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drugset / Trial / NCT01131351

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

NCT01131351 ↗

Phase 2 Terminated 10 enrolled Otsuka Pharmaceutical Development & Commercialization, Inc.
Non-randomizedSequentialOpen-labelTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Delamanid Small molecule 250 mg Oral
Subject Delamanid Small molecule 300 mg Oral

Indications

tuberculosis