ONO-2952 Single-dose PET Study in Healthy Adult Subjects
| Status: | Recruiting |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 5/27/2013 |
| Start Date: | August 2012 |
| Contact: | Brenda Souza |
| Phone: | 1-609-512-4129 |
Open-Label, Single-Center, Single Dose Positron Emission Topography (PET) Using [11C]PBR28 to Evaluate Brain Translocator Protein 18KDa (TSPO) Occupancy of ONO-2952 in Healthy Adult Subjects
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.
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
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