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Evaluation and Validation of Metabolic Markers for the Assessment of CYP3A Activity and Prediction of DDI (CYP3A_weak)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02328443
Recruitment Status : Completed
First Posted : December 31, 2014
Last Update Posted : April 19, 2016
Information provided by (Responsible Party):
Joo-Youn Cho, Seoul National University Hospital

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Midazolam Drug: itraconazole Drug: rifampicin Phase 1

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 4 weeks before study drug administration. Subjects suitable for this study will be admitted to the Clinical Trials Center, Seoul National University Hospital on the day before dosing, and they were overnight-fasted from 10 p.m. of Day -1. Urine collection is scheduled drug 12 hour before and 24 hour after midazolam administration. Subjects will be dosed study drug via intravenous around at 9 a.m. of Day 1. Subjects performed scheduled procedures.

In period 2, Subjects will be admitted on Day 3-5. Subjects performed scheduled period 2 (Itraconazole co-administration phase, 2 times administration of itraconazole 200 mg), and period 3 (rifampicin 150 mg co-administration phase) procedure. Study participation was terminated on post-study visit (Day 23~35).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Evaluation and Validation of Metabolic Markers for the Assessment of CYP3A Activity and Prediction of Drug-drug Interaction in Korean Healthy Subjects
Study Start Date : January 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: midazolam alone
midazolam administration alone
Drug: Midazolam
Other Name: Bukwang Midazolam, Korea

Experimental: midazolam and itraconazole
Itraconazole 200 mg PO twice; midazolam iv single administration
Drug: Midazolam
Other Name: Bukwang Midazolam, Korea

Drug: itraconazole
Experimental: midazolam and rifampicin
rifampicin 150 mg PO for 9 days administration, midazolam iv single administration
Drug: Midazolam
Other Name: Bukwang Midazolam, Korea

Drug: rifampicin

Primary Outcome Measures :
  1. Quantitation of endogenous metabolites [ Time Frame: -12h-24h ]
    endogenous metabolite profiles such as steroids to predict CYP3A activity

  2. Maximum plasma concentration and area under the cure from zero to last point [ Time Frame: Time Frame: 0h, 10m, 20m, 30m, 45m, 1h, 2h, 3h, 4h, 6h, 8h, 12h ]
    Cmax, AUClast of midazolam

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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
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Responsible Party: Joo-Youn Cho, Professor, Seoul National University Hospital Identifier: NCT02328443    
Other Study ID Numbers: CYP3A_weak
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: April 19, 2016
Last Verified: April 2016
Keywords provided by Joo-Youn Cho, Seoul National University Hospital:
Additional relevant MeSH terms:
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Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Cytochrome P-450 CYP3A Inhibitors
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Leprostatic Agents