Single dose study of GT863 in Japanese male healthy adult subjects
- Conditions
- Alzheimer's disease
- Registration Number
- JPRN-UMIN000021672
- Lead Sponsor
- Tokyo Heart Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 12
Not provided
(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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Pharmacokinetics of GT863