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Phase 2a Study of PBTZ169

NCT03334734 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2020-03-09

Study results available
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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

Interventions

DRUG

PBTZ169

Once a day for 14 days

DRUG

Isoniazid

Once a day for 14 days

Sponsors & Collaborators

  • OCT LLC

    collaborator INDUSTRY

  • Nearmedic Plus LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-16
Primary Completion
2017-09-10
Completion
2018-02-22

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03334734 on ClinicalTrials.gov