ONO-2952 Single-dose PET Study in Healthy Adult Subjects
- Registration Number
- NCT01613703
- Lead Sponsor
- Ono Pharma USA Inc
- Brief Summary
The primary objective of this study is to evaluate the brain TSPO occupancy of ONO-2952 in healthy adult subjects after a single dose using \[11C\]PBR28 as a specific PET ligand for TSPO. The secondary objective is to evaluate the relationship between TSPO occupancy and the plasma concentration of ONO-2952 and to investigate the safety and tolerability of ONO-2952 in healthy subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
Inclusion Criteria
- Healthy non-smoking male or female subjects (18-55 inclusive)
- Body mass index (BMI) of 19-35 kg/m2 (inclusive)
- For females, surgically sterilized, postmenopausal, or who are non- lactating and agree to use a double barrier method of contraception
Exclusion Criteria
- History or presence of clinically significant disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Experimental ONO-2952 -
- Primary Outcome Measures
Name Time Method To evaluate the brain TSPO occupancy of ONO-2952 in healthy adult subjects after a single dose using [11C]PBR28 as a specific PET ligand for TSPO 2 days
- Secondary Outcome Measures
Name Time Method To investigate the safety and tolerability of ONO-2952 in healthy adult subjects 14 days To evaluate the relationship between TSPO occupancy and the plasma concentration of ONO-2952 2 days
Trial Locations
- Locations (1)
Pittsburgh Clinical Site
🇺🇸Pittsburgh, Pennsylvania, United States