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

NCT ID: NCT00946842

Last Updated: 2013-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2010-03-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Panel A: Treatment Sequence ABC

Participants will receive the 3 treatments (Treatment A,B and C) in sequence ABC with food and subsequent treatments will be separated by 4 weeks.

Group Type: EXPERIMENTAL

Treatment A

Intervention Type: DRUG

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.

Treatment B

Intervention Type: DRUG

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.

Treatment C

Intervention Type: DRUG

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.

Panel A: Treatment Sequence ACB

Participants will receive the 3 treatments (Treatment A,B and C) in sequence ACB with food and subsequent treatments will be separated by 4 weeks.

Group Type: EXPERIMENTAL

Treatment A

Intervention Type: DRUG

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.

Treatment B

Intervention Type: DRUG

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.

Treatment C

Intervention Type: DRUG

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.

Panel A: Treatment Sequence BAC

Participants will receive the 3 treatments (Treatment A,B and C) in sequence BAC with food and subsequent treatments will be separated by 4 weeks.

Group Type: EXPERIMENTAL

Treatment A

Intervention Type: DRUG

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.

Treatment B

Intervention Type: DRUG

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.

Treatment C

Intervention Type: DRUG

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.

Panel A: Treatment Sequence BCA

Participants will receive the 3 treatments (Treatment A,B and C) in sequence BCA with food and subsequent treatments will be separated by 4 weeks.

Group Type: EXPERIMENTAL

Treatment A

Intervention Type: DRUG

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.

Treatment B

Intervention Type: DRUG

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.

Treatment C

Intervention Type: DRUG

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.

Panel A: Treatment Sequence CBA

Participants will receive the 3 treatments (Treatment A,B and C) in sequence CBA with food and subsequent treatments will be separated by 4 weeks.

Group Type: EXPERIMENTAL

Treatment A

Intervention Type: DRUG

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.

Treatment B

Intervention Type: DRUG

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.

Treatment C

Intervention Type: DRUG

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.

Panel A: Treatment Sequence CAB

Participants will receive the 3 treatments (Treatment A,B and C) in sequence CAB with food and subsequent treatments will be separated by 4 weeks.

Group Type: EXPERIMENTAL

Treatment A

Intervention Type: DRUG

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.

Treatment B

Intervention Type: DRUG

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.

Treatment C

Intervention Type: DRUG

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.

Panel B: Treatment Sequence DEF

Participants will receive the 3 treatments (Treatment D,E and F) in sequence DEF with food and subsequent treatments will be separated by 4 weeks.

Group Type: EXPERIMENTAL

Treatment D

Intervention Type: DRUG

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.

Treatment E

Intervention Type: DRUG

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.

Treatment F

Intervention Type: DRUG

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

Panel B: Treatment Sequence DFE

Participants will receive the 3 treatments (Treatment D,E and F) in sequence DFE with food and subsequent treatments will be separated by 4 weeks..

Group Type: EXPERIMENTAL

Treatment D

Intervention Type: DRUG

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.

Treatment E

Intervention Type: DRUG

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.

Treatment F

Intervention Type: DRUG

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

Panel B: Treatment Sequence EDF

Participants will receive the 3 treatments (Treatment D,E and F) in sequence EDF with food and subsequent treatments will be separated by 4 weeks.

Group Type: EXPERIMENTAL

Treatment D

Intervention Type: DRUG

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.

Treatment E

Intervention Type: DRUG

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.

Treatment F

Intervention Type: DRUG

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

Panel B: Treatment Sequence EFD

Participants will receive the 3 treatments (Treatment D,E and F) in sequence EFD with food and subsequent treatments will be separated by 4 weeks.

Group Type: EXPERIMENTAL

Treatment D

Intervention Type: DRUG

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.

Treatment E

Intervention Type: DRUG

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.

Treatment F

Intervention Type: DRUG

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

Panel B: Treatment Sequence FDE

Participants will receive the 3 treatments (Treatment D,E and F) in sequence FDE with food and subsequent treatments will be separated by 4 weeks.

Group Type: EXPERIMENTAL

Treatment D

Intervention Type: DRUG

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.

Treatment E

Intervention Type: DRUG

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.

Treatment F

Intervention Type: DRUG

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

Panel B: Treatment Sequence FED

Participants will receive the 3 treatments (Treatment D,E and F) in sequence FED with food and subsequent treatments will be separated by 4 weeks.

Group Type: EXPERIMENTAL

Treatment D

Intervention Type: DRUG

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.

Treatment E

Intervention Type: DRUG

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.

Treatment F

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Non-smoker or smokers with no more than 10 cigarettes or 2 cigars or 2 pipes per day for at least 3 months prior selection
• Normal weight as defined by a body mass index (weight in kilograms divided by the square of height in meters) of 18 to 30 kg/m2, extremes included
• Healthy on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality

Exclusion Criteria

• Positive tests for Human Immunodeficiency Virus 1 (HIV type 1) or HIV 2; hepatitis A, hepatitis B, or hepatitis C infection; and urine drug tests at screening
• Female with no childbearing potential
• History or current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use
• Relevant medical history or presence of systemic disease (gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory, infectious disease), or significant skin disease
• History or presence of clinically significant electrocardiogram at screening
• Abnormal laboratory values at screening

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tibotec BVBA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tibotec-Virco Virology BVBA Clinical Trial

Role: STUDY_DIRECTOR

Tibotec BVBA

Other Identifiers

TMC207-TIDP13-C111

Identifier Type: OTHER

Identifier Source: secondary_id

TMC207-C111

Identifier Type: OTHER

Identifier Source: secondary_id

CR007504

Identifier Type: -

Identifier Source: org_study_id