Ulcerative Colitis
Conditions
Interventions
1. AJM300 960 mg orally 3 times daily for 14days
2. On the day before AJM300, 7days, 14 days, 28 days and 42 days after AJM300, midazolam 5 mg once daily orally with AJM300 960 mg orally 3 times daily
Sponsors
Takeuchi Yutaka
Kissei Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. A Japanese healthy male adult aged from 20 to less than 46 inclusive at the time of written informed consent 2. A BMI meeting the following criterion at screening: Japanese subjects, >= 18.5 and < 25.0 kg/m2 3. Judging by the investigator or sub-investigator to have no significant clinically relevant abnormalities in examination findings, physiological tests, and laboratory tests, and who have no problem participating in this study 4. Consenting in writing to participate in this clinical study on his own free will and able to comply with the requirements in the clinical study
Exclusion criteria
Exclusion criteria: 1. History or complication at screening or any physical finding, vital sign, ECG finding, or laboratory value at screening or baseline that raises suspicion of a clinically abnormal symptom or organ dysfunction that requires treatment 2. Subjects who are contraindicated to administer the concomitant drug according to the current label of the drug. 3. Subjects who have a white blood cell count of 4000/uL or less at screening and on the day of hospitalization (sequence 1 to 4: day -2, sequence 5: day -1) 4. Subjects who took grapefruit, grapefruit juice and foods containing these ingredients within 8 days before the start of the clinical trial and St. John's wort and their ingredients within 15 days before the start of the clinical trial. 5. Anyone deemed ineligible to participate in this clinical study by the investigator or sub investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: AEs, Laboratory tests, Vital signs, 12-lead ECGs, Physical findings Pharmacokinetics: Plasma AJM300, AJM300 related metabolites, midazolam, atorvastatin and prednisolone concentration | — |
Contacts
Public ContactYutaka Takeuchi
EA Pharma Co., Ltd
Outcome results
None listed