臨床研究等提出・公開システム

ONO-2020-04: An Open-label, Phase I, Single-dose Study to Investigate the Mass Balance of ONO-2020 after Oral Administration of 14C-ONO-2020 in Japanese Healthy Adult Male Subjects

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

Hirashima Yoshinori

Ono Pharmaceutical Co.,LTD.

1-8-2 Kyutaromachi, Chuo-ku Osaka-shi, Osaka-fu Japan

clinical_trial@ono-pharma.com

JP Clinical Trial Support Desk

Ono Pharmaceutical Co.,LTD.

1-8-2 Kyutaromachi, Chuo-ku Osaka-shi, Osaka-fu Japan

+81-120-278-120

clinical_trial@ono-pharma.com

Complete

Feb. 27, 2026

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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

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

Male

Healthy Volunteers

Urinary and fecal excretion rates of radioactivity and cumulative excretion rates of radioactivity

Urinary and fecal excretion rates of radioactivity and cumulative excretion rates of radioactivity

Adverse events that occurred after administration of investigational product until the end of final examination

+81-92-283-7701

Feb. 26, 2026

No

none