ONO-1110-03 : A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ONO-1110 in Healthy Japanese Adult Male Subjects

JRCT ID: jRCT2071240014

Registered date:21/05/2024

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Healthy volunteers
• Date of first enrollment: 07/06/2024
• Target sample size: 6
• Study type: Interventional
• Intervention(s): Subjects receive a single oral dose of 180-mg ONO-1110.

Outcome(s)

• Primary Outcome: Plasma ONO-1110 concentrations and pharmacokinetic parameters
• 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

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) An individual who is receiving treatment for or has a history of a respiratory, cardiovascular, psychiatric, neurological, gastrointestinal, immunological, hepatic, renal, hematopoietic, endocrine, or other disease
2) Subjects with current or perious history of severe allergy to drugs or food
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: Namba Yoshinobu