VX-950HEP1001 - Drug-drug Interaction Study Between Telaprevir and Raltegravir

This is an open-label, randomized (the order in which you receive the treatment sessions is
determined by chance, like tossing a coin), crossover (participants will receive different
interventions sequentially during the trial) study in healthy participants to investigate
the effect of telaprevir 750 mg, every 8 hours, on the pharmacokinetics (how the drug is
absorbed into the bloodstream, distributed in the body and eliminated from the body) of
raltegravir 400 mg, twice a day, and vice versa. The study population will consist of 20
healthy participants. Each individual participant will receive two treatments: Treatment A
(telaprevir 750 mg, every 8 hours, alone, on Days 1 to 6, with a morning dose on Day 7) and
Treatment B (raltegravir 400 mg, twice a day, on Days 1 to 10 and telaprevir 750 mg, every 8
hours, on Days 5 to 10, with a morning dose of raltegravir, and a morning and afternoon dose
of telaprevir on Day 11). Half of the participants will receive first Treatment A and then
Treatment B; the other half will receive first Treatment B and then Treatment A. There will
be a washout period of at least 14 days between the 2 sessions. The screening period will be
maximum 21 days; the treatment duration will be approximately 4.5 weeks, and the follow-up
period will be 30 to 31 days. All study medication will be taken with food. On Day 7 of
Treatment A and Day 11 of Treatment B, 9 blood samples will be taken for determination of
the levels of telaprevir in the blood. On Days 4 and 11 of Treatment B, 10 blood samples
will be taken for determination of the levels of raltegravir in the blood. Predose
pharmacokinetic samples will be collected on other days during the treatment sessions.
Safety and tolerability will be evaluated throughout the trial by evaluating results of
blood and urine analyses, vital signs, physical examinations, electrocardiograms (electrical
recording of the heart), drug and alcohol screenings, and by assessing how the participant
is feeling. In Treatment A, participants will receive 2 oral tablets of telaprevir 375 mg
every 8 hours on Days 1 to 6, with a morning dose on Day 7. In Treatment B, participants
will receive 1 oral tablet of 400 mg raltegravir twice a day on Days 1 to 10 and 2 oral
tablets of 375 mg telaprevir every 8 hours on Days 5 to 10, with a morning dose of
raltegravir, and a morning and afternoon dose of telaprevir on Day 11.