UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026357
Receipt number R000030285
Scientific Title Clinical trial to examine the effective dose and the safety of [11C]K-2 synthesized by dedicated machine in healthy male volunteers
Date of disclosure of the study information 2017/03/06
Last modified on 2018/08/29 17:15:05

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Basic information

Public title

Clinical trial to examine the effective dose and the safety of [11C]K-2 synthesized by dedicated machine in healthy male volunteers

Acronym

Clinical trial to examine the effective dose and the safety of [11C]K-2 synthesized by dedicated machine in healthy male volunteers

Scientific Title

Clinical trial to examine the effective dose and the safety of [11C]K-2 synthesized by dedicated machine in healthy male volunteers

Scientific Title:Acronym

Clinical trial to examine the effective dose and the safety of [11C]K-2 synthesized by dedicated machine in healthy male volunteers

Region

Japan


Condition

Condition

Healthy volunteers

Classification by specialty

Neurology Neurosurgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this trial is to examine the effective dose and the safety of [11C]K-2 synthesized by dedicated machine in healthy male volunteers

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase I


Assessment

Primary outcomes

Effective dose of [11C]K-2 in human

Key secondary outcomes

The safety of [11C]K-2
The time-elapsed change of serum and urine radio activity
The time-elapsed change of unaltered compound and metabolites


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Dose comparison

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking


Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

[11C]K-2 370MBq

Interventions/Control_2

[11C]K-2 555MBq

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

1. Japanese healthy male volunteer
2. Age is between 20-40
3. BMI is between 18.5-25.0

Key exclusion criteria

(Exclusion criteria at the stage of screening)
1. The man who has past or current history of psychiatric disorder and another severe illness
2. Current smoker or past smoker who quit smoking within 6 months
3. The man who is disclosed brain disease by MRI study
4. The man who shows deviation from the standard in laboratory tests
5. The man whose eGFR is under 60
6. The man who has abnormal finding in ECG, brain MRI and vital signs
7. The man who is positive in infectious disease test
8. The man who can not undergo MRI and PET examination by reasons of metal inside the body, tattoos and claustphobia
9. The man who participates in clinical trial where he underwent nuclear medicine scan or CT scan within 6 months
10. The man who donates his blood 400ml within 12 weeks or 200ml within 4 weeks or more little within 2 weeks
11. The man who participates in other clinical trial within 3 months
12. The man who continues and cannot quit using drugs
13. The man who is suspected of alcohol hypersensitivity
14. The man who can not avoid impregnating during this trial
15. The man who is judged inadequate by the research medical doctor

(Exclusion criteria at the stage of pre-PET test)
1. The man who shows deviation from the standard in laboratory tests
2. The man who has abnormal finding in vital signs
3. The man who is judged inadequate by the research medical doctor

Target sample size

12


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tomoyuki Miyazaki

Organization

Yokohama City University hospital

Division name

Department of Physiology /Anesthesiology

Zip code


Address

3-9 Fukuura, Kanazawa-ward, Yokohama 236-0004

TEL

045-787-2579

Email

johney@yokohama-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name sayoko nakashima

Organization

Yokohama City University

Division name

Y-NEXT

Zip code


Address

1-1-1 Fukuura, Kanazawa-ward, Yokohama 236-0004

TEL

045-370-7994

Homepage URL


Email

sayoko_n@yokohama-cu.ac.jp


Sponsor or person

Institute

Yokohama City University

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Other

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

2017 Year 03 Month 06 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

Completed

Date of protocol fixation

2017 Year 02 Month 17 Day

Date of IRB


Anticipated trial start date

2017 Year 03 Month 06 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete

2017 Year 10 Month 30 Day

Date analysis concluded

2018 Year 02 Month 16 Day


Other

Other related information



Management information

Registered date

2017 Year 03 Month 01 Day

Last modified on

2018 Year 08 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030285


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name