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An open-label study to evaluate the extended early bactericidal activity, safety, tolerability and pharmacokinetics of multiple doses (m.d.) of TMC207 oral solution (os) and isoniazid (JH), m.d. of TMC207 os and pyrazinamide (JZ), m.d. of TMC207 os and rifampin (JR) or m. oral d. of TMC207 os and isoniazid and pyrazinamide (JHZ), compared to the 3 principle drugs of standard anti-tuberculosis treatment (HRZ) in treatment-naïve subjects with sputum-smear positive pulmonary tuberculosis.

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Trial Profile

An open-label study to evaluate the extended early bactericidal activity, safety, tolerability and pharmacokinetics of multiple doses (m.d.) of TMC207 oral solution (os) and isoniazid (JH), m.d. of TMC207 os and pyrazinamide (JZ), m.d. of TMC207 os and rifampin (JR) or m. oral d. of TMC207 os and isoniazid and pyrazinamide (JHZ), compared to the 3 principle drugs of standard anti-tuberculosis treatment (HRZ) in treatment-naïve subjects with sputum-smear positive pulmonary tuberculosis.

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 30 Jul 2020

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At a glance

  • Drugs Bedaquiline (Primary) ; Isoniazid; Pyrazinamide; Rifampicin
  • Indications Pulmonary tuberculosis
  • Focus Therapeutic Use
  • Sponsors Janssen R&D Ireland

    • Most Recent Events

    • 30 Jul 2020 New trial record

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