Skip to content

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

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

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2071250125
Enrollment
6
Registered
2026-01-23
Start date
2026-02-27
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Interventions

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

Sponsors

Hirashima Yoshinori
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

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

Secondary

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

Contacts

Public ContactSupport Desk JP

Ono Pharmaceutical Co.,LTD.

clinical_trial@ono-pharma.com+81-120-278-120

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026