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.
IND Number: 100,932/79,599/101,943 Primary Purpose: Other: Phase 1 clinical pharmacology bioavailability study to assess food effect
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
24
Fixed Dose Combination of Daclatasvir (DCV), Asunaprevir (ASV) and BMS-791325
Healthcare Discoveries, Llc D/B/A Icon Development Solutions
San Antonio, Texas, United States
Maximum observed plasma concentration (Cmax) of DCV, ASV and BMS-791325
Time frame: 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
Time frame: 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
Time frame: Day 1 to Day 13
Time of maximum observed plasma concentration (Tmax) for DCV, ASV and BMS-791325
Time frame: Day 1 to Day 13
Terminal plasma half life (T-HALF) for DCV, ASV and BMS-791325
Time frame: Day 1 to Day 13
AUC(0-T) for BMS-794712
Time frame: Day 1 to Day 13
AUC(INF) for BMS-794712
Time frame: Day 1 to Day 13
Cmax for BMS-794712
Time frame: Day 1 to Day 13
Tmax for BMS-794712
Time frame: Day 1 to Day 13
T-HALF for BMS-794712
Time frame: Day 1 to Day 13
Safety measured by incidence of adverse event (AEs), serious AEs (SAEs) and AEs leading to discontinuation
Time frame: Day 1 to Day 13
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Safety measured by abnormalities in vital sign measurements
Time frame: Day 1 to Day 13
Safety measured by findings on electrocardiograms (ECG) measurements and physical examinations
Time frame: Day 1 to Day 13
Safety measured by marked abnormalities in clinical laboratory test results
Time frame: Day 1 to Day 13