Identification and Evaluation of Endogenous Markers for the Assessment of CYP3A Activity
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ClinicalTrials.gov Identifier: NCT01760642 |
Recruitment Status :
Completed
First Posted : January 4, 2013
Last Update Posted : May 26, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: Midazolam Drug: Ketoconazole Drug: Rifampicin | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 16 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Identification and Evaluation of Endogenous Markers for the Assessment of CYP3A Activity in Female Subjects Using Metabolomics |
Study Start Date : | December 2012 |
Actual Primary Completion Date : | September 2013 |
Actual Study Completion Date : | September 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: Midazolam
period 1: midazolam 1 mg IV single dose administration. period 2: midazolam 1 mg IV single dose after ketoconazole 400 mg oral dosing for 3 days. period 3: midazolam 2.5 mg IV single dose after rifampicin 600 mg oral dosing for 10 days. |
Drug: Midazolam
Midazolam 3 mg IV
Other Name: Midazolam (Bukwang Pharm.Co., Ltd.) Drug: Ketoconazole ketoconazole 400 mg PO
Other Name: Kaszole (Skynewpharm Inc.) Drug: Rifampicin Rifampicin 600 mg PO
Other Name: Rifampin (Yuhan Corp.) |
- Metabolomic profile [ Time Frame: -24--12h, -12-0h of every midazolam dosing ]endogenous metabolite profiles such as steroid
- Pharmacokinetics [ Time Frame: 0h, 10m, 20m, 30m, 45m, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h of every midazolam dosing ]Cmax, AUClast of midazolam

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Ages Eligible for Study: | 20 Years to 50 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01760642
Korea, Republic of | |
Seoul National Universtiy Hospital | |
Seoul, Korea, Republic of, 110-744 |
Principal Investigator: | Joo-Youn Cho, PhD | Seoul National University Hospital |
Responsible Party: | Joo-Youn Cho, Professor, Seoul National University Hospital |
ClinicalTrials.gov Identifier: | NCT01760642 |
Other Study ID Numbers: |
CYP_metabolomics |
First Posted: | January 4, 2013 Key Record Dates |
Last Update Posted: | May 26, 2014 |
Last Verified: | May 2014 |
metabolite profiles pharmacokinetics CYP3A metabolomics |
Rifampin Ketoconazole Midazolam Adjuvants, Anesthesia Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Anti-Anxiety Agents Tranquilizing Agents Psychotropic Drugs Anesthetics, Intravenous Anesthetics, General Anesthetics GABA Modulators GABA Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antibiotics, Antitubercular Antitubercular Agents Anti-Bacterial Agents Anti-Infective Agents Leprostatic Agents Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP2C8 Inducers Cytochrome P-450 CYP2C19 Inducers Cytochrome P-450 CYP2C9 Inducers Cytochrome P-450 CYP3A Inducers |