ONO-2952 Single-dose PET Study in Healthy Adult Subjects

Ono Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Adult Subjects

Treatments: Drug: ONO-2952

Study type: Interventional

Funder types: Industry

Identifiers

NCT01613703

ONO-2952POU003

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Experimental

Experimental group

Treatment:

Drug: ONO-2952