ONO-2952 Single-dose PET Study in Healthy Adult Subjects | NCT01613703

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

NCT01613703

Sponsor

Ono Pharma USA Inc

Status

Completed

Last Update Posted

Jun 3, 2013Estimated

Enrollment

16Actual

Phase

Phase 1

Conditions

Healthy Adult Subjects

Interventions

ONO-2952

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2012

Primary Completion Date

Mar 2013Actual

Completion Date

Not provided

First Submitted Date

Jun 5, 2012

First Submission Date that Met QC Criteria

Jun 6, 2012

First Posted Date

Jun 7, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 31, 2013

Last Update Posted Date

Jun 3, 2013Estimated

Name	Class
Ono Pharmaceutical Co., Ltd.	INDUSTRY

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental	Experimental		Drug: ONO-2952

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ONO-2952	Drug	1 mg to 200 mg QD at a single descending dose	Experimental

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ono Pharma USA, Inc.	Ono Pharmaceutical Co., Ltd.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pittsburgh Clinical Site		Pittsburgh	Pennsylvania	15218	United States

Intervention Browse Module

MeSH Terms

ID	Term
C000607300	ONO-2952

Ancestor Terms

Not provided

Browse Leaves

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Browse Branches

Not provided