HIV Clinical Trial
Official title:
A Phase I, Open-label, Randomized Crossover Trial to Investigate the Pharmacokinetic Interaction Between Steady-state Lopinavir/Ritonavir and Single-dose TMC207 in Healthy Subjects.
The purpose of this Phase I, open-label, randomized crossover trial is to investigate the pharmacokinetic interaction between steady-state lopinavir/ritonavir and single-dose TMC207 in healthy volunteers.
TMC207 is being investigated for the treatment of MDR-TB infection. This is a Phase I,
open-label, randomized crossover trial in healthy volunteers to investigate the potential
interaction between steady-state lopinavir/ritonavir (LPV/rtv) 400/100 mg twice daily and a
single dose of 400 mg TMC207. The trial population will consist of 16 healthy volunteers.
During 2 sessions, each participant will receive 2 treatments (Treatments A and B) in a
randomized order. This means it will be decided by chance if subjects will receive first
treatment A, then B or first treatment B, then A.
In Treatment A, participants will receive a single dose of TMC207 400 mg on Day 1. In
Treatment B, participants will receive LPV/rtv 400/100 mg twice daily on Days 1 to 24, while
on Day 11 a single dose of TMC207 400 mg will be co-administered. The two single doses of
TMC207 will be administered 4 weeks apart. Consequently, Treatment B should start 4 days
after completion of Treatment A, and Treatment A should start 14 days after completion of
Treatment B (counting from the day the last PK sample has been collected). Pharmacokinetic
profiles over 336 hours will be determined for TMC207 and its N-monodesmethyl metabolite
(M2) after administration of TMC207 400 mg alone (Day 1 of Treatment A), and in combination
with steady-state LPV/rtv (Day 11 of Treatment B). Morning predose concentrations of
lopinavir and ritonavir will be determined at several time points. Safety and tolerability
will be evaluated throughout the trial. Day 1 of Treatment A and on Day 11 of Treatment B,
400 mg TMC207 (1 tablet) will be taken orally in the morning within 10 mins. after
completion of a meal. Days 1 to 24 of Treatment B, 2 tablets of Lopinavir/Ritonavir (LPV/rtv
= 400 mg lopinavir and 100 mg ritonavir) will be taken in the morning and evening. When
LPV/rtv is administered alone, it can be taken with or without food. When co-administered
simultaneously with TMC207, LPV/rtv intake will be within 10 mins. after completion of a
meal.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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