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.
Who can participate
Age range
18 Years – 64 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Provide written, informed consent prior to all trial-related procedures
. Male or female participants aged between 18 and 64 years, inclusive.
. Able to produce sputum for mycobacterium culture or able to obtain sputum produced through Induction.
. At least three sputum mycobacterium cultures positive for MTB with in-vitro resistance to isoniazid and rifampicin during the previous 270 days (9 months) despite treatment with first and second line anti-TB drugs, including one positive culture within the previous 60 days from the time of sputum collection, prior to date of screening initiation \[defined as the date the informed consent form (ICF) is signed and screening begins\].
. Sputum mycobacterial culture positive for MTB with in-vitro susceptibility to at least one anti-TB medication within the previous 60 days prior to the date of screening initiation.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Participants With Potentially Clinically Significant Abnormalities in Vital Signs
Timeframe: Up to approximately 40 weeks
2
Percentage of Participants With Potentially Clinically Significant Abnormalities in Electrocardiogram (ECG) Results
Timeframe: Up to approximately 40 weeks
3
Percentage of Participants With Potentially Clinically Significant Laboratory Values
Timeframe: Up to approximately 40 weeks
4
Percentage of Participants With Abnormal Audiometry Assessment Values
Timeframe: Up to approximately 40 weeks
5
Percentage of Participants With Abnormal Visual Acuity Assessment Values
Timeframe: Up to approximately 40 weeks
6
Percentage of Participants Taking Concomitant Anti-Tuberculosis (TB) Medication During the Trial
Timeframe: Up to approximately 40 weeks
7
Percentage of Participants Taking Concomitant (Excluding Anti-TB) Medication During the Trial
Trial details
NCT IDNCT01131351
SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.
. Participant judged by the investigator to have potential for clinical benefit from OPC-67683 exposure.
. Female participants 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 (to cover duration of ovulation).
. Male participant must agree to use an adequate method of contraception (double barrier) throughout the participation in the trial and for 30 weeks after last dose (to cover duration of spermatogenesis).
Exclusion criteria
. A history of allergy to any nitro-imidazoles or nitro-imidazole derivatives at any time.
. Use of the medications in Section 4.1 including: use of amiodarone at any time during the previous 12 months, use of other antiarrhythmics for the previous 30 days, as well as use of certain antidepressants, anti-histamines, any macrolides, for the previous 14 days.
. Any current serious concomitant conditions or renal impairment characterized by serum creatinine levels \~265 micromoles (μmol)/L or hepatic impairment characterized by alanine aminotransferase (ALT) and/or aspartate transferase (AST) levels 3 times the upper limit of the laboratory reference range.
. Current clinically relevant changes in the Screening electrocardiogram (ECG) such as any atrioventricular (AV) block, prolongation of the QRS complex over 120 msec (in both male and female participants), or of the QT interval with Fridericia's correction (QTcF) interval over 450 msec in male participants and over 470 msec in female participants.
. 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 participants with human immunodeficiency virus (HIV) infection, helper/inducer T-lymphocyte (CD4 cell) count \< 350/mm\^3 or on treatment with anti-retroviral medication for HIV infection.
. Karnofsky score \< 50%.
. Any current diseases or conditions in which the use of nitro-imidazoles or nitro-imidazole derivates is contra-indicated.
Timeframe: Up to approximately 40 weeks
8
Percentage of Participants With Adverse Events (AEs)
Timeframe: Up to approximately 40 weeks
9
Percentage of Participants With Immediately Reportable Events (IREs)
Timeframe: Up to approximately 40 weeks
10
Cmax: Maximal Peak Plasma Concentration for Delamanid
Timeframe: At 24 hours post dose on Days 1, 14, 28, 56, 112 and 196
11
Tmax: Time to Reach Maximal Peak Plasma Concentration for Delamanid
Timeframe: At 24 hours post dose on Days 1, 14, 28, 56, 112 and 196
12
AUC0-24h: Area Under the Plasma Concentration-Time Curve From 0 To 24 Hours for Delamanid
Timeframe: At 24 hours post dose on Days 1, 14, 28, 56, 112 and 196
13
Rac (Cmax): Ratio of Accumulation for Cmax of Delamanid
Timeframe: At 24 hours post dose on Days 1, 14, 28, 56, 112 and 196
14
Rac (AUC): Ratio of Accumulation for AUC of Delamanid
Timeframe: At 24 hours post dose on Days 1, 14, 28, 56, 112 and 196