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

Phase 1

• Conditions: lcerative Colitis

• Registration Number: JPRN-jRCT2071230023
• Lead Sponsor: Takeuchi Yutaka

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-06-19
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 88

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified