NCT01803373

A Study to Assess the Relative Bioavailability of TMC207 Following Single-Dose Administrations of Two Pediatric Formulations in Healthy Adult Participants

A Phase I, Open-label, Randomized, 3-way Crossover Study in 3 Panels of Healthy, Adult Subjects to Assess the Relative Bioavailability of TMC207 Following Single-dose Administration of Two Pediatric Formulations Using a 100 mg Tablet Formulation as the Reference, With and Without Food.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Janssen Infectious Diseases BVBA · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to test the relative bioavailability (extent and rate to which a drug is taken up by the body) of TMC207 following the administration of two pediatric formulations of TMC207 taken with and without food in healthy adult participants.

Detailed description

This is an open-label (all study staff and participants know the identity of treatments assigned), 3-way cross-over (method used to switch participants from one treatment to another treatment) study. Three panels of 12 healthy adult participants each will be enrolled. Within each panel, participants will be randomly (by chance) assigned to 1 of 6 treatment sequences to receive each of the 3 formulations of TMC207 in a randomized order. The 3 formulations of TMC207 will be referred to as Treatments A, B, and C. In Treatment A, participants will receive a single 100-mg dose of TMC207 formulated as a 100-mg tablet (reference formulation). In Treatment B, participants will receive a single 100-mg dose of TMC207 formulated as 20-mg water dispersible (dissolvable) tablets (i.e. 5 tablets) (pediatric formulation 1). In Treatment C, participants will receive a single 100-mg dose of TMC207 formulated as granules 5 grams (20 mg/g) (pediatric formulation 2). Each treatment will be separated by 4 weeks. Participants in Panel 1 will receive each treatment with a standardized breakfast, Panel 2 will receive each treatment with yogurt, and Panel 3 will receive each treatment after a 10-hour overnight fast (without food). The duration of the treatment period in this study will be 8.5 weeks (includes 4 weeks between treatments).

Conditions

• Healthy
• Biological Availability

Interventions

Type	Name	Description
DRUG	Treatment A (reference)	One tablet equivalent to a single 100-mg dose of TMC207 taken orally (by mouth) once.
DRUG	Treatment B	Five 20-mg water dispersable tablets equivalent to a single 100-mg dose of TMC207 taken orally (by mouth) once.
DRUG	Treatment C	5 grams (ie,20mg/g) equivalent to a single 100-mg dose of TMC207 taken orally (by mouth) once.

Timeline

• Start date: 2013-04-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2013-03-04
• Last updated: 2014-03-18

Locations

1 site across 1 country: Netherlands