Safety, tolerability and effectiveness of TMC207 in combination with an individualized background regimen in MDR-TB (Multi-drug Resistant Tuberculosis) − To evaluate safety, tolerability, and efficacy of TMC207 as part of a multi-drug regimen in the treatment of subjects with MDR-TB; − To evaluate the pharmacokinetics of TMC207 and its primary metab...

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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 The primary objective is to assess the relative bioavailability of TMC207 after single-dose administration of 100 mg of TMC207 as water dispersible tablets or granules using a 100-mg tablet formulatio...

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A study to evaluate the efficacy and safety of TMC207 in patients with pulmonary infection with multi-drug resistant Mycobacterium tuberculosis The primary objective is to demonstrate that TMC207 added to a BR is superior to this BR plus placebo in regard to the proportion of subjects with favourable treatment outcome 60 weeks after randomiza...

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TMC207TBC3001 - Early Access of TMC207 in Patients with Extensively Drug Resistant (XDR) or Pre-XDR Pulmonary Tuberculosis (TB) The primary objective is to provide early access to TMC207 for subjects who have pulmonary infection due to strains of M. tuberculosis with resistance to INH, RMP, and to a fluoroquinolone (FQ) and/or...

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