Unique ID issued by UMIN | UMIN000020337 |
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Receipt number | R000023491 |
Scientific Title | Clinical pharmacological study of TM5509 -Clinical pharmacological study in male mild obesity subjects (additional test)- |
Date of disclosure of the study information | 2016/01/08 |
Last modified on | 2016/09/28 09:59:07 |
Clinical pharmacological study of TM5509
-Clinical pharmacological study in male mild obesity subjects (additional test)-
Clinical pharmacological study of TM5509
-Clinical pharmacological study in male mild obesity subjects (additional test)- (TM5509-7)
Clinical pharmacological study of TM5509
-Clinical pharmacological study in male mild obesity subjects (additional test)-
Clinical pharmacological study of TM5509
-Clinical pharmacological study in male mild obesity subjects (additional test)- (TM5509-7)
Japan |
Recover of hematogenesis after cord blood transplantation
Hematology and clinical oncology |
Others
YES
Primary objective
Investigation for pharmacodynamics of TM5509 in Japanese male mild obesity subjects.
Secondary objective
Investigation for safety and pharmacokinetics of TM5509.
Pharmacodynamics
Exploratory
Phase I
Pharmacodynamics of TM5509
Safety and Pharmacokinetics of TM5509
Interventional
Cross-over
Randomized
Individual
Single blind -participants are blinded
Placebo
2
Treatment
Medicine |
step1
TM5509 (180mg, once a day for 3days)
washout period more than 3weeks
step2
placebo (once a day for 3days)
step1
placebo (once a day for 3days)
washout period more than 3weeks
step2
TM5509 (180mg, once a day for 3days)
20 | years-old | <= |
45 | years-old | > |
Male
1. Male Japanese
2. From 20 years old to 45 years old at voluntary written consent
3. From 65.0 kg to 90.0 kg and from 25.0 to 30.0 of BMI at screening
4. More than 20ng/ml of total PAI-1
5. Voluntary written consent by themselves is given before screening
1. History of liver diseases, cardiovascular diseases, respiratory diseaases, gastroenteric diseases, kidney diseases, cerebralvascular diseases, cancer
2. Known hypersensitivity to some drugs and foods
3. More than grade 1 in liver function disorders
4. Treatment by other doctors (included supplement) within 14 days before screening
5. Treatment with any investigational compound within 120 days before screening
6. History of TM5509 administration
7. History of blood taken
*>= 1200ml of all blood within 1 year before screening
*>= 400ml of all blood with 84 days before screening
*>= 200ml of all blood within 14 days before screening
8. Smoking status and treatment with anti-nicotine agents
9. Known active chronic hepatitis B or C, active syphilis and human immunodeficiency virus infection
10. Abuse of alcohol or drugs (included past history)
11. Bleeding, in the tendency to bleeding, and family history and past history of bleeding disorders
12. Somebody who are directed by principle investigator and employees in Hamamatsu University hospital
13. Any serious medical or psychiatric illness that could, in the opinion of the investigator, potentially interfere with the completion of treatment according to this protocol.
10
1st name | |
Middle name | |
Last name | Kazuo Umemura |
Hamamatsu University Hospital
Center for clinical research
1-20-1 Handayama Higashi-ku, Hamamatsu, Japan
053-434-6587
umemura@hama-med.ac.jp
1st name | |
Middle name | |
Last name | Kazuo Umemura |
Hamamatsu University Hospital
Center for clinical research
1-20-1 Handayama Higashi-ku, Hamamatsu, Japan
053-434-6587
http://hama-ccr.jp/tr/
umemura@hama-med.ac.jp
Tohoku university school of medicine, molecular medicine and therapy, Toshio Miyata
ministry of health, labour and welfare
Japanese Governmental office
Japan
NO
2016 | Year | 01 | Month | 08 | Day |
Unpublished
Completed
2016 | Year | 01 | Month | 08 | Day |
2016 | Year | 01 | Month | 27 | Day |
2015 | Year | 12 | Month | 25 | Day |
2016 | Year | 09 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023491
Research Plan | |
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