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

NCT02328443 | Completed Phase 1

• 1 other identifier: CYP3A_weak
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Keywords

CYP3A; Metabolomics

Outcome Measures

Primary Outcomes (2)

• Quantitation of endogenous metabolites

  endogenous metabolite profiles such as steroids to predict CYP3A activity

  -12h-24h

• Maximum plasma concentration and area under the cure from zero to last point

  Cmax, AUClast of midazolam

  Time Frame: 0h, 10m, 20m, 30m, 45m, 1h, 2h, 3h, 4h, 6h, 8h, 12h

Study Arms (3)

midazolam alone

EXPERIMENTAL

midazolam administration alone

Drug: Midazolam

midazolam and itraconazole

EXPERIMENTAL

Itraconazole 200 mg PO twice; midazolam iv single administration

Drug: Midazolam; Drug: itraconazole

midazolam and rifampicin

EXPERIMENTAL

rifampicin 150 mg PO for 9 days administration, midazolam iv single administration

Drug: Midazolam; Drug: rifampicin

Interventions

Midazolam DRUG

Also known as: Bukwang Midazolam, Korea

midazolam alone; midazolam and itraconazole; midazolam and rifampicin

itraconazole DRUG

midazolam and itraconazole

rifampicin DRUG

midazolam and rifampicin

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

MeSH Terms

Interventions

Midazolam; Itraconazole; Rifampin

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Piperazines; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 23, 2014
• First Posted: December 31, 2014
• Study Start: January 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: April 19, 2016

Record last verified: 2016-04