NIPH Clinical Trials Search

ONO-2020-04: A Study to Investigate the Mass Balance of ONO-2020 in Japanese Healthy Adult Male Subjects

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Healthy Volunteers
Date of first enrollment	27/02/2026
Target sample size	6
Countries of recruitment
Study type	Interventional
Intervention(s)	Urinary and fecal excretion rates of radioactivity and cumulative excretion rates of radioactivity

Outcome(s)

Primary Outcome	Urinary and fecal excretion rates of radioactivity and cumulative excretion rates of radioactivity
Secondary Outcome	Adverse events that occurred after administration of investigational product until the end of final examination

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	<= 45age old
Gender	Male
Include criteria	1) Healthy Japanese adult males 2) The subject is aged 18 to 45 years, inclusive, at the time of signing the informed consent form 3) The subject has a BMI of 18.5 kg/m2 or more and less than 25.0 kg/m2 (rounded down to 2 decimal places) at screening 4) The subject whose body weight at screening is at least 50 kg and no more than 100 kg
Exclude criteria	1) Subjects who are on a treatment for or with a history of respiratory, cardiovascular, psychiatric, neurologic, gastrointestinal, immunologic, hepatic, renal, hematopoietic or endocrine and/or other disease 2) Subjects with current or with a history of severe allergy to drugs or foods 3) The subject who is judged by the investigator or subinvestigator to be inappropriate as a subject of this study based on the results of screening tests