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

NCT00946842 | Completed Phase 1

• 3 other identifiers: CR007504TMC207-TIDP13-C111TMC207-C111
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Keywords

Healthy; Bioavailability; Relative bioavailability; TMC207; Fed condition; Fasted condition

Outcome Measures

Primary Outcomes (3)

• Time to Reach the Maximum Plasma Concentration of TMC207

  0 hour predose to 672 hours postdose, after each of the 3 single-dose administration

• Maximum Plasma Concentration of TMC207

  0 hour predose to 672 hours postdose, after each of the 3 single-dose administration

• Area Under Curve From Time of Administration up to 72 Hours Post Dosing of TMC207

  0 hour predose to 672 hours postdose, after each of the 3 single-dose administration

Secondary Outcomes (8)

• Time to Reach the Maximum Plasma Concentration of M2 Metabolite of TMC207

  0 hour predose to 672 hours postdose, after each of the 3 single-dose administration

• Maximum Plasma Concentration of M2 Metabolite of TMC207

  0 hour predose to 672 hours postdose, after each of the 3 single-dose administration

• Area Under Curve From Time of Administration up to 72 Hours Post Dosing of M2 Metabolite of TMC207

  0 hour predose to 672 hours postdose, after each of the 3 single-dose administration

• Area Under Curve From Time of Administration up to the Last Time Point With a Measurable Concentration Post Dosing of M2 Metabolite of TMC207

  0 hour predose to 672 hours postdose, after each of the 3 single-dose administration

• Area Under Curve Extrapolated to Infinity of M2 Metabolite of TMC207

  0 hour predose to 672 hours postdose, after each of the 3 single-dose administration

Study Arms (12)

Panel A: Treatment Sequence ABC

EXPERIMENTAL

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.

Drug: Treatment A; Drug: Treatment B; Drug: Treatment C

Panel A: Treatment Sequence ACB

EXPERIMENTAL

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.

Drug: Treatment A; Drug: Treatment B; Drug: Treatment C

Panel A: Treatment Sequence BAC

EXPERIMENTAL

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.

Drug: Treatment A; Drug: Treatment B; Drug: Treatment C

Panel A: Treatment Sequence BCA

EXPERIMENTAL

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.

Drug: Treatment A; Drug: Treatment B; Drug: Treatment C

Panel A: Treatment Sequence CBA

EXPERIMENTAL

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.

Drug: Treatment A; Drug: Treatment B; Drug: Treatment C

Panel A: Treatment Sequence CAB

EXPERIMENTAL

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.

Drug: Treatment A; Drug: Treatment B; Drug: Treatment C

Panel B: Treatment Sequence DEF

EXPERIMENTAL

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.

Drug: Treatment D; Drug: Treatment E; Drug: Treatment F

Panel B: Treatment Sequence DFE

EXPERIMENTAL

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..

Drug: Treatment D; Drug: Treatment E; Drug: Treatment F

Panel B: Treatment Sequence EDF

EXPERIMENTAL

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.

Drug: Treatment D; Drug: Treatment E; Drug: Treatment F

Panel B: Treatment Sequence EFD

EXPERIMENTAL

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.

Drug: Treatment D; Drug: Treatment E; Drug: Treatment F

Panel B: Treatment Sequence FDE

EXPERIMENTAL

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.

Drug: Treatment D; Drug: Treatment E; Drug: Treatment F

Panel B: Treatment Sequence FED

EXPERIMENTAL

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.

Drug: Treatment D; Drug: Treatment E; Drug: Treatment F

Interventions

Treatment A 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.

Panel A: Treatment Sequence ABC; Panel A: Treatment Sequence ACB; Panel A: Treatment Sequence BAC; Panel A: Treatment Sequence BCA; Panel A: Treatment Sequence CAB; Panel A: Treatment Sequence CBA

Treatment B 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.

Panel A: Treatment Sequence ABC; Panel A: Treatment Sequence ACB; Panel A: Treatment Sequence BAC; Panel A: Treatment Sequence BCA; Panel A: Treatment Sequence CAB; Panel A: Treatment Sequence CBA

Treatment C 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 ABC; Panel A: Treatment Sequence ACB; Panel A: Treatment Sequence BAC; Panel A: Treatment Sequence BCA; Panel A: Treatment Sequence CAB; Panel A: Treatment Sequence CBA

Treatment D 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.

Panel B: Treatment Sequence DEF; Panel B: Treatment Sequence DFE; Panel B: Treatment Sequence EDF; Panel B: Treatment Sequence EFD; Panel B: Treatment Sequence FDE; Panel B: Treatment Sequence FED

Treatment E 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.

Panel B: Treatment Sequence DEF; Panel B: Treatment Sequence DFE; Panel B: Treatment Sequence EDF; Panel B: Treatment Sequence EFD; Panel B: Treatment Sequence FDE; Panel B: Treatment Sequence FED

Treatment F 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 DEF; Panel B: Treatment Sequence DFE; Panel B: Treatment Sequence EDF; Panel B: Treatment Sequence EFD; Panel B: Treatment Sequence FDE; Panel B: Treatment Sequence FED

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tibotec BVBA: lead

Study Officials

• Tibotec-Virco Virology BVBA Clinical Trial

  Tibotec BVBA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2009
• First Posted: July 27, 2009
• Study Start: August 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: March 19, 2013

Record last verified: 2013-03