UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030940
Receipt number R000035333
Scientific Title Open-label study on safety and pharmacokinetics of [11C]thiamine in normal subjects
Date of disclosure of the study information 2018/01/23
Last modified on 2020/01/24 09:31:45

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Basic information

Public title

Open-label study on safety and pharmacokinetics of [11C]thiamine in normal subjects

Acronym

PET pharmacokinetics of [11C]thiamine

Scientific Title

Open-label study on safety and pharmacokinetics of [11C]thiamine in normal subjects

Scientific Title:Acronym

PET pharmacokinetics of [11C]thiamine

Region

Japan


Condition

Condition

Normal subjects

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of safety, dosimetry and whole-body pharmacokinetics of [11C]thiamine

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase I


Assessment

Primary outcomes

Safety (ECG, blood count, blood chemistry, urine at 90 min post injection)

Key secondary outcomes

Radiation exposure dosimetry

Whole-body pharmacokinetics for 90min


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

PET imaging for 90min with single intravenous injection of [11C]thiamine (30-400MBq), which takes 4 hours in total including preparation and safety examinations.

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

65 years-old >

Gender

Male

Key inclusion criteria

1.Informed consent
2.Japanese male of 20y.o. or older and younger than 65y.o.
3.Body weight being 50kg or higher and lower than 85kg. BMI being 18.5 or higher and lower than 26.5
4.Healthy enough for this study

Key exclusion criteria

1)Allergy to drugs and/or foods
2)Serious disease in liver, kidney, heart, blood or vascular system.
3)Medication or dietary supplement within 7 days prior to PET scan.
4)Habitual intake of drugs or dietary supplements containing vitamin B1 or derivatives. Such intake within 1 month prior to PET scan.
5)Habitual heavy alcohol drinker or such intake within 7 days prior to PET scan.
6)Blood donation of 200mL or more within 1 month, 400mL or more within 3months
7)Should avoid further radiation exposure, based on radiation exposure history
8)Syphilis, HIV, Hepatitis B or C infection
9)Drug or alcohol abuse.
10)Inappropriate for a subject of this study for other reasons

Target sample size

3


Research contact person

Name of lead principal investigator

1st name Michio
Middle name
Last name Senda

Organization

Kobe City Medical Center General Hospital

Division name

Molecular Imaging Research Group, Center for Clinical Research and Innovation

Zip code

650-0047

Address

2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe 650-0047 Japan

TEL

078-304-5212

Email

michio_senda@kcho.jp


Public contact

Name of contact person

1st name Kiyoshi
Middle name
Last name Irikura

Organization

Kobe City Medical Center General Hospital

Division name

Center for Clinical Research and Innovation

Zip code

650-0047

Address

2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe 650-0047 Japan

TEL

078-304-5212

Homepage URL


Email

irikura@fbri.org


Sponsor or person

Institute

Kobe City Medical Center General Hospital,

Center for Clinical Research and Innovation

Institute

Department

Personal name



Funding Source

Organization

Takeda Consumer Healthcare Company Limited

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Riken

Name of secondary funder(s)

Foundation for Biomedical Research and Innovation


IRB Contact (For public release)

Organization

Kobe City Medical Center General Hospital IRB

Address

2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe 650-0047 Japan

Tel

078-302-4321

Email

rinken@kcho.jp


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

神戸市立医療センター中央市民病院(兵庫県)


Other administrative information

Date of disclosure of the study information

2018 Year 01 Month 23 Day


Related information

URL releasing protocol

https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000035333

Publication of results

Unpublished


Result

URL related to results and publications

Unpublished

Number of participants that the trial has enrolled

3

Results

No adverse effects.
Data acquisition was completed and was fixed.

Results date posted

2019 Year 07 Month 25 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Normal subjects.

Participant flow

The subjects were enrolled after screening tests.

Adverse events

No adverse effects.

Outcome measures

Data analysis is on-going about evaluation of whole-body distribution and pharmacokinetics of [11C]thiamine together with dosimetry.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 12 Month 19 Day

Date of IRB

2018 Year 01 Month 18 Day

Anticipated trial start date

2018 Year 01 Month 24 Day

Last follow-up date

2018 Year 03 Month 26 Day

Date of closure to data entry

2018 Year 04 Month 10 Day

Date trial data considered complete

2018 Year 04 Month 24 Day

Date analysis concluded

2020 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2018 Year 01 Month 22 Day

Last modified on

2020 Year 01 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035333


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name