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

Sponsor

Ono Pharma USA Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT01613703

Collaborator

Ono Pharmaceutical Co. Ltd (Industry)

Enrollment

Location

Arm

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Adult Subjects	Drug: ONO-2952	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2012

Actual Primary Completion Date :

Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental	Drug: ONO-2952 1 mg to 200 mg QD at a single descending dose

Arm

Intervention/Treatment

Experimental: Experimental

Drug: ONO-2952

1 mg to 200 mg QD at a single descending dose

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts 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