The purpose of this study is to evaluate the relative bioavailability, safety, and tolerability of 3 new formulations of telaprevir relative to the Incivek 375-mg tablets.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
64
A single 1125-mg dose administered orally
A single 1125-mg dose administered orally
A single 1125-mg dose administered orally
Texas
Dallas, Texas, United States
Wisconsin
Madison, Wisconsin, United States
PK parameters: Maximum plasma concentration (Cmax), area under the concentration versus time curve (AUC) from time 0 to infinity (AUC0-∞)
Time frame: Up to 57 days
• PK parameters: Maximum plasma concentration (Cmax), area under the concentration versus time curve AUC from time 0 to last time point (AUC0-tlast)
Time frame: Up to 57 Days
The safety and tolerability of 3 oral formulations of telaprevir as assessed by adverse events, serious adverse events and results of clinical laboratory tests (serum chemistry, hematology, and urinalysis), vital signs, and 12-lead electrocardiograms
Time frame: Up to 57days
Time to reach Cmax after dosing (tmax) and terminal half-life (t1/2) of telaprevir
Time frame: Up to 57 Days
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A single 1125-mg dose administered orally