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A Phase 1/2, Active-controlled, Randomized, Open-label Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Multiple Oral Doses of OPC-167832 Tablets in Subjects With Uncomplicated, Smear-positive, Drug-susceptible Pulmonary Tuberculosis

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Trial Profile

A Phase 1/2, Active-controlled, Randomized, Open-label Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Multiple Oral Doses of OPC-167832 Tablets in Subjects With Uncomplicated, Smear-positive, Drug-susceptible Pulmonary Tuberculosis

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 23 Nov 2023

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At a glance

  • Drugs Delamanid (Primary) ; Quabodepistat (Primary) ; Bedaquiline; Ethambutol; Isoniazid; Pyrazinamide; Rifampicin
  • Indications Pulmonary tuberculosis
  • Focus Adverse reactions; Pharmacokinetics; Therapeutic Use
  • Sponsors Otsuka Pharmaceutical Development & Commercialization

    • Most Recent Events

    • 08 Sep 2023 Number of treatment arms increased from 8 to 9 by the addition of Active Comparator: Stage 2: RHEZ arm, specific doses are assigned for the stage 1 arms. The previous primary end-points have been replaced by 36 new efficacy, safety and pharmacokinetic primary end-points
    • 28 Jun 2022 Status changed from active, no longer recruiting to completed.
    • 20 May 2022 Planned End Date changed from 1 Apr 2022 to 1 Jun 2022.
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