UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006482
Receipt number R000007652
Scientific Title Analysis of sulpiride transition into the brain by using [C-11]sulpiride
Date of disclosure of the study information 2011/10/05
Last modified on 2011/10/05 16:18:16

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Analysis of sulpiride transition into the brain by using [C-11]sulpiride

Acronym

Sulpiride transition into the brain

Scientific Title

Analysis of sulpiride transition into the brain by using [C-11]sulpiride

Scientific Title:Acronym

Sulpiride transition into the brain

Region

Japan


Condition

Condition

Healthy male subjects

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Our aim is to study the transition of [C-11]sulpiride into the brain by using positron emission tomography (PET), and to determine whether oral administration of a therapeutic dose of sulpiride affects this transition.

Basic objectives2

PK,PD

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Transition of [C-11]sulpiride into the brain and changes in its transition after oral administration of a therapeutic dose of sulpiride.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Medicine

Interventions/Control_1

Intravenous injection of [C-11]sulpiride for brain PET imaging at baseline and after oral administration of a therapeutic dose of sulpiride.

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

40 years-old >

Gender

Male

Key inclusion criteria

Healthy volunteers who do not have any psychiatric disorders or serious medical illnesses and who are able to understand an explanatory document and give consent are included in this study

Key exclusion criteria

-Psychiatric disorders including drug dependence
-Serious medical illness

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroshi Ito

Organization

National Institute of Radiological Sciences

Division name

Molecular Imaging Center

Zip code


Address

4-9-1 Anagawa, Inage-ku, Chiba

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

National Institute of Radiological Sciences

Division name

A Planning Department study ethic management support unit

Zip code


Address


TEL


Homepage URL


Email

helsinki@nirs.go.jp


Sponsor or person

Institute

National Institute of Radiological Sciences

Institute

Department

Personal name



Funding Source

Organization

National Institute of Radiological Sciences

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2011 Year 10 Month 05 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Enrolling by invitation

Date of protocol fixation

2010 Year 10 Month 01 Day

Date of IRB


Anticipated trial start date

2011 Year 10 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 10 Month 05 Day

Last modified on

2011 Year 10 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007652


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name