NCT04874948

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

A Single-Center, Open Label Study to Investigate the Mass Balance, Excretion Pathways and Metabolites After a Single Oral Dose of 500 MG, 3.7 MBq, [14C]BTZ-043 in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Michael Hoelscher · Academic / Other
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Detailed description

A total of 4 evaluable subjects completing all procedures are required. Six (6) subjects will be enrolled in the cohort in order to have 4 evaluable subjects. The study will consist of a screening period (Day -21 to -2), a baseline period (Day -1), a single dose treatment on Day 1 with a minimum of 96 hours (=4 days) post dose in-house observation period (Days -1 up to afternoon Day 5), and a follow-up visit 30 days (±2 days) after the \[14C\]BTZ-043 dose. Subjects will be administered a single 500 mg \[14C\]BTZ-043 dose as drinking suspension. Subjects will be confined to the clinical site for at least 96 hours following drug administration (ie, afternoon of Day 5). During this time, blood, feces, and urine samples for measurement of \[14C\]BTZ-043 and metabolites will be collected. The subjects will be released from the clinic approximately 96 hours to 168 hours after dose administration and upon satisfactory recovery of radioactivity (at least 90%) approved by the Sponsor's scientific advisor after consulation of the Sponsor.

Conditions

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

Interventions

Type	Name	Description
DRUG	500mg BTZ-043 containing 3.7 MBq of [14C]BTZ-043	Single oral administration of 14C-labeled radioactive 500mg BTZ-043

Timeline

• Start date: 2021-10-08
• Primary completion: 2021-10-15
• Completion: 2021-11-09
• First posted: 2021-05-06
• Last updated: 2024-12-31
• Results posted: 2024-12-05

Locations

1 site across 1 country: Netherlands