NCT00946842

A Study to Determine the Relative Oral Bioavailability of Single Dose Administration of TMC207, Under Fed and Fasted Conditions in Healthy Participants

A Phase I, Two-Panel, Open-Label, Randomized, 3-way Crossover Trial in Healthy Subjects to Determine the Relative Oral Bioavailability of TMC207 After Single Dose Administration of TMC207 100 mg as the Phase II Clinical Trial Tablet Formulation and as a Newly Developed Tablet Formulation, Under Fed and Fasted Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Tibotec BVBA · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the relative oral bioavailability (the extent to which a medication or other substance becomes available to the body as compared with another form of medication or other substance) of TMC207 after single-dose oral administration of the Phase II clinical study tablet formulation, and a newly developed tablet formulations, under fed (with food) and fasted (without food) conditions.

Detailed description

This is a 2-panel (2 groups), open-label (all people know the identity of the intervention), randomized (the study medication is assigned by chance), 3- way crossover (method used to switch participants from one treatment arm to another in a clinical study) study. The study consists of 3 phases including, the screening phase (less than or equal to 21 days before administration of study medication), treatment phase (84 days), and the follow-up phase (up to 30 to 35 days after the last blood sample in the last treatment session is collected). Approximately 24 healthy participants will be allocated to one of two panels: Panel A (participants will receive study medication under fed condition); and Panel B (participants will receive study medication under fasted condition). Participants in Panel A will be randomly assigned to 1 of 6 treatment sequences (Treatment sequences ABC, ACB, BAC, BCA, CBA, and CAB) to receive the following 3 formulations of TMC207 with food: Treatments A: the Phase II tablet formulation; Treatment B: newly developed tablet formulation with fine particle size distribution; and Treatment C: newly developed tablet formulation with coarse particle size distribution. Participants in Panel B will be randomly assigned to 1 of 6 treatment sequences (Treatment sequences DEF, DFE, EDF, EFD, FDE, and FED) to receive the following 3 formulations of TMC207 without food: Treatments D: the Phase II tablet formulation; Treatment E: newly developed tablet formulation with fine particle size distribution; and Treatment F: newly developed tablet formulation with coarse particle size distribution. Subsequent treatments will be separated by a period of 4 weeks. The total duration of the study for each participant will be approximately 20 weeks. Safety evaluations will include assessment of adverse events, clinical laboratory tests, vital signs, electrocardiogram, physical examination, and alcohol urine medicine screen which will be monitored throughout the study.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Treatment A	Participants will receive phase II clinical study tablet formulation of TMC207 100 mg as a single oral dose with food on Day 1, Day 30 and Day 58.
DRUG	Treatment B	Participants will receive newly developed tablet formulation with fine particle size distribution of TMC207 100 mg as a single oral dose with food on Day 1, Day 30 and Day 58.
DRUG	Treatment C	Participants will receive newly developed tablet formulation with coarse particle size distribution of TMC207 100 mg as a single oral dose with food on Day 1, Day 30 and Day 58.
DRUG	Treatment D	Participants will receive phase II clinical study tablet formulation of TMC207 100 mg as a single oral dose without food on Day 1, Day 30 and Day 58.
DRUG	Treatment E	Participants will receive newly developed tablet formulation with fine particle size distribution of TMC207 100 mg as a single oral dose without food on Day 1, Day 30 and Day 58.
DRUG	Treatment F	Participants will receive newly developed tablet formulation with coarse particle size distribution of TMC207 100 mg as a single oral dose without food on Day 1, Day 30 and Day 58

Timeline

• Start date: 2009-08-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2009-07-27
• Last updated: 2013-03-19