Drug-Drug interaction study of AJM300(1) - Combination clinical pharmacology study of oral midazolam, oral prednisolone, oral atorvastatin and intravenous midazolam in healthy male subjects -

JRCT ID: jRCT2071230023

Registered date:19/06/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Ulcerative Colitis
• Date of first enrollment: 05/11/2015
• Target sample size: 88
• Study type: Interventional

Intervention(s)

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 for 14days
3. On the day before AJM300, 7days, 14 days, 28 days and 42 days after AJM300, prednisolone 5 mg onc daily orally with AJM300 960 mg orally 3 times daily for 14days
4. On the day before AJM300, 7days, 14 days, 28 days and 42 days after AJM300, atorvastatin 10mg once daily orally with AJM300 960 mg orally 3 times daily for 14days
5. On the day before AJM300, 7days, 14 days, 28 days and 42 days after AJM300, midazolam 5 mg/mL 0.0034 mL/kg once daily orally with AJM300 960 mg intravenously 3 times daily for 14days

Outcome(s)

Primary Outcome

Safety: AEs, Laboratory tests, Vital signs, 12-lead ECGs, Physical findings
Pharmacokinetics: Plasma AJM300, AJM300 related metabolites, midazolam, atorvastatin and prednisolone concentration

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 46age old
• Gender: Male

Include 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

Exclude 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

Related Information

• Primary Sponsor: Takeuchi Yutaka
• Secondary Sponsor: Kissei Pharmaceutical Co., Ltd.