Status:
COMPLETED
Identification and Evaluation of Endogenous Markers for the Assessment of CYP3A Activity Using Metabolomics
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Ministry of Education Science and Technology, Korea
Conditions:
Healthy
Eligibility:
MALE
20-50 years
Phase:
PHASE1
Brief Summary
Identification and evaluation of endogenous markers for the assessment of CYP3A activity using metabolomics.
Detailed Description
Eligibility for participation of this study will be determined from demographic information, medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests within 3 weeks...
Eligibility Criteria
Inclusion
- Age: Between 20 to 50 years of age, inclusive
- Weight: Between 50 - 95 kg, within 17-28 of Body Mass Index
- 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
- 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
- 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)
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01215214
Start Date
October 1 2010
End Date
January 1 2011
Last Update
February 23 2011
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea, 110-744