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

NCT01215214 | Completed Phase 1

• 1 other identifier: SNUCPT10_CYP3A
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

metabolite profiles; pharmacokinetics; CYP3A; metabolomics

Outcome Measures

Primary Outcomes (1)

• Metabolomic profile

  endogenous metabolite profiles such as steroids

  -24- -12h, -12- 0h of every midazolam dosing

Secondary Outcomes (1)

• Pharmacokinetics

  0h, 10m, 20m, 30m, 45m, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h

Study Arms (1)

midazolam

EXPERIMENTAL

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

Interventions

midazolam DRUG

midazolam: 3mg iv

Also known as: Bukwang midazolam, Korea

midazolam

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Ministry of Education Science and Technology, Korea: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Joo-Youn Cho, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 4, 2010
• First Posted: October 6, 2010
• Study Start: October 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: January 1, 2011
• Last Updated: February 23, 2011

Record last verified: 2011-02

Locations

KR (1)