The purpose of this study is to evaluate the effect of steady-state concentrations of odalasvir (ODV), as a single agent or in combination with simeprevir (SMV), on the single-dose pharmacokinetics of dabigatran etexilate in healthy participants.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
15
Participants will receive dabigatran etexilate mesylate 75 mg, orally.
Participants will receive ODV 25 mg, orally.
Participants will receive SMV 75 mg, orally.
Unnamed facility
Tempe, Arizona, United States
Maximum Observed Analyte Concentration (Cmax) of Dabigatran
Cmax is the maximum observed analyte concentration.
Time frame: Day 1, 17 and 26 (predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16, 24, 48, and 72 hours post dose)
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) of Dabigatran
The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.
Time frame: Day 1, 17 and 26 (predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16, 24, 48, and 72 hours post dose)
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of Dabigatran
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(0-last) and C(last)/lambda(z); wherein AUC(0-last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
Time frame: Day 1, 17 and 26 (predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16, 24, 48, and 72 hours post dose)
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: Baseline, up to follow-up (Approximately 43 days)
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