Ulcerative Colitis
Conditions
Interventions
KAG-308 40 ug
KAG-308 80 ug
KAG-308 160 ug
Placebo
Sponsors
Kaken Pharmaceutical Co., LTD
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Weight 50 kg or more 2. BMI 18.5 or more, and less than 25.0 3. Japanese
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactKaken Pharmaceutical Co., LTD
Kaken Pharmaceutical Co., LTD Clinical Development Department
Outcome results
None listed