Evaluation and Validation of Metabolic Markers for the Assessment of CYP3A Activity and Prediction of DDI

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: Male

Summary

Evaluation and validation of metabolic markers for the assessment of CYP3A activity and prediction of drug-drug interaction in Korean healthy subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Hydroxyitraconazole; Itraconazole; Midazolam; Rifampin

Criteria

Inclusion Criteria:

• Age: Between 20 to 40 years of age, inclusive

• Weight: within 17-28 of Body Mass Index (BMI)

• Subject who are reliable and willing to make themselves available during the study period, are willing to follow the study protocol, and give their written informed consent voluntarily

Exclusion Criteria:

• History of hypersensitive reaction to medication (midazolam, itraconazole, rifampicin)

• History of significant clinical illness needs medical caution, including cardiovascular, immunologic, hematologic, neuropsychiatric, respiratory, gastrointestinal, hepatic, or renal disease or other chronic disease

• History or evidence of drug abuse

• Use any prescriptive medication, Korean traditional medication not considered acceptable by the clinical investigator during the last 14 days period before first dosing, or use any medication not considered acceptable by the clinical investigator during the last 7 days period before first dosing (if used medication is considered acceptable by investigator, patients can be included)

• Participation in clinical trials of any drug within 60 days prior to the participation of the study

• Judged to be inappropriate for the study by the investigator