A mass-balance study of [14C]KDT-3594 in healthy adult male
- Conditions
- Healthy condition
- Registration Number
- jRCT2071220057
- Lead Sponsor
- Kissei Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 8
- Healthy Japanese male
- Age: >18 to =<45 years old
- BMI: >=18.5 to <25.0 kg/m2
- Body weight: >=50 kg
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
- single assignment
- Primary Outcome Measures
Name Time Method Urinary radioactivity excretion 放射性物质在尿液中的排泄量
Urinary radioactivity excretion rate 放射性物质在尿液中的排泄速率
Fecal radioactivity excretion 放射性物质在粪便中的排泄量
Fecal radioactivity excretion rate 放射性物质在粪便中的排泄速率
Cumulative excretion 放射性物质的累积排泄量
Recovery 放射性物质的回收量
Total recovery rate 放射性物质的总回收速率
Cumulative excretion rate 放射性物质的累积排泄速率
Recovery rate 放射性物质的回收速率
Total recovery 放射性物质的总回收量
- Secondary Outcome Measures
Name Time Method Concentration of unchanged drug and main metabolites in plasma Concentration of unchanged drug and main metabolites in plasma
Metabolite profiling and structural estimation of metabolites in plasma, urine and feces Metabolite profiling and structural estimation of metabolites in plasma, urine and feces
Incidence of adverse events and adverse drug reactions Incidence of adverse events and adverse drug reactions
Laboratory tests, vital signs, body weight, 12-lead ECG Laboratory tests, vital signs, body weight, 12-lead ECG
Radioactivity concentration in whole blood and plasma Radioactivity concentration in whole blood and plasma