Unique ID issued by UMIN | UMIN000021672 |
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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 |
Single dose study of GT863 in Japanese male healthy adult subjects
GT863 single dose study
Single dose study of GT863 in Japanese male healthy adult subjects
GT863 single dose study
Japan |
Alzheimer's disease
Neurology |
Others
NO
Primary objective
Investigation for safety of GT863 in male healthy adult subjects.
Secondary objective
Investigation for pharmacokinetics of GT863
Safety
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
Pharmacokinetics of GT863
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
GT863(0.3, 1.0 mg , single dose)
20 | years-old | <= |
45 | years-old | >= |
Male
(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.
(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.
12
1st name | |
Middle name | |
Last name | Setsuo Hasegawa |
Pharmaspur Inc.
Internal medicine
1-2-10 Nihonbashi,Chuo-ku,Tokyo,Japan
03-6214-2670
setsuo_hasegawa@pharmaspur.com
1st name | |
Middle name | |
Last name | Ayaka Kiyota |
Pharmaspur Inc.
Clinical study
1-2-10 Nihonbashi,Chuo-ku,Tokyo,Japan
03-6214-2670
ayaka_kiyota@pharmaspur.com
Tokyo Heart Center
GreenTec co.,Ltd.
Profit organization
NO
2016 | Year | 04 | Month | 05 | Day |
Unpublished
Completed
2016 | Year | 03 | Month | 23 | Day |
2016 | Year | 04 | Month | 05 | Day |
2016 | Year | 03 | Month | 29 | Day |
2016 | Year | 06 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024990
Research Plan | |
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Research case data | |
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