The purpose of this study is to evaluate the effect that telaprevir has on the pharmacokinetics of cyclosporine and tacrolimus. Pharmacokinetics means how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
20
Tablet, Oral, 750mg, every 8 hours, Day 1-11 of Period 2
Tablet, Oral, 750mg, every 8 hours, Day 1-13 of Period 2
Solution, Oral, 100mg, Day 1 of Period 1
Unnamed facility
Dallas, Texas, United States
Part A only: Pharmacokinetic parameters of cyclosporine (Cmax, AUC0-tlast, AUC0-inf, tmax, t1/2)
Time frame: 33 days
Part A and Part B: Pharmacokinetic parameters of telaprevir (Cmax, AUC0-8h, Cmin, tmax)
Time frame: 33 days for Part A; 44 days for Part B
Part B only: Pharmacokinetic parameters of tacrolimus (Cmax, AUC0-tlast, AUC0-inf, tmax, t1/2)
Time frame: 44 days
Part A and Part B: Safety and tolerability as measured by adverse events, clinical laboratory assessments, electrocardiograms, vital signs, physical examinations
Time frame: 33 days for Part A; 44 days for Part B
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Solution, Oral, 10mg, Day 1 and Day 8 of Period 2
Capsule, Oral, 2mg, Day 1 of Period 1
Capsule, Oral, 0.5mg, Day 8 of Period 2