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

Exclusion criteria

• . Participation in another study with a radiation burden of \>0.1 mSv and ≤1 mSv in the period of 1 year prior to screening; a radiation burden of \>1.1 mSv and ≤2 mSv in the period of 2 years prior to screening; a radiation burden of \>2.1 mSv and ≤3 mSv in the period of 3 years prior to screening, etc.
• . Exposure to radiation for diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton \[excluding spinal column\]), or during work within 1 year prior to drug administration.
• . Irregular defecation pattern (less than once per day on average).
• . Employee of PRA, Nuvisan, or the Sponsor.
• . History of relevant drug and/or food allergies.
• . Using tobacco products within 60 days prior to drug administration.
• . History of alcohol abuse or drug addiction (including soft drugs like cannabis products).
• . Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines \[including ecstasy\], cannabinoids, barbiturates, benzodiazepines, gamma-hydroxybutyric acid, tricyclic antidepressants, and alcohol) at screening or admission to the clinical research center.

Plasma PK of BTZ-043 and Main Metabolites (AUC-last)

Timeframe: Day 1 to Day 3