Phase 1 Study of PBTZ169
Condition: Tuberculosis
MeSH terms: Tuberculosis
Intervention: 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 description: 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
Intervention MeSH terms: Macozinone
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Tuberculosis

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
    

Eligibility criteria:

        Inclusion Criteria:

          1. Written informed consent received from a volunteer.

          2. Man aged 18 to 45 years old, inclusive.

          3. Body mass index of 18.5-25 kg/m2.

          4. Verified diagnosis: "healthy" according to data of standard clinical, laboratory and
             instrumental examination methods performed at screening:

               -  Absence of deviations of physical examination parameters and vital signs
                  (systolic blood pressure - 100-129 mm Hg, inclusive; diastolic blood pressure -
                  70-89 mm Hg, inclusive; heart rate - 60-80 bpm, inclusive);

               -  Absence of deviations of laboratory parameters (complete blood count, blood
                  biochemistry, urinalysis and tests for HIV, HBV, HCV, syphilis);

               -  Normal parameters of 12-lead ECG;

               -  Normal results of photofluorographic or X-ray examination (the results received
                  maximum 6 months before screening can be used).

          5. Ability, according to investigators opinion, to comply with all requirements of the
             protocol.

          6. Agreement to use double contraception method during the study participation and for 3
             months after the test drug administration - combination of male condom with not less
             than one of the following methods:

               -  female partner using hormonal contraception;

               -  using aerosols, creams, suppositories and other agents containing spermicides;

               -  female partner using intrauterine device

        Exclusion Criteria:

          1. Aggravated allergic history, including presence of at least one episode of drug
             allergy.

          2. Chronic diseases of cardiovascular, bronchopulmonary, neuroendocrine systems, ENT and
             gastrointestinal, hepatic, renal, blood and cutaneous diseases.

          3. Chronic diseases of eyes except for mild to moderate myopia, hypermetropia and
             astigmatism.

          4. Gastrointestinal surgeries (except for appendectomy performed not less than 1 year
             before screening).

          5. Acute infections within less than 4 weeks before screening.

          6. Regular drug administration within less than 4 weeks before screening.

          7. Regular administration or application (including topical) of hormonal drugs for more
             than 1 week within less than 45 days before the screening.

          8. Administration of drugs exerting evident effects on hemodynamics, hepatic function,
             etc. (barbiturates, omeprazole, cimetidine, etc.) within less than 45 days before the
             screening.

          9. Positive tests for narcotic and psychotropic agents.

         10. Donation (450 mL of blood or plasma) within less than 3 months before the screening.

         11. Intake of more than 10 U of alcohol per week (1 unit of alcohol is equivalent to 500
             mL of beer, 200 mL of vine or 50 mL of strong alcoholic drink) or historical data on
             alcoholism, narcomania, drug abuse.

         12. Mental illnesses.

         13. Smoking within half a year before the screening.

         14. Previous participation in this clinical study and withdrawal from it due to any
             reason.

         15. Participation in other clinical studies of drugs within less than 6 months before the
             screening.

         16. Planned conception or sperm donation during the study after the test drug
             administration or during 3 months after the date of drug administration.