UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004786
Receipt number R000005697
Scientific Title PET microdose study of donepezi in humans
Date of disclosure of the study information 2010/12/24
Last modified on 2010/12/24 14:14:45

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Basic information

Public title

PET microdose study of donepezi in humans

Acronym

Donepezil PET

Scientific Title

PET microdose study of donepezi in humans

Scientific Title:Acronym

Donepezil PET

Region

Japan


Condition

Condition

normal volunteer

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

to elucidate pharmacokinetics of donepezil in normal volunteers

Basic objectives2

Pharmacokinetics

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

radioactivity of donpezil in the brain

Key secondary outcomes

sequential changes in donepezil radioactivity in the brain by 60minafter administration


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Dose comparison

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

To analyze pharmacokinetics of C-11 donepezil after 1mg (n=6) oral administration. The study period is from January to March 2022.

Interventions/Control_2

To analyze pharmacokinetics of C-11 donepezil after 3mg (n=6) oral administration. The study period is from January to March 2022.

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

40 years-old <=

Age-upper limit

65 years-old >=

Gender

Male and Female

Key inclusion criteria

normal volunteer

Key exclusion criteria

liver dysfunction, ECG abnormality, past history of gastric ulcer, symptoms of extrapyramidal systems, intake of other drugs, pregnant,

Target sample size

12


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Jun Hatazawa

Organization

Osaka University Hospital

Division name

Nuclear Medicine

Zip code


Address

2-2 Yamadaoka Suita, Osaka

TEL

81-6-6879-3461

Email



Public contact

Name of contact person

1st name
Middle name
Last name Jun Hatazawa

Organization

Osaka University Hospital

Division name

Nuclear Medicine

Zip code


Address

2-2 Yamadaoka Suita, Osaka

TEL

81-6-6879-3461

Homepage URL

http://www.tracer.med.osaka-u.ac.jp/index-jp.htm

Email

hatazawa@tracer.med.osaka-u.ac.jp


Sponsor or person

Institute

Department of Nuclear Medicine, Osaka University Hospital

Institute

Department

Personal name



Funding Source

Organization

New Energy and Industrial Technology Development Organization Japan

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


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

大阪大学医学部附属病院(大阪府)


Other administrative information

Date of disclosure of the study information

2010 Year 12 Month 24 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

Open public recruiting

Date of protocol fixation

2010 Year 12 Month 24 Day

Date of IRB


Anticipated trial start date

2010 Year 12 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

2010 Year 12 Month 24 Day

Last modified on

2010 Year 12 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005697


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name