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

Healthy Volunteers Clinical Trial

— CYP3A_basal  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02579434
• Other study ID #: CYP3A_basal
• Status: Completed
• Phase: Phase 1
• First received: December 23, 2014
• Last updated: April 15, 2016
• Start date: December 2014
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: April 2016
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Midazolam I.V.
Midazolam I.V. 1mg/ml

Locations

Country	Name	City	State
Korea, Republic of	Jieon Lee	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve of midazolam (AUC12h)	Pharmacokinetics of midazolam	Up to 12 hours after midazolam administration	No
Primary	Metabolic ratio of steroids	endogenous metabolite profiles such as steroid (6beta-hydroxy-cortisol/cortisol, 6beta-hydroxy-cortisone/cortisone)	12h-12h	No
Primary	Clearance (CL) of midazolam	Pharmacokinetics of midazolam	Up to 12 hours after midazolam administration	No