UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Single-dose study to examine the pharmacokinetics of the L-arginine for healthy adults
Title of the study (Brief title)	Single-dose study to examine the pharmacokinetics of the L-arginine for healthy adults
Region	Japan

Condition
Condition	healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
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)

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	No need to know

Intervention
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

Eligibility
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

Research contact person
Name of lead principal investigator	Hiroshi Takashima
Organization	Kagoshima University Hospital
Division name	Department of Neurology
Address	8-35-1 Sakuragaoka, Kagoshima City, Kagoshima 890-8520, Japan
TEL	099-275-5332
Email	thiroshi@m3.kufm.kagoshima-u.ac.jp

Public contact
Name of contact person	Eiji Matsuura
Organization	Kagoshima University Hospital
Division name	Department of Neurology
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

Sponsor
Institute	Kagoshima University Hospital
Institute
Department

Funding Source
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

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	鹿児島大学病院（鹿児島）

Other administrative information
Date of disclosure of the study information	2016 Year 11 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 09 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 10 Month 26 Day
Last modified on	2018 Year 10 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028277