NCT01613703

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 7, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Last Updated

June 3, 2013

Status Verified

May 1, 2013

Enrollment Period

7 months

First QC Date

June 5, 2012

Last Update Submit

May 31, 2013

Conditions

Healthy Adult Subjects

Keywords

ONO-2952Healthy adult subjectssingle doePET studySafetyTolerability

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

Study Arms (1)

Experimental

EXPERIMENTAL
Drug: ONO-2952

Interventions

ONO-2952DRUG

1 mg to 200 mg QD at a single descending dose

Experimental

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • History or presence of clinically significant disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pittsburgh Clinical Site

Pittsburgh, Pennsylvania, 15218, United States

Location

MeSH Terms

Interventions

ONO-2952

Study Officials

  • Ono Pharma USA, Inc.

    Ono Pharmaceutical Co. Ltd

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2012

First Posted

June 7, 2012

Study Start

August 1, 2012

Primary Completion

March 1, 2013

Last Updated

June 3, 2013

Record last verified: 2013-05

Locations

US(1)