Healthy
Conditions
Keywords
metabolite profiles, pharmacokinetics, CYP3A, metabolomics
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 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 24 hour before midazolam administration. Subjects will be dosed study drug via intravenous around at 9 a.m. of Day 1. Subjects performed scheduled procedures including clinical laboratory tests, electrocardiograms and pharmacokinetic samplings. Subjects will be discharged on Day 2, and visited Clinical Trials Center on Day 5-7 for ketoconazole administration. Subjects will be admitted on Day 7 for period 2. Subjects performed scheduled period 2 (ketoconazole co-administration phase), and period 3 (rifampicin co-administration phase) procedure. Study participation was terminated on post-study visit (Day 30-32).
Interventions
DRUGmidazolam
midazolam: 3mg iv
Sponsors
Ministry of Education Science and Technology, Korea
Seoul National University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Metabolomic profile | -24- -12h, -12- 0h of every midazolam dosing | endogenous metabolite profiles such as steroids |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics | 0h, 10m, 20m, 30m, 45m, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h | Cmax, AUClast of midazolam |
Countries
South Korea
Outcome results
None listed