ONO-1110-02:A PET Study to Evaluate Target Molecule Occupancy in the Brain of ONO-1110 in Healthy Japanese Adult Males
Phase 1
Recruiting
- Conditions
- Healthy volunteers(The planned indication has not been determined.)
- Registration Number
- JPRN-jRCT2071230063
- Lead Sponsor
- Osawa Masahiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
1) Japanese healthy adult male subjects
2) Age at the time of informed consent: 18 to 45
3) BMI (at screening): 18.5 kg/m2 to less than 30.0 kg/m2
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) Subjects with current or with a history of drug or alcohol abuse
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Target Molecule Occupancy in the Brain of ONO-1110 after single oral dose of ONO-1110 in Healthy Adult Males.
- Secondary Outcome Measures
Name Time Method 1)Safety, biodistribution and dosimetry of ONO-SE-853(18F) <br>2)Evaluation of Brain-targeting potential of ONO-SE-853(18F) <br>3)Evaluation of the relationship between plasma ONO-1110 concentration or ONO-1110 dose and target molecule occupancy of ONO-1110 in the brain<br>4)Safety of ONO-1110<br>5)Plasma ONO-1110 Concentrations