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Study to Evaluate the Safety, Tolerability and Pharmacokinetics of PBTZ169 in Multiple Dosing

NCT03776500 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2020-10-22

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-controlled, multiple ascending dose study conducted at one study center in Switzerland.

Four (4) panels (A, B, C and D) of 8 male subjects (6 active and 2 placebo) each receiving multiple doses of PBTZ169 or a matching placebo, at increasing dose levels, once or twice daily.

Subjects will participate in only one panel. Blocks of 4 subjects (3 under active treatment, 1 under placebo) will be investigated in parallel. Panels will start sequentially.

Safety will be assessed throughout the study; serial ECGs and serial blood samples will be collected for the safety and PK assessment of PBTZ169.

Dose escalation will be allowed once the Trial Safety Board has determined that adequate safety and tolerability after each panel completion has been demonstrated to permit proceeding to the next panel.

In addition, a preliminary assessment of the drug interaction potential of PBTZ169 will be done by the measurement of inhibition or induction of human cytochromes through the metabolism of microdoses of standard probe substrates

Conditions

  • Tuberculosis, Pulmonary

Interventions

DRUG

PBTZ169

PBTZ169 crystalline supplied as powder for oral solution

DRUG

Placebo

matching placebo supplied as powder for oral solution

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Innovative Medicines for Tuberculosis

    lead OTHER

Principal Investigators

  • Stewart T Cole, Prof · innovative Medicines for Tuberculosis (iM4TB)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
48 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-21
Primary Completion
2020-03-20
Completion
2020-03-20

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Drugs

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 NCT03776500 on ClinicalTrials.gov