None listed
Conditions
Interventions
-All participants will receive OPC-67683 (PI) + TBO (Optimized Base Treatment) for 26 consecutive weeks.
Patients will receive an initial dose of OPC-67683 of 100mg (2 tablets of 50mg) 2 times / da
With a dose adjustment option of 200mg (4 tablets of 50mg) 2 times / day, and must remain in the hospital for 2 more days. All doses should be given after eating food in the morning and at night.
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Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC),
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1) Provide written, informed consent prior to all trial-related procedures 2) Male or female patients aged between 18 and 64 years, inclusive, at the time of enrollment into the 242-07-204 trial. Patients who were 64 years at the time of 204 enrollment and who are now 65 years, are eligible for this trial. 3) Patients who have completed trial 242-07-204. 4) Patients judged by the investigator to have the potential for clinical benefit from OPC-67683 exposure. 5) Able to produce sputum for mycobacterial culture or able to obtain sputum produced through induction. 6) Female patients of childbearing potential must have a negative urine pregnancy test and agree to use a highly effective method of birth control (for example, two of the following precautions: tubal ligation, vaginal diaphragm, intrauterine device, oral contraceptives, contraceptive implant, combined hormonal patch, combined injectable contraceptive or depot-medroxyprogesterone acetate) throughout the participation in the trial and for 22 weeks after last dose. 7) Male patients must agree to use an adequate method of contraception (double barrier) throughout the participation in the trial and for 30weeks after last dose.
Exclusion criteria
Exclusion criteria: 1) More than 30 days have elapsed since the date of termination of the patient in the trial 242-07-204 or more than 30 days after the initiation of the trial at the investigator´s center, whichever date is the later. 2) History of allergy to any nitro-imidazoles or nitro-imidazole derivatives at any time. 3) Use of medications in Section 4.1 including: use of amiodarone at any time during the previous 12 months, use of other antiarrhythmic drugs during the past 30 days, and use of certain other medications, including certain antidepressants, antihistamines And macrolides, during the previous 14 days. 4) Any current severe concomitant condition or renal failure characterized by serum creatinine levels = 265 μmol / L or hepatic impairment characterized by ALT And / or aspartate transferase (AST) 3 times the upper limit of the reference range of the results of the screening laboratory. 5) Current relevant clinical ECG changes (between the assessment of day 56 of the 204 trial and the initial visit), such as any atrioventricular (AV) block, QRS complex over 120 msec (in both male and female patients), or The QTcF of more than 450mseg in male patients and 470mseg in female patients. 6) Current clinically relevant cardiovascular disorder, such as heart failure, coronary disease, artery disease, uncontrolled or poorly controlled hypertension, arrhythmia, Tachyarrhythmia or state after myocardial infarction.
Contacts
Public ContactJacqueline Zeuner
SYNEOS HEALTH PERU S.R.L.
Outcome results
None listed