Identification and Evaluation of Endogenous Markers for the Assessment of CYP3A Activity

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

Identification and evaluation of endogenous markers for the assessment of CYP3A activity in female subjects using metabolomics

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

Details

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

Criteria

Inclusion Criteria:

• Age: Between 20 to 50 years of age, inclusive

• Weight: Between 45 to 95 kg, within 17 - 28 of Body Mass Index

• Menstruation cycle between 21 to 35 without contraceptive

• Subject who agree contraception during the study

• 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, ketoconazole, 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

• A subject whose lab test results are as follows; Liver function test (AST, ALT, GGT, ALP, LDH, Total bilirubin) > 1.25 X upper limit of reference range

• A subject whose SBP is over 140 mmHg or below 90 mmHg and DBP is over 100 mmHg or below 50 mmHg

• Presence or history of drug abuse or positive result in urine drug screening test

• Blood donation during 2 months or apheresis during 1 month before the study

• 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 OTC 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)

• Use of alcohol over 21 units/weeks

• Smoker who smoke more than 10 cigarettes per day

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

• Use of grapefruit juice within 1 week before first dose

• Use of caffeine drink within 3 days before first dose

• Subject pregnant or breast-feeding

• Judged to be inappropriate for the study by the investigator