UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021672
Receipt No. R000024990
Scientific Title Single dose study of GT863 in Japanese male healthy adult subjects
Date of disclosure of the study information 2016/04/05
Last modified on 2016/06/15

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Single dose study of GT863 in Japanese male healthy adult subjects
Acronym GT863 single dose study
Scientific Title Single dose study of GT863 in Japanese male healthy adult subjects
Scientific Title:Acronym 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

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

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
1st name
Middle name
Last name Setsuo Hasegawa
Organization Pharmaspur Inc.
Division name Internal medicine
Zip code
Address 1-2-10 Nihonbashi,Chuo-ku,Tokyo,Japan
TEL 03-6214-2670
Email setsuo_hasegawa@pharmaspur.com

Public contact
Name of contact person
1st name
Middle name
Last name Ayaka Kiyota
Organization Pharmaspur Inc.
Division name Clinical study
Zip code
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

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)

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
2016 Year 04 Month 05 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
2016 Year 03 Month 23 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.