Phase 1 Study of PBTZ169
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Open-label prospective non-comparative safety, tolerability and pharmacokinetics ascending
      dose randomized cohort study of PBTZ169 (capsules 40 mg) in fasted healthy volunteers after
      single and multiple oral administration
    

Detailed description: 
      Open-label prospective non-comparative safety, tolerability and pharmacokinetics ascending
      dose randomized cohort study of PBTZ169 (capsules 40 mg) in adult man healthy volunteers
      after single and multiple oral fasting administration. Study was conducted in one study
      center in Russian Federation. The study included two stages:

        -  Stage 1 - single oral fasting administration with dose escalation in 5 cohorts 6 healthy
           man volunteers each in main groups (plus 1 back-up volunteer in every group);

        -  Stage 2 - multiple oral fasting administration with dose escalation in 2 cohorts 6
           healthy man volunteers each in main groups (plus 1 back-up volunteer in every group).

      Screening procedures for each cohort performed within 7 days before the drug prescription and
      after the end of administration period in previous cohort. Screening in cohorts 2 and 6 was
      started only after safety tolerability and PK data analysis of previous cohorts.

      All volunteers met the study inclusion/exclusion criteria was included successively into the
      following cohorts on Stage 1 (actual data):

        -  Cohort 1 (C1) - 6 volunteers of the main group each of whom received once single dose of
           the drug - 1 capsule containing 40 mg of PBTZ169;

        -  Cohort 2 (C2) - 6 volunteers of the main group each of whom received once 80 mg of
           PBTZ169 (2 capsules 40 mg);

        -  Cohort 3 (C3) - 6 volunteers of the main group each of whom received once 160 mg of
           PBTZ169 (4 capsules 40 mg);

        -  Cohort 4 (C4) - 6 volunteers of the main group each of whom received once 320 mg of
           PBTZ169 (8 capsules 40 mg);

        -  Cohort 5 (C5) - 6 volunteers of the main group each of whom received once 640 mg of
           PBTZ169 (16 capsules 40 mg).

      On Stage 2 (actual data):

        -  Cohort 6 (C6) - 5 volunteers of the main group each of whom received 320 mg of PBTZ169
           (8 capsules 40 mg) once daily for 14 days;

        -  Cohort 7 (C7) - 5 volunteers of the main group each of whom received 640 mg of PBTZ169
           (16 capsules 40 mg) once daily for 14 days.

      Safety was assessed throughout the study. For every volunteer series of urine and venous
      blood samples was collected for the safety, tolerability and PK assessment of PBTZ169.
    

Intervention name(s): PBTZ169 - 40 mg; PBTZ169 - 80 mg; PBTZ169 - 160 mg; PBTZ169 - 320 mg; PBTZ169 - 640 mg; PBTZ169 - 320 mg (multiple administration); PBTZ169 - 640 mg (multiple administration)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 40 mg of PBTZ169 (1 capsule) orally once in fasting state; 80 mg of PBTZ169 (2 capsules 40 mg) orally once in fasting state; 160 mg of PBTZ169 (4 capsules 40 mg) orally once in fasting state; 320 mg of PBTZ169 (8 capsules 40 mg) orally once in fasting state; 640 mg of PBTZ169 (16 capsules 40 mg) orally once in fasting state; 320 mg of PBTZ169 (8 capsules 40 mg) orally once per day in fasting state for 14 days; 640 mg of PBTZ169 (16 capsules 40 mg) orally once per day in fasting state for 14 days
Other intervention name(s): PBTZ169; PBTZ169; PBTZ169; PBTZ169; PBTZ169; PBTZ169; PBTZ169
Intervention MeSH terms: Macozinone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Tuberculosis