Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

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

Next Previous
X
Search
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

Price : $35 *
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

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 The previous primary end-points have been replaced by 36 new efficacy, safety and pharmacokinetic primary end-points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.

You need to be a logged in or subscribed to view this content Request demo

If your organization or you do not have a subscription, try one of the following:
  • Contacting your organization’s admin about adding this content to your AdisInsight subscription
  • Buying a PDF version of any individual profile
  • Request a free trial
If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top