UMIN-CTR Clinical Trial

Public title

Single-dose study to examine the pharmacokinetics of the L-arginine for healthy adults

Acronym

Single-dose study to examine the pharmacokinetics of the L-arginine for healthy adults

Scientific Title

Single-dose study to examine the pharmacokinetics of the L-arginine for healthy adults

Scientific Title:Acronym

Single-dose study to examine the pharmacokinetics of the L-arginine for healthy adults

Region

Japan

Condition

healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the safety and efficacy of L-arginine for healthy adults

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

-Efficacy:
Change in walking speed as measured by 10 meter walk test from Day 0 to Day 7 (time and number of steps)

Key secondary outcomes

-Safety:
Adverse event (frequency and severity)
Effect on Endocrine (To reveal the endocrine on behalf of growth hormone on Day 0,7,14,28)
Effect on metabolism (To reveal the metabolism on behalf of lactic acid, pyruvic acid and blood gas analysis on Day 0,7,14,28)
Effect on immunity (To reveal the immunity on behalf of cytokine and chemokine on Day 0,7,14,28)

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No need to know

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Take 20g of Argi-U Granule 3-4 times a day for 7 days consecutively

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

(1) Subjects must have signed an informed consent form at age 20 or older
(2) Subjects must have voluntarily signed written informed consent to participate in the study
And also, subjects who desire to only investigate the end point without taking Argi-U Granule after understanding purpose of this study
(3) Subjects who can and plan to visit the hospital according to the study schedule

Key exclusion criteria

(1) Subjects who have participated in interventional studies within 16 weeks prior to signing the patient informed consent
(2) Subjects who have history disease such as endocrine/metabolic disease, autoimmune disorder and immunodeficiency affects the secondary end point
(3) Subjects with serious complications such as heart failure, lung diseases, kidney failure, liver failure and uncontrolled diabetes
(4) Subjects with cancer or history of cancer
(5) Subjects or breast-feeding women, women suspected of being pregnant and patients who do not consent to prevent conception by taking appropriate means with the assistance of their partners during the study period
(6) Subjects considered unsuitable for participation in the study by the principal investigators or sub-investigators

Target sample size

10

Name of lead principal investigator

1st name
Middle name
Last name	Hiroshi Takashima

Organization

Kagoshima University Hospital

Division name

Department of Neurology

Zip code

Address

8-35-1 Sakuragaoka, Kagoshima City, Kagoshima 890-8520, Japan

TEL

099-275-5332

Email

thiroshi@m3.kufm.kagoshima-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Eiji Matsuura

Organization

Kagoshima University Hospital

Division name

Department of Neurology

Zip code

Address

8-35-1 Sakuragaoka, Kagoshima City, Kagoshima 890-8520, Japan

TEL

099-275-5332

Homepage URL

Email

pine@m.kufm.kagoshima-u.ac.jp

Institute

Kagoshima University Hospital

Institute

Department

Personal name

Organization

The Research on Measures for Intractable Diseases Project of Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

鹿児島大学病院（鹿児島）

Date of disclosure of the study information

2016

Year

11

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2016

Year

09

Month

01

Day

Date of IRB

Anticipated trial start date

2016

Year

11

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

10

Month

26

Day

Last modified on

2018

Year

10

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028277