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

NCT ID: NCT02328443

Last Updated: 2016-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-04-30

Brief Summary

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

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 4 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 12 hour before and 24 hour after midazolam administration. Subjects will be dosed study drug via intravenous around at 9 a.m. of Day 1. Subjects performed scheduled procedures.

In period 2, Subjects will be admitted on Day 3-5. Subjects performed scheduled period 2 (Itraconazole co-administration phase, 2 times administration of itraconazole 200 mg), and period 3 (rifampicin 150 mg co-administration phase) procedure. Study participation was terminated on post-study visit (Day 23~35).

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

midazolam alone

midazolam administration alone

Group Type: EXPERIMENTAL

Midazolam

Intervention Type: DRUG

midazolam and itraconazole

Itraconazole 200 mg PO twice; midazolam iv single administration

Group Type: EXPERIMENTAL

Midazolam

Intervention Type: DRUG

itraconazole

Intervention Type: DRUG

midazolam and rifampicin

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

Group Type: EXPERIMENTAL

Midazolam

Intervention Type: DRUG

rifampicin

Intervention Type: DRUG

Interventions

Midazolam

Intervention Type: DRUG

itraconazole

Intervention Type: DRUG

rifampicin

Intervention Type: DRUG

Other Intervention Names

Bukwang Midazolam, Korea

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Joo-Youn Cho

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

CYP3A_weak

Identifier Type: -

Identifier Source: org_study_id