Safety and Efficacy Evaluation of 4-month Regimen of OPC-167832, Delamanid and Bedaquiline in Participants With Drug-Susceptible Pulmonary TB

  • STATUS
    Recruiting
  • End date
    Feb 26, 2024
  • participants needed
    120
  • sponsor
    Otsuka Pharmaceutical Development & Commercialization, Inc.
Updated on 26 July 2022

Summary

This trial will assess the safety and efficacy of OPC-167832 combined with Delamanid and Bedaquiline in subjects with DS-TB administered for 4 months compared to rifampin, isoniazid, ethambutol, pyrazinamide (RHEZ) administered for 6 months

Details
Condition Pulmonary TB
Treatment RHEZ, Delamanid + Bedaquiline + OPC-167832 10 mg, Delamanid + Bedaquiline + OPC-167832 30 mg, Delamanid + Bedaquiline + OPC-167832 90 mg
Clinical Study IdentifierNCT05221502
SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.
Last Modified on26 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Able to provide written, informed consent prior to initiation of any trial-related procedures or treatments, and able, in the opinion of the investigator, to comply with all the requirements of the trial
Male or female participants between 18 and 65 years of age (inclusive) at the screening visit
Body weight ≥ 35.0 kg at the screening visit
Newly diagnosed, rifampin and isoniazid susceptible (on the screening sample) pulmonary TB
Able to spontaneously produce sputum
Females of childbearing potential (FOCBP) must agree to use 2 different approved methods of birth control or remain abstinent throughout their participation in the trial and for 12 weeks after the last dose of IMP or dose of RHEZ
Male participants must agree to use 2 different approved methods of birth control or remain abstinent throughout their participation in the trial and for 12 weeks after the last dose of IMP or RHEZ

Exclusion Criteria

Participants are known or suspected of having resistance to rifampin, isoniazid, ethambutol, pyrazinamide, DLM, or BDQ either confirmed by the laboratory, or based on epidemiological history, at screening
Evidence of clinically significant metabolic (for example, including ongoing or current hypokalemia [ie, potassium <3.5 mEq/dL at screening]), gastrointestinal, neurological, psychiatric, endocrine or liver (eg, hepatitis B and C) disease; malignancy; or other abnormalities (other than the indication being studied)
History of, or current, clinically relevant cardiovascular disorder such as heart failure, coronary heart disease, uncontrolled hypertension, arrhythmia or symptom strongly suggestive of such a problem (for example, syncope or palpitations), tachyarrhythmia or status after myocardial infarction
Known bleeding disorders or family history of bleeding disorders
Any diseases or conditions in which the use of DLM, BDQ, OPC 167832, rifampin, isoniazid, pyrazinamide, or ethambutol is contraindicated
Any prior treatment for M tuberculosis within the past 2 years
Any treatment with a drug active against M tuberculosis (eg, quinolones) within the 3 months prior to screening
Clinical evidence of severe extrapulmonary TB (eg, miliary TB, abdominal TB, urogenital TB, osteoarthritic TB, TB meningitis)
Evidence of pulmonary silicosis, lung fibrosis, or other lung condition considered as severe by the investigator (other than TB). In particular, any underlying condition that could interfere with the assessment of x-ray images, sputum collection, or interpretation of sputum findings, or otherwise compromise the subject's participation in the trial
Any renal impairment characterized by creatinine clearance/estimated glomerular filtration rate (eGFR) of < 60 mL/min/1.73 m2, or hepatic impairment characterized by alanine transaminase or aspartate transaminase > 2.0 × upper limit of normal of the clinical laboratory reference range or bilirubin > 2.0 × upper limit of normal of the clinical laboratory reference range, at screening
Screening glucose (nonfasting) ≥ 200 mg/dL or glycosylated hemoglobin (HbA1c) ≥ 6.5%
QTcF > 450 msec in male participants (> 470 msec in female participants), atrioventricular block II or III, bi-fasicular block, at screening or current or history of clinically significant ventricular arrhythmias. Other ECG abnormalities, if considered clinically significant by the investigator
Participants receiving any of the prohibited medications (see Section 6.5.1) within the specified periods or who would be likely to require prohibited concomitant therapy during the trial
Female participants who are breast-feeding or who have a positive pregnancy test result prior to receiving the first dose of IMP or RHEZ on Day 1
Current history of significant drug and/or alcohol abuse that is likely to result in poor adherence to trial requirements or that would pose a risk to the participant's well-being during the course of the trial
History of current hepatitis or carriers of hepatitis B surface antigen (HBsAg) and/or anti hepatitis C virus (HCV)
Participants who test positive for cocaine or other drugs of abuse (excluding known prescription stimulants and other prescribed medications and marijuana) at screening are excluded. Detectable levels of alcohol, marijuana, barbiturates, or opiates in the drug screen are not exclusionary if, in the investigator's documented opinion, the participant does not meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for moderate to severe substance use disorder and the positive test does not signal a clinical condition that would impact the safety of the participant or interpretation of the trial results, and participation is agreed to by the medical monitor prior to treatment
History of having taken an investigational drug within 30 days preceding trial entry
A history of difficulty in donating blood
Donation of blood or plasma within 30 days prior to dosing
History of serious mental disorders that, in the opinion of the investigator, would exclude the participant from participating in this trial
Any known prior exposure to OPC-167832, DLM, or BDQ
Participants with significant medical comorbidities that in the opinion of the investigator, should not participate in the trial
Participants with Karnofsky score < 60 will be excluded from the trial
Participants testing positive for active severe acute respiratory syndrome coronavirus (SARS-CoV-2) infection at screening
Participants with HIV co infection not on a stable anti-retroviral regimen consisting of tenofovir, emtricitabine/ lamivudine, dolutegravir (ie > 3 months), or who have a detectable viral load, or who have a CD4 count < 350 cells/mm3 will be excluded from the trial
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