A mass-balance study of [14C]KDT-3594 in healthy adult male
Phase 1
- Conditions
- Healthy condition
- Registration Number
- JPRN-jRCT2071220057
- Lead Sponsor
- Shimizu Yoshitaka
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 8
Inclusion Criteria
Healthy Japanese male
- Age: >18 to =<45 years old
- BMI: >=18.5 to <25.0 kg/m2
- Body weight: >=50 kg
Exclusion Criteria
Subjects with complication or history of clinically significant hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, (including alcoholic liver disease, non-alcoholic steatohepatitis (NASH), autoimmune hepatitis, and hereditary liver disease), psychiatric, neurological, or allergic disease (including drug allergy, but excluding untreated, asymptomatic or seasonal allergy at the time of administration)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method rinary and fecal radioactivity excretion and excretion rate, cumulative excretion and cumulative excretion rate, recovery and recovery rate, total recovery and total recovery rate
- Secondary Outcome Measures
Name Time Method - Radioactivity concentration in whole blood and plasma<br>- Concentration of unchanged drug and main metabolites in plasma<br>- Metabolite profiling and structural estimation of metabolites in plasma, urine and feces<br>- Incidence of adverse events and adverse drug reactions<br>- Laboratory tests, vital signs, body weight, 12-lead ECG