Phase 1 Study of PBTZ169

NCT03036163 | Completed Phase 1 Results DMC

• 1 other identifier: PBTZ169-Z00-C01-1
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Tuberculosis

Keywords

Tuberculosis

Outcome Measures

Primary Outcomes (1)

• Incidence of Drug-related Adverse Events [Safety and Tolerability]

  The frequency of adverse events for which a relationship to the test drug PBTZ169 was noted

  14±1 days after the drug administration (up to last visit time point)

Secondary Outcomes (15)

• Peak Plasma Concentration (Сmax) of PBTZ169

  Up to 72 hours after the last drug administration

• Time to Reach Maximum Concentration (Tmax) of PBTZ169

  Up to 72 hours after the last drug administration

• Area Under the Concentration-time Curve (AUC0-∞)

  Up to 72 hours after the last drug administration

• Plasma Half-life Time (T1/2) of PBTZ169

  Up to 72 hours after the last drug administration

• Mean Plasma Retention Time (MRT) of PBTZ169

  Up to 72 hours after the last drug administration

Study Arms (7)

Cohort 1

EXPERIMENTAL

6 male healthy volunteers each of whom received once single oral dose of PBTZ169 - 40 mg (1 capsule)

Drug: PBTZ169 - 40 mg

Cohort 2

EXPERIMENTAL

6 male healthy volunteers each of whom received once single oral dose of PBTZ169 - 80 mg (2 capsules)

Drug: PBTZ169 - 80 mg

Cohort 3

EXPERIMENTAL

6 male healthy volunteers each of whom received once single oral dose of PBTZ169 - 160 mg (4 capsules)

Drug: PBTZ169 - 160 mg

Cohort 4

EXPERIMENTAL

6 male healthy volunteers each of whom received once single oral dose of PBTZ169 - 320 mg (8 capsules)

Drug: PBTZ169 - 320 mg

Cohort 5

EXPERIMENTAL

6 male healthy volunteers each of whom received once single oral dose of PBTZ169 - 640 mg (16 capsules)

Drug: PBTZ169 - 640 mg

Cohort 6

EXPERIMENTAL

5 male 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)

Cohort 7

EXPERIMENTAL

5 male 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)

Interventions

PBTZ169 - 40 mg DRUG

40 mg of PBTZ169 (1 capsule) orally once in fasting state

Also known as: PBTZ169

Cohort 1

PBTZ169 - 80 mg DRUG

80 mg of PBTZ169 (2 capsules 40 mg) orally once in fasting state

Also known as: PBTZ169

Cohort 2

PBTZ169 - 160 mg DRUG

160 mg of PBTZ169 (4 capsules 40 mg) orally once in fasting state

Also known as: PBTZ169

Cohort 3

PBTZ169 - 320 mg DRUG

320 mg of PBTZ169 (8 capsules 40 mg) orally once in fasting state

Also known as: PBTZ169

Cohort 4

PBTZ169 - 640 mg DRUG

640 mg of PBTZ169 (16 capsules 40 mg) orally once in fasting state

Also known as: PBTZ169

Cohort 5

PBTZ169 - 320 mg (multiple administration) DRUG

320 mg of PBTZ169 (8 capsules 40 mg) orally once per day in fasting state for 14 days

Also known as: PBTZ169

Cohort 6

PBTZ169 - 640 mg (multiple administration) DRUG

640 mg of PBTZ169 (16 capsules 40 mg) orally once per day in fasting state for 14 days

Also known as: PBTZ169

Cohort 7

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Written informed consent received from a volunteer.
• Man aged 18 to 45 years old, inclusive.
• Body mass index of 18.5-25 kg/m2.
• 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).
• Ability, according to investigators opinion, to comply with all requirements of the protocol.
• 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

You may not qualify if:

• Aggravated allergic history, including presence of at least one episode of drug allergy.
• Chronic diseases of cardiovascular, bronchopulmonary, neuroendocrine systems, ENT and gastrointestinal, hepatic, renal, blood and cutaneous diseases.
• Chronic diseases of eyes except for mild to moderate myopia, hypermetropia and astigmatism.
• Gastrointestinal surgeries (except for appendectomy performed not less than 1 year before screening).
• Acute infections within less than 4 weeks before screening.
• Regular drug administration within less than 4 weeks before screening.
• Regular administration or application (including topical) of hormonal drugs for more than 1 week within less than 45 days before the screening.
• Administration of drugs exerting evident effects on hemodynamics, hepatic function, etc. (barbiturates, omeprazole, cimetidine, etc.) within less than 45 days before the screening.
• Positive tests for narcotic and psychotropic agents.
• Donation (450 mL of blood or plasma) within less than 3 months before the screening.
• 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.
• Mental illnesses.
• Smoking within half a year before the screening.
• Previous participation in this clinical study and withdrawal from it due to any reason.
• Participation in other clinical studies of drugs within less than 6 months before the screening.

Sponsors & Collaborators

• Nearmedic Plus LLC: lead
• OCT LLC: collaborator

MeSH Terms

Conditions

Tuberculosis

Interventions

macozinone

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Viсtoria Shcherbakova
• Organization: Nearmedic Plus

Viktoriya.Shcherbakova@nearmedic.ru

+7 (495) 741 49 89

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2016
• First Posted: January 30, 2017
• Study Start: January 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: November 1, 2016
• Last Updated: April 13, 2020
• Results First Posted: April 13, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share