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Absorption, Elimination and Safety of 14C-labeled Radioactive BTZ-043, a New Compound in TB Treatment

NCT04874948 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2024-12-31

Study results available
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Summary

This study is a Phase 1, single-center, open-label study to investigate the absorption, metabolism, and excretion of BTZ-043 after a single oral administration of 500 mg BTZ-043 containing 3.7 MBq of \[14C\]BTZ-043 in 4 healthy adult male subjects

Conditions

  • Tuberculosis
  • Tuberculosis, Pulmonary
  • Bacterial Infections Respiratory
  • Lung Diseases
  • Mycobacterium Infections

Interventions

DRUG

500mg BTZ-043 containing 3.7 MBq of [14C]BTZ-043

Single oral administration of 14C-labeled radioactive 500mg BTZ-043

Sponsors & Collaborators

  • Leibniz Institute for Natural Product Research and Infection Biology Hans Knöll Institute

    collaborator OTHER

  • Michael Hoelscher

    lead OTHER

Principal Investigators

  • Jan Jaap van Lier, MD · PRA Health Sciences (PRA) - Early Development Services (EDS)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2021-10-08
Primary Completion
2021-10-15
Completion
2021-11-09

Countries

  • Netherlands

Study Locations

More Related Trials

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 NCT04874948 on ClinicalTrials.gov