked abnormalities in clinical laboratory test results | Day 1 to Day 13 |
| T-HALF for BMS-794712 | Day 1 to Day 13 |
| Time of maximum observed plasma concentration (Tmax) for DCV, ASV and BMS-791325 | Day 1 to Day 13 |
Countries
United States
Outcome results
None listed