ONO-2808-05:A Study to Investigate the Mass Balance of ONO-2808 in Japanese Healthy Adult Male Subjects

JRCT ID: jRCT2071240057

Registered date:11/09/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healthy Volunteers
• Date of first enrollment: 11/10/2024
• Target sample size: 6
• Study type: Interventional
• Intervention(s): Subjects receive a single oral dose of 20 mg(1 MBq) 14C-ONO-2808

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

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

Related Information

• Primary Sponsor: Hirashima Yoshinori