Healthy Adult Subjects
Conditions
Keywords
ONO-2952, Healthy adult subjects, single doe, PET study, Safety, Tolerability
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.
Interventions
DRUGONO-2952
1 mg to 200 mg QD at a single descending dose
Sponsors
Ono Pharmaceutical Co. Ltd
Ono Pharma USA Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| To evaluate the relationship between TSPO occupancy and the plasma concentration of ONO-2952 | 2 days |
| To investigate the safety and tolerability of ONO-2952 in healthy adult subjects | 14 days |
Countries
United States
Outcome results
None listed