NCT01336829

TMC125IFD1001 - Drug-Drug Interaction of Etravirine With Telaprevir and TMC278 With Telaprevir.

A Phase I, Open Label, Randomized, 2-Panel, 2-Way Crossover Trial to Investigate the Pharmacokinetic Interaction Between Etravirine or TMC278 and Telaprevir at Steady-State in Healthy Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Tibotec Pharmaceuticals, Ireland · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to see the effect of etravirine or TMC278 on how telaprevir is absorbed into the body and the effect of telaprevir on how etravirine or TMC278 are absorbed into the body when administered together.

Detailed description

This is an open-label, randomized, single-dose, crossover trial in healthy volunteers. Crossover means that participants may receive different interventions sequentially during the trial. Randomized means that you will be assigned to a treatment sequence by chance, like flipping a coin. Open-label means that you and your physician will know what treatment you will receive. The study will consist of 3 phases: a screening phase, a treatment phase and a follow-up phase. Total study duration for an individual participant will be approximately 11 weeks. Once found eligible after the screening phase, participants will take part in one of the two parts of the treatment phase. In the first part, a group of 16 participants will receive two treatment sessions, A and B. The order in which the treatments are given will be determined by chance. In treatment A, 200 mg (2 tablets) ETR (etravirine) will be given twice a day from day 1 to 10 with a morning dose only on day 11. In treatment B, 750 mg (2 tablets) TVR (telaprevir) will be given from day 1 to 17 every 8 hours with a morning and afternoon dose only on day 18 and 200 mg ETR will be given twice a day from day 8 to 17 with a morning dose on day 18. In between the 2 sessions, there will be at least 14 days. In the second part, another group of 16 participants will receive 2 treatment sessions, C and D. The order in which these treatments are given will be determined by chance. In treatment C, 25 mg (1 tablet) TMC278 will be given once a day from day 1 to 11. In treatment D, 750 mg (2 tablets) TVR (telaprevir) will be given from day 1 to 18 every 8 hours and 25 mg TMC278 will be given once a day from day 8 to 18. In between the 2 sessions, there will be at least 14 days. All treatments will be taken food. In treatments A and C, participants will come to the unit the day before dosing and in the mornings of day 1, 9 and 10 and for a whole day on day 11. Only in treatment C, overnight stay from day 11 to day 12 is foreseen. In treatment B, participants will come to the unit the day before dosing and in the mornings of days 1, 5, 6, 8, 16 and 17 and for a whole day on days 7 and 18. In treatment D, participants will come to the unit the day before dosing and in the mornings of days 1, 5, 6, 8, 12, 16 and 17 and for a whole day on days 7 and 18 with overnight stay from day 18 to 19. Five to 7 days after last dosing, participants will have a last follow-up visit at the unit (follow-up phase). During the study, safety will be monitored, and during the treatment phase, at specified timepoints, blood samples will be taken for pharmacokinetic evalutions (effect of the body on the drugs). In treatment A, 2 tablets ETR will be given twice a day from day 1 to 10 with a morning dose on day 11. In treatment B, 2 tablets TVR will be given every 8 hours from day 1 to17 with only 2 doses on day 18 and 2 tablets ETR twice a day from day 8 to 17 with a morning dose only on day 18. In treatment C, 1 tablet TMC278 will be given oncy a day from day 1 to 11. In treatment D, 2 tablets of TVR will be given every 8 hours from day 1 to 18 and 1 tablet TMC278 once a day from day 8 to 18.

Conditions

• Hepatitis C
• HIV

Interventions

Type	Name	Description
DRUG	ETR/telaprevir	Treatment A: ETR 200 mg twice a day from Day 1 to Day 10 + a single dose in the morning on Day 11. Treatment B: telaprevir 750 mg every 8 hours from Day 1 to Day 17 + 2 doses (morning and afternoon) on Day 18, and ETR 200 mg twice a day from Day 8 to Day 17 + a single dose in the morning on Day 18.
DRUG	TMC278/telaprevir	Treatment C: TMC278 25 mg once day from Day 1 to Day 11. Treatment D: telaprevir 750 mg every 8 hours from Day 1 to Day 18, and TMC278 25 mg once daily from Day 8 to Day 18.
DRUG	telaprevir/ETR	Treatment A: ETR 200 mg twice a day from Day 1 to Day 10 + a single dose in the morning on Day 11. Treatment B: telaprevir 750 mg every 8 hours from Day 1 to Day 17 + 2 doses (morning and afternoon) on Day 18, and ETR 200 mg twice a day from Day 8 to Day 17 + a single dose in the morning on Day 18.
DRUG	telaprevir/TMC278	Treatment C: TMC278 25 mg once day from Day 1 to Day 11. Treatment D: telaprevir 750 mg every 8 hours from Day 1 to Day 18, and TMC278 25 mg once daily from Day 8 to Day 18.

Timeline

• Start date: 2011-03-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2011-04-18
• Last updated: 2012-08-29

Locations

1 site across 1 country: Belgium