NIPH Clinical Trials Search

ONO-1110-02:A PET Study to Evaluate Target Molecule Occupancy in the Brain of ONO-1110 in Healthy Japanese Adult Males

Basic Information

Recruitment status	Complete
Health condition(s) or Problem(s) studied	Healthy volunteers(The planned indication has not been determined.)
Date of first enrollment	14/09/2023
Target sample size	40
Countries of recruitment
Study type	Interventional
Intervention(s)	1) Part A:Subjects receive single intravenous administration of ONO-SE-853(18F). 2) Part B:In the period1, subjects receive single intravenous administration of ONO-SE-853(18F). In the period2, subjects receive single oral dose of ONO-1110 and single intravenous administration of ONO-SE-853(18F).

Outcome(s)

Primary Outcome	Target Molecule Occupancy in the Brain of ONO-1110 after single oral dose of ONO-1110 in Healthy Adult Males.
Secondary Outcome	1)Safety, biodistribution and dosimetry of ONO-SE-853(18F) 2)Evaluation of Brain-targeting potential of ONO-SE-853(18F) 3)Evaluation of the relationship between plasma ONO-1110 concentration or ONO-1110 dose and target molecule occupancy of ONO-1110 in the brain 4)Safety of ONO-1110 5)Plasma ONO-1110 Concentrations

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	<= 45age old
Gender
Include 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
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) Subjects with current or with a history of drug or alcohol abuse