UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Single dose study of GT863 in Japanese male healthy adult subjects
Title of the study (Brief title)	GT863 single dose study
Region	Japan

Condition
Condition	Alzheimer's disease
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Primary objective Investigation for safety of GT863 in male healthy adult subjects. Secondary objective Investigation for pharmacokinetics of GT863
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Safety of GT863 Vital sign (Pre, 2, 24hours, Follow up(7days)) Electrocardiogram (Pre, 2, 24hours, Follow up(7days)) laboratory examination (Pre, 2, 24hours, Follow up(7days)) adverse event
Key secondary outcomes	Pharmacokinetics of GT863

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	Treatment
Type of intervention	Medicine
Interventions/Control_1	GT863(0.3, 1.0 mg , single dose)
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	45 years-old >=
Gender	Male
Key inclusion criteria	(1)Japanese male healthy adult subjects (2)between 20 and 45 years inclusive (3)Body weight over 50 kg (4)BMI over 18.5, under 25.0kg/m2 (5)Having given written informed consent prior to any procedure related to the study.
Key exclusion criteria	(1) Any subject who have present and/or past history of disease of heart and circulatory system, liver, kidney, digestive system, and blood system, central nerves system, respiratory system. (2) Hypersensitivity or Idiosyncratic to drugs (3) History of allergy to any clinically important allergy (4) Aany subject have present and/or past history of drug and alcohol addiction. (5) Positive serologic findings for treponema pallidum (syphilis), human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg),and/or hepatitis C virus (HCV) antibodies. (6) Positive findings of urine drug screen. (7) Any drug history within 2weeks before study day 1. (8) Use of any investigational drug within 16weeks before study day 1. (9) Donation of blood over 400mL within 14 weeks, 200mL within 4weeks before study day 1. Blood compornent donation within 2weeks. (10) Any subject not able to agree to make contraception during the study. (11) Any clinically important deviation from normal limits in physical examination, vital signs, 12-lead electrocardiograms (ECGs), or clinical laboratory test results. (12) Subjects deemed by the investigator to be inappropriate according for inclusion in the study.
Target sample size	12

Research contact person
Name of lead principal investigator	Setsuo Hasegawa
Organization	Pharmaspur Inc.
Division name	Internal medicine
Address	1-2-10 Nihonbashi,Chuo-ku,Tokyo,Japan
TEL	03-6214-2670
Email	setsuo_hasegawa@pharmaspur.com

Public contact
Name of contact person	Ayaka Kiyota
Organization	Pharmaspur Inc.
Division name	Clinical study
Address	1-2-10 Nihonbashi,Chuo-ku,Tokyo,Japan
TEL	03-6214-2670
Homepage URL
Email	ayaka_kiyota@pharmaspur.com

Sponsor
Institute	Tokyo Heart Center
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	GreenTec co.,Ltd.
Organization
Division
Category of Funding Organization	Profit organization
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

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 23 Day
Anticipated trial start date	2016 Year 04 Month 05 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 03 Month 29 Day
Last modified on	2016 Year 06 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024990