At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 4 enrolled
Drug / intervention
500mg BTZ-043 containing 3.7 MBq of [14C]BTZ-043drug
Likely dose
500mg BTZ-043 containing 3.7 MBq of [14C]BTZ-043from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating 500mg BTZ-043 containing 3.7 MBq of [14C]BTZ-043 for Tuberculosis and 4 related conditions. Completed, enrolled 4 participants across 1 site.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTuberculosis, Tuberculosis, Pulmonary, Bacterial Infections Respiratory, Lung Diseases, Mycobacterium Infections
CountriesNetherlands
Timeline
Phase 1CompletedFinished
20222023202420252026
First PostedMay 2021
Enrollment StartOct 2021
Primary CompletionOct 2021
Study CompletionNov 2021
TodayJul 2026
First PostedMay 6, 2021
Enrollment StartOct 8, 2021
Primary CompletionOct 15, 2021
Study CompletionNov 9, 2021
TodayJul 2, 2026
Enrollment to primary: 7 daysPosted 5.2 years ago
Interventions
500mg BTZ-043 containing 3.7 MBq of [14C]BTZ-043drug
Single oral administration of 14C-labeled radioactive 500mg BTZ-043