Conditions: Tuberculosis
Keywords: MDR-TB Dose Escalation Phase II Open Label Non Controlled Pulmonary Multidrug-Resistant Tuberculosis (MDR TB)
Allocation: NON_RANDOMIZED | Intervention model: SEQUENTIAL
Enrollment: 10
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Participants received delamanid five 50 milligrams (mg) (250 mg) tablets, twice a day (BID), along with at least 2 additional anti-TB medications per optimized background regimen (OBR) for up to 28 weeks. arm 2: Participants received delamanid six 50 mg (300 mg) tablets, BID, along with at least 2 additional anti-TB medications per OBR for up to 28 weeks.

Interventions: intervention 1: Delamanid intervention 2: Optimized Background Regimen (OBR)
Intervention descriptions: intervention 1: OPC-67683 film-coated tablets intervention 2: OBR was selected at the discretion of the study investigator and included at least 2 anti-TB medications based on World Health Organization (WHO's) guidelines for the programmatic management of drug-resistant TB. Study investigator could change OBR for a participant based on his/her tolerability and drug susceptibility testing (DST) results.

Protocol document: