A Phase 2, Multi-center, Non-controlled, Open-label Dose Escalation Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of Orally Administered OPC-67683 Two Times Daily to Patients with Pulmonary Multidrug-Resistant TuberculosisRefractory to Conventional Treatment.

Conditions: Pulmonary Multidrug-resistant Tuberculosis
MedDRA version: 12.0Level: LLTClassification code 10037440Term: Pulmonary tuberculosis

Registration Number: EUCTR2009-014944-13-LV

Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

Patients with at least three sputum mycobacterial cultures
positive for MTB with in vitro resistance to isoniazid and
rifampicin collected at separate timepoints during the
previous 270 days (9 months) despite treatment with first
and second-line anti-TB drugs, including one culture
within the previous 60 days prior to date of screening
initiation.

Patients with sputum mycobacterial culture positive for
MTB with in vitro susceptibility to at least one anti-TB
medication within the previous 60 days prior to date of
screening initiation.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A history of allergy to any nitro-imidazoles or nitroimidazole
derivates.

Prohibited medications: use of amiodarone for the
previous 12 months, use of other anti-arrhthymics for the
previous 30 days, and use of certain other medications,
including certain anti-depressants, anti-histamines, and
macrolides, for the previous 14 days.

Current clinically relevant changes in the screening ECG
such as any atrioventricular (AV) block, prolongation of
the QRS complex over 120 milliseconds (in both male and
female patients), or of QTcF interval over 450
milliseconds in male patients and over 470 milliseconds in
female patients.

Current clinically relevant cardiovascular disorder such as
heart failure, coronary heart disease, uncontrolled or
poorly controlled hypertension, arrhythmia,
tachyarrhythmia or status after myocardial infarction.

For patients with HIV infection, CD4 cell count <
350/mm3 or on treatment with anti-retroviral medication
for HIV infection.