Pulmonary Multidrug-resistant Tuberculosis MedDRA version: 12.0 Level: LLT Classification code 10037440 Term: Pulmonary tuberculosis
Conditions
Interventions
Product Name: OPC-67683
Product Code: OPC-67683
Pharmaceutical Form: Tablet
INN or Proposed INN: not applicable
Current Sponsor code: OPC-67683
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of orally administered OPC-67683 when administered two times daily (BID) to MDR TB patients refractory to treatment with an optimized background regimen of anti-TB medications (OBR). To evaluate the pharmacokinetics (PK) of OPC-67683 and metabolites.;Secondary Objective: To determine the proportion of patients with sputum culture conversion. Sputum culture conversion is defined to occur at the time of the collection of a sputum specimen with mycobacterial culture negative for growth of MTB using the MGIT® (Mycobacteria Growth Indicator Tube) culture system followed by at least one additional sputum specimen negative for growth at least 28 days after the first specimen negative for growth and not followed by any sputum specimens positive for growth of MTB during the remainder of the 280-day (40-week) trial period. To monitor development of in vitro resistance to OPC-67683 among enrolled patients over the 196-day (28-week) Treatment Period of the trial.;Primary end point(s): Safety: Vital signs, ECGs, clinical laboratory assessments, and AEs. Pharmacokinetic: For OPC-67683, time to maximal peak plasma concentration (tmax), maximal peak plasma concentration (Cmax), area under the plasma concentration-time curve from 0 to 24 hours (AUC0-24h), ratios of accumulation for Cmax and AUC0-24h [Rac(Cmax) and Rac(AUC), Day 14, 28, 56, 112 or 196/Day 1]. | — |
Countries
Latvia, Lithuania
Outcome results
None listed