A mass-balance study of [14C]KDT-3594 in healthy adult male

JRCT ID: jRCT2071220057

Registered date:16/10/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Healthy condition
• Date of first enrollment: 08/11/2022
• Target sample size: 8
• Study type: Interventional
• Intervention(s): 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

Outcome(s)

• Primary Outcome: 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 Outcome

- 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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 45age old
• Gender: Male

Include criteria

- Healthy Japanese male
- Age: >18 to =<45 years old
- BMI: >=18.5 to <25.0 kg/m2
- Body weight: >=50 kg

• Exclude 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)

Related Information

• Primary Sponsor: Shimizu Yoshitaka