This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Phase 1 Study of PBTZ169

This study has been completed.
Sponsor:
Collaborator:
OCT LLC
Information provided by (Responsible Party):
Nearmedic Plus LLC
ClinicalTrials.gov Identifier:
NCT03036163
First received: September 14, 2016
Last updated: January 26, 2017
Last verified: January 2017
  Purpose
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

Condition Intervention Phase
Tuberculosis Drug: PBTZ169 - 40 mg Drug: PBTZ169 - 80 mg Drug: PBTZ169 - 160 mg Drug: PBTZ169 - 320 mg Drug: PBTZ169 - 640 mg Drug: PBTZ169 - 320 mg (multiple administration) Drug: PBTZ169 - 640 mg (multiple administration) Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Open-label Prospective Noncomparative Study of Safety, Tolerability and Pharmacokinetics of PBTZ169 After Single and Multiple Fasting Oral Administration in Increasing Doses in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Nearmedic Plus LLC:

Primary Outcome Measures:
  • Incidence of drug-related adverse events [Safety and tolerability] [ Time Frame: 14±1 days after the drug administration (up to last visit time point) ]

Secondary Outcome Measures:
  • Peak plasma concentration (Сmax) of PBTZ169 [ Time Frame: Up to 72 hours after the last drug administration ]
  • Time to reach maximum concentration (Tmax) of PBTZ169 [ Time Frame: Up to 72 hours after the last drug administration ]
  • Area under the plasma concentration versus time curve (AUC) of PBTZ169 [ Time Frame: Up to 72 hours after the last drug administration ]
    Areas under the curve AUC(0-t) and AUC(0-∞), ratio of AUC(0-t) to AUC(0-∞)

  • Plasma half-life time (T1/2) of PBTZ169 [ Time Frame: Up to 72 hours after the last drug administration ]
  • Mean plasma retention time (MRT) of PBTZ169 [ Time Frame: Up to 72 hours after the last drug administration ]
  • Total (plasma) clearance (Cl) of PBTZ169 [ Time Frame: Up to 72 hours after the last drug administration ]
  • Volume of distribution (Vd) of PBTZ169 [ Time Frame: Up to 72 hours after the last drug administration ]
  • Elimination constant (ke) of PBTZ169 [ Time Frame: Up to 72 hours after the last drug administration ]
  • renal clearance (Clren) of PBTZ169 [ Time Frame: Up to 72 hours after the last drug administration ]
  • Peak steady state plasma concentration (Cmax,ss) of PBTZ169 [ Time Frame: Up to 72 hours after the last drug administration ]
    For cohorts 6 and 7 (multiple administration) only

  • Time to reach maximum steady state concentration (Tmax,ss) of PBTZ169 [ Time Frame: Up to 72 hours after the last drug administration ]
    For cohorts 6 and 7 (multiple administration) only

  • Area under the plasma concentration versus time curve in steady state (AUCss) of PBTZ169 [ Time Frame: Up to 72 hours after the last drug administration ]
    For cohorts 6 and 7 (multiple administration) only

  • Volume of steady state distribution (Vd,ss) of PBTZ169 [ Time Frame: Up to 72 hours after the last drug administration ]
    For cohorts 6 and 7 (multiple administration) only


Enrollment: 35
Study Start Date: January 2016
Study Completion Date: November 2016
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
6 man healthy volunteers each of whom received once single oral dose of PBTZ169 - 40 mg (1 capsule)
Drug: PBTZ169 - 40 mg
40 mg of PBTZ169 (1 capsule) orally once in fasting state
Other Name: PBTZ169
Experimental: Cohort 2
6 man healthy volunteers each of whom received once single oral dose of PBTZ169 - 80 mg (2 capsules)
Drug: PBTZ169 - 80 mg
80 mg of PBTZ169 (2 capsules 40 mg) orally once in fasting state
Other Name: PBTZ169
Experimental: Cohort 3
6 man healthy volunteers each of whom received once single oral dose of PBTZ169 - 160 mg (4 capsules)
Drug: PBTZ169 - 160 mg
160 mg of PBTZ169 (4 capsules 40 mg) orally once in fasting state
Other Name: PBTZ169
Experimental: Cohort 4
6 man healthy volunteers each of whom received once single oral dose of PBTZ169 - 320 mg (8 capsules)
Drug: PBTZ169 - 320 mg
320 mg of PBTZ169 (8 capsules 40 mg) orally once in fasting state
Other Name: PBTZ169
Experimental: Cohort 5
6 man healthy volunteers each of whom received once single oral dose of PBTZ169 - 640 mg (16 capsules)
Drug: PBTZ169 - 640 mg
640 mg of PBTZ169 (16 capsules 40 mg) orally once in fasting state
Other Name: PBTZ169
Experimental: Cohort 6
6 man healthy volunteers each of whom received once daily for 14 days 320 mg of PBTZ169 (8 capsules 40 mg)
Drug: PBTZ169 - 320 mg (multiple administration)
320 mg of PBTZ169 (8 capsules 40 mg) orally once per day in fasting state for 14 days
Other Name: PBTZ169
Experimental: Cohort 7
6 man healthy volunteers each of whom received once daily for 14 days 640 mg of PBTZ169 (16 capsules 40 mg)
Drug: PBTZ169 - 640 mg (multiple administration)
640 mg of PBTZ169 (16 capsules 40 mg) orally once per day in fasting state for 14 days
Other Name: PBTZ169

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: Nearmedic Plus LLC
ClinicalTrials.gov Identifier: NCT03036163     History of Changes
Other Study ID Numbers: PBTZ169-Z00-C01-1
Study First Received: September 14, 2016
Last Updated: January 26, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Nearmedic Plus LLC:
Tuberculosis

Additional relevant MeSH terms:
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on September 21, 2017