A phase 1 clinical pharmacological study with repeated oral doses of KAG-308
- Conditions
- lcerative Colitis
- Registration Number
- JPRN-UMIN000014009
- Lead Sponsor
- Kaken Pharmaceutical Co., LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 30
Not provided
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 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. 13. The subject who participated in the clinical trial of KAG-308 in the past, and take a dose of study drug.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 pharmacokinetic parameters 2. Urinary concentration of KAG-308 and the metabolites, and the excretion rate 3. Search for plasma unknown metabolites
- Secondary Outcome Measures
Name Time Method