Healthy condition
Conditions
Interventions
Single oral administration of 50 mL of [14C]KDT-3594 solution (equivalent to 0.4 mg as KDT-3594, approximately 0.75 MBq as administered radioactivity) under fasted conditions
Sponsors
Shimizu Yoshitaka
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Healthy Japanese male - Age: >18 to ==18.5 to =50 kg
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urinary and fecal radioactivity excretion and excretion rate, cumulative excretion and cumulative excretion rate, recovery and recovery rate, total recovery and total recovery rate | — |
Secondary
| Measure | Time frame |
|---|---|
| - Radioactivity concentration in whole blood and plasma - Concentration of unchanged drug and main metabolites in plasma - Metabolite profiling and structural estimation of metabolites in plasma, urine and feces - Incidence of adverse events and adverse drug reactions - Laboratory tests, vital signs, body weight, 12-lead ECG | — |
Contacts
Public ContactYoshitaka Shimizu
Kissei Pharmaceutical Co., Ltd.
Outcome results
None listed