Unique ID issued by UMIN | UMIN000011878 |
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Receipt number | R000013883 |
Scientific Title | A phase 1 clinical pharmacological study with a single oral dose of KAG-308 |
Date of disclosure of the study information | 2013/09/27 |
Last modified on | 2014/03/27 15:33:59 |
A phase 1 clinical pharmacological study with a single oral dose of KAG-308
A phase 1 clinical pharmacological study of KAG-308
A phase 1 clinical pharmacological study with a single oral dose of KAG-308
A phase 1 clinical pharmacological study of KAG-308
Japan |
Ulcerative colitis
Gastroenterology |
Others
NO
To assess the safety and pharmacokinetics of a single oral dose of KAG-308 in healthy adult male subjects.
Safety
Phase I
Safety
1. Body weight
2. Vital sign
3. Clinical test
4. Electrocardiogram
5. Adverse event
Pharmacokinetics
1. Changes over time in plasma concentration of KAG-308 and the metabolites, and pharmacokinetic parameters
2. Urinary and fecal concentration of KAG-308 and the metabolites, and the excretion rate
Interventional
Parallel
Randomized
Single blind -participants are blinded
Placebo
7
Treatment
Medicine |
KAG-308 10 ug
KAG-308 20 ug
KAG-308 40 ug
KAG-308 80 ug
KAG-308 160 ug
KAG-308 320 ug
Placebo
20 | years-old | <= |
45 | years-old | > |
Male
1. Weight:50 kg or more
2. BMI:18.5 or more, and less than 25.0
3. Japanese
1. The subject with failure or medical history of central nervous system disease, cardiac disease, or failure of cardiovascular, respiratory, blood and hematopoietic function system, gastrointestinal system, liver and renal function, thyroid function, pituitary function, adrenal function, etc. And the subject concluded by principal investigator (or sub investigators) difficult to ensure safety during the study.
2. The subject who does not meet the criteria of "clinical laboratory test, vital sign, 12 lead electrocardiograms".
3. The subject who tested positive after either HIV test, HBV test, HCV test, syphilis test, or tuberculosis test.
4. The subject with medical history of gastrointestinal tract symptom or gastrointestinal tract resection that affects pharmacokinetics.
5. The subject who is using drug or receiving therapy.
6. The subject with drug allergy or medical history.
7. The subject who felt sick at the time of blood donation or blood collection.
8. The subject who had been taken blood (blood donation, etc.) of more than 400 mL 90 days before the starting day of administration of the study drug, or the subject with the annual volume of blood collection more than 1200 mL including this study.
9. The subject who cannot stop either drinking alcohol during hospitalization or smoking from the day before the date of admission until the day of discharge.
10. The subject who tested positive on a urine abusable drug test.
11. The subject who is administered other study drug within 112 days past (16 weeks) before the scheduled administration date of the study drug.
12. The stuff of the institution or employees of the sponsor.
60
1st name | |
Middle name | |
Last name | Yuji Kumagai |
Kitasato University East Hospital
Clinical Trial Center
2-1-1, Asamizodai, Minami-ku, Sagamihara, Kanagawa, Japan
042-748-9111
kuma-guy@za2.so-net.ne.jp
1st name | |
Middle name | |
Last name | Takayuki Kinoshita |
Kaken Pharmaceutical Co., LTD
Clinical Development Department
28-8, Honkomagome 2-chome, Bunkyo-ku, Tokyo, Japan
03-5977-5111
KINOSHITA_TAKAYUKI@kaken.co.jp
Kaken Pharmaceutical Co., LTD
Kaken Pharmaceutical Co., LTD
Profit organization
NO
2013 | Year | 09 | Month | 27 | Day |
Unpublished
Completed
2013 | Year | 08 | Month | 20 | Day |
2013 | Year | 09 | Month | 29 | Day |
2013 | Year | 09 | Month | 26 | Day |
2014 | Year | 03 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013883
Research Plan | |
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