Phase 2a Study of PBTZ169

NCT03334734 | Terminated Phase 2 Results DMC

• 1 other identifier: PBTZ169-A15-C2A-1
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

Multicenter, open, randomized study with active control (isoniazid) to evaluate the early antibacterial activity, safety and pharmacokinetics of the drug PBTZ169 (capsules 80 mg) when used in patients with first-diagnosed tuberculosis of the respiratory system with bacterial excretion and saved bacterial susceptibility to isoniazid and rifampicin

Conditions

Tuberculosis

Keywords

Tuberculosis; PBTZ169; antimycobacterial

Outcome Measures

Primary Outcomes (2)

• Early Bactericidal Activity (0-14)

  Early bactericidal activity 14 days from the monotherapy start date (EBA 0-14): agar inoculation, the mean of two measurements at the Visit

  14 days after the onset of monotherapy

• Early Bactericidal Activity (0-14)

  Early bactericidal activity 14 days from the monotherapy start date (EBA 0-14): PCR, the mean of two measurements at the Visit

  14 days after the onset of monotherapy

Secondary Outcomes (25)

• Early Bactericidal Activity (0-2)

  2 days after the onset of monotherapy

• Early Bactericidal Activity (0-7)

  7 days after the onset of monotherapy

• Early Bactericidal Activity (0-2)

  2 days after the onset of monotherapy

• Early Bactericidal Activity (0-7)

  7 days after the onset of monotherapy

• Peak Plasma Concentration (Сmax) of PBTZ169

  Up to 72 hours after the last drug administration

Study Arms (4)

PBTZ169, 160 mg

EXPERIMENTAL

2 capsules 80 mg of PBTZ169 once a day for 14 days

Drug: PBTZ169

PBTZ169, 320 mg

EXPERIMENTAL

4 capsules 80 mg of PBTZ169 once a day for 14 days

Drug: PBTZ169

PBTZ169, 640 mg

EXPERIMENTAL

8 capsules 80 mg of PBTZ169 once a day for 14 days

Drug: PBTZ169

Isoniazid, 600 mg

ACTIVE COMPARATOR

2 tablets 300 mg of Isoniazid once a day for 14 days

Drug: Isoniazid

Interventions

PBTZ169 DRUG

Once a day for 14 days

PBTZ169, 160 mg; PBTZ169, 320 mg; PBTZ169, 640 mg

Isoniazid DRUG

Once a day for 14 days

Isoniazid, 600 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent received from a volunteer
• Men and women aged 18 to 65 years, inclusive
• The first-diagnosed active pulmonary tuberculosis, confirmed by characteristic radiographic changes (infiltration, dissemination, destruction) during radiography or computed tomography of chest organs, without damage to other organs or with the defeat of one or more of the following organs: larynx, trachea, bronchi, lymph nodes
• The amount of sputum given by the patient is sufficient for carrying out the analyzes provided for by the protocol, but not less than 4-5 ml at the screening
• The presence of acid-fast mycobacteria in the sputum according to the results of microscopy of smears (1+ and more using the method of microscopy with luminescent dye staining according to the Order of the Ministry of Health of the Russian Federation of March 21, 2003 No. 109, the last edition) and the detection of the DNA of mycobacteria of tuberculosis by the results of molecular genetic methods of diagnosis
• Body weight not less than 51 kg
• Body mass index of 18.5-25 kg/m2
• 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:

• Extrapulmonary localization of tuberculosis
• Presence of resistance to rifampicin and / or isoniazid in the study of sputum samples using molecular genetic methods
• The presence of absolute indications for surgical treatment of tuberculosis at the time of screening
• Positive tests for serological markers of syphilis or HIV infection during screening; active hepatitis or decompensated hepatic cirrhosis
• Aggravated allergic history, including presence of at least one episode of drug allergy
• The values of renal and / or hepatic parameters according to laboratory analyzes (taking into account the range of normal laboratory values):
• Aspartate aminotransferase (AST) level \> 2.0 x upper limit of the norm
• Alanine aminotransferase (ALT) level \> 2.0 x upper limit of norm
• General bilirubin level \> 1.5 x upper limit of norm
• Creatinine level \> 1.5 x upper limit of norm
• Individual drug components intolerance
• Presence in the anamnesis of malignant neoplasms, except for basal cell skin cancer
• The presence of severe chronic somatic diseases in the stage of decompensation, including diseases of the cardiovascular, bronchopulmonary, neuroendocrine system, ear, nose and throat (ENT) organs, the gastrointestinal tract, liver, kidneys, blood, skin, or any other somatic or mental diseases that, according to the researcher, prevent the patient from entering the study
• Gastrointestinal surgeries (except for appendectomy performed not less than 1 year before screening)
• Mental illness that may interfere with the patient's compliance with the protocol

Sponsors & Collaborators

• Nearmedic Plus LLC: lead
• OCT LLC: collaborator

MeSH Terms

Conditions

Tuberculosis

Interventions

macozinone; Isoniazid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Hydrazines; Organic Chemicals; Isonicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

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 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2017
• First Posted: November 7, 2017
• Study Start: December 16, 2016
• Primary Completion: September 10, 2017
• Study Completion: February 22, 2018
• Last Updated: March 9, 2020
• Results First Posted: March 9, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share