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

This study has been completed.
Sponsor:
Collaborator:
Ministry of Education Science and Technology, Korea
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01215214
First received: October 4, 2010
Last updated: February 19, 2011
Last verified: February 2011
History of Changes
  Purpose

Identification and evaluation of endogenous markers for the assessment of CYP3A activity using metabolomics.


Condition Intervention Phase
Healthy
 Drug: midazolam
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Identification and Evaluation of Endogenous Markers for the Assessment of CYP3A Activity Using Metabolomics

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Metabolomic profile [ Time Frame: -24- -12h, -12- 0h of every midazolam dosing ] [ Designated as safety issue: Yes ]
    endogenous metabolite profiles such as steroids


Secondary Outcome Measures:
  • Pharmacokinetics [ Time Frame: 0h, 10m, 20m, 30m, 45m, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h ] [ Designated as safety issue: Yes ]
    Cmax, AUClast of midazolam


Estimated Enrollment: 24
Study Start Date: October 2010
Study Completion Date: January 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: midazolam
period 1: midazolam administration alone period 2: ketoconazole 400 mg PO for 4 days administration, midazolam iv single administration period 3: rifampicin 600 mg PO for 9 days administration, midazolam iv single administration
 Drug: midazolam
midazolam: 3mg iv
Other Name: Bukwang midazolam, Korea

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).

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01215214

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Ministry of Education Science and Technology, Korea
Investigators
Principal Investigator: Joo-Youn Cho, PhD Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Joo-Youn Cho, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01215214     History of Changes
Other Study ID Numbers: SNUCPT10_CYP3A
Study First Received: October 4, 2010
Last Updated: February 19, 2011
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
metabolite profiles
pharmacokinetics
CYP3A
metabolomics

Additional relevant MeSH terms:
Midazolam
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
 Psychotropic Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013