UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021672 |
|---|---|
| Receipt number | 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 07:51:00 |
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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
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
ayaka_kiyota@pharmaspur.com
Sponsor or person
Institute
Tokyo Heart Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024990
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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