Evaluation and Validation of Endogenous Markers for the Assessment of CYP3A Activity in Korean Healthy Subjects Using Metabolomics

NCT ID: NCT02579434

Last Updated: 2016-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2016-04-30

Brief Summary

The study objective is to evaluate and validate of endogenous markers for the assessment of CYP3A activity in Korean healthy subjects using metabolomics.

In part 1, total 75 healthy subjects (males and females) will be enrolled. In part 2, total 25 healthy female subject aged 20-45 years will be enrolled. In both part A and B, subjects will be administered midazolam I.V. 1 mg.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Male young adults

Arm 1: Male healthy volunteers aged from 20 to 45 years Midazolam (IV) on day 1

Group Type: EXPERIMENTAL

Midazolam I.V.

Intervention Type: DRUG

Midazolam I.V. 1mg/ml

Male elderly adults

Arm 2: Male healthy volunteers aged over 45 years Midazolam (IV) on day 1

Group Type: EXPERIMENTAL

Midazolam I.V.

Intervention Type: DRUG

Midazolam I.V. 1mg/ml

Female elderly adults

Arm 3: Female healthy volunteers aged over 45 years Midazolam (IV) on day 1

Group Type: EXPERIMENTAL

Midazolam I.V.

Intervention Type: DRUG

Midazolam I.V. 1mg/ml

Female young adults

Arm 4: Female healthy volunteers aged 20 to 45 years Midazolam (IV) on day 1, Day 15

Group Type: EXPERIMENTAL

Midazolam I.V.

Intervention Type: DRUG

Midazolam I.V. 1mg/ml

Interventions

Midazolam I.V.

Midazolam I.V. 1mg/ml

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age: Between 20 to 80 years of age, inclusive
• Weight: Between 45 to 95 kg, within 17 - 28 of Body Mass Index
• Subject who agree contraception during the study
• 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
• A subject whose lab test results are abnormal A subject whose systolic blood pressure is over 140 mmHg or below 90 mmHg and diastolic blood pressure is over 100 mmHg or below 50 mmHg
• Presence or history of drug abuse or positive result in urine drug screening test
• Blood donation during 2 months or apheresis during 1 month before the study Use any prescriptive medication
• Use of alcohol over 21 units/weeks
• Smoker who smoke more than 10 cigarettes per day
• Participation in clinical trials of any drug within 60 days prior to the participation of the study
• Use of grapefruit juice within 1 week before first dose
• Use of caffeine drink within 3 days before first dose
• Subject pregnant or breast-feeding
• Judged to be inappropriate for the study by the investigator

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Joo-Youn Cho

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Jieon Lee

Seoul, , South Korea

Countries

South Korea

Other Identifiers

CYP3A_basal

Identifier Type: -

Identifier Source: org_study_id