Safety and Pharmacokinetics (PK) in Multidrug-Resistant (MDR) Refractive Tuberculosis

Summary

The purpose of this study is: * To evaluate the safety and tolerability of orally administered OPC-67683 when administered two times daily to MDR tuberculosis (TB) participants refractory to treatment with an optimized background regimen of anti-TB medications (OBR). * To evaluate the pharmacokinetics (PK) of OPC-67683 and metabolites.

Timeline

Start

2010-02-19

Primary completion

2011-05-12

Completion

2011-05-12

Outcome

Outcome not reported

Stopped (Enrollment): “The study was terminated early due to lack of efficacy after 10 participants enrolled.”

Drugs

Indications