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Influence of CYP2C19 Polymorphism on PK/PD of Omeprazole

Primary Purpose

Stomach Ulcer

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Omeprazole

About this trial

This is an interventional basic science trial for Stomach Ulcer

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Are able to provide written informed consent.
The subject is a healthy Korean aged 20 to 45 years, inclusive.
The subject weighs at least 55 (for female, 55) to 90 kg and has a body mass index (BMI) range of 18 to 25 kg/m2

Exclusion Criteria:

Subjects with evidence or a history of clinically significant pulmonary, cardiovascular, hepatic, endocrine, hematological, neurologic or psychiatric diseases.
Subjects with evidence of gastrointestinal disease which can affect the absorption of drug.
Subjects with a history of drug abuse or a positive result in the urine drug screening for drug abuse
Subjects who have taken any prescribed medicine or herbal medicine within 2 weeks before the first administration of the investigational product, any non-prescribed medicine or vitamin supplement within 1 week prior the first administration of the investigational product (if all other conditions are satisfied, subjects may be eligible for the trial as judged by the investigator.)
Subjects who have donated a unit of whole blood within 30 days or who have participated in any other clinical trial within 60 days prior the first administration of the investigational product
Subject who have history of allergy on omeprazole
Subject who can not continue proper contraception method during study period.
Subject with a positive urine HCG test result on screening. (in case of woman subject)
Subjects who consume more than 21 units of alcohol per week (1 unit = 10 g of pure alcohol) or who are unable to abstain from drinking during the PK/PD testing period
Subjects who consume more than 10 cigarette per day or who are unable to abstain from smoking during the PK/PD testing period
Subjects who are unable to abstain from grapefruit or caffeine containing food 3 day prior the first administration of the investigational product
Subjects judged not eligible for the study after reviewing the clinical laboratory results or other reasons by the investigator.

Sites / Locations

Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

CYP2C19 EM

CYP2C19 IM

CYP2C19 PM

Arm Description

CYP2C19 EM

CYP2C19 IM

CYP2C19 PM

Outcomes

Primary Outcome Measures

mean and median Intragastric PH

Secondary Outcome Measures

AUC

Cmax

Full Information

NCT ID

NCT02299687

First Posted

September 21, 2014

Last Updated

December 31, 2014

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02299687

Brief Title

Influence of CYP2C19 Polymorphism on PK/PD of Omeprazole

Official Title

A Clinical Trial to Investigate the Influence of CYP2C19 Polymorphism on Pharmacokinetic/Pharmacodynamic Characteristics of Omeprazole in Healthy Korean Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

September 2014 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Hospital

4. Oversight

5. Study Description

Brief Summary

A clinical trial to investigate the influence of CYP2C19 polymorphism on pharmacokinetic/pharmacodynamic characteristics of omeprazole in healthy Korean volunteers

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stomach Ulcer

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CYP2C19 EM

Arm Type

Experimental

Arm Description

CYP2C19 EM

Arm Title

CYP2C19 IM

Arm Type

Experimental

Arm Description

CYP2C19 IM

Arm Title

CYP2C19 PM

Arm Type

Experimental

Arm Description

CYP2C19 PM

Intervention Type

Drug

Intervention Name(s)

Omeprazole

Primary Outcome Measure Information:

Title

mean and median Intragastric PH

Time Frame

24 hour

Secondary Outcome Measure Information:

Title

AUC

Time Frame

12 hour

Title

Cmax

Time Frame

12 hour

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Are able to provide written informed consent. The subject is a healthy Korean aged 20 to 45 years, inclusive. The subject weighs at least 55 (for female, 55) to 90 kg and has a body mass index (BMI) range of 18 to 25 kg/m2 Exclusion Criteria: Subjects with evidence or a history of clinically significant pulmonary, cardiovascular, hepatic, endocrine, hematological, neurologic or psychiatric diseases. Subjects with evidence of gastrointestinal disease which can affect the absorption of drug. Subjects with a history of drug abuse or a positive result in the urine drug screening for drug abuse Subjects who have taken any prescribed medicine or herbal medicine within 2 weeks before the first administration of the investigational product, any non-prescribed medicine or vitamin supplement within 1 week prior the first administration of the investigational product (if all other conditions are satisfied, subjects may be eligible for the trial as judged by the investigator.) Subjects who have donated a unit of whole blood within 30 days or who have participated in any other clinical trial within 60 days prior the first administration of the investigational product Subject who have history of allergy on omeprazole Subject who can not continue proper contraception method during study period. Subject with a positive urine HCG test result on screening. (in case of woman subject) Subjects who consume more than 21 units of alcohol per week (1 unit = 10 g of pure alcohol) or who are unable to abstain from drinking during the PK/PD testing period Subjects who consume more than 10 cigarette per day or who are unable to abstain from smoking during the PK/PD testing period Subjects who are unable to abstain from grapefruit or caffeine containing food 3 day prior the first administration of the investigational product Subjects judged not eligible for the study after reviewing the clinical laboratory results or other reasons by the investigator.

Facility Information:

Facility Name

Seoul National University Hospital

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

28378544

Citation

Park S, Hyun YJ, Kim YR, Lee JH, Ryu S, Kim JM, Oh WY, Na HS, Lee JG, Seo DW, Hwang IY, Park Z, Jang IJ, Oh J, Choi SE. Effects of CYP2C19 Genetic Polymorphisms on PK/PD Responses of Omeprazole in Korean Healthy Volunteers. J Korean Med Sci. 2017 May;32(5):729-736. doi: 10.3346/jkms.2017.32.5.729.

Results Reference

derived

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Influence of CYP2C19 Polymorphism on PK/PD of Omeprazole

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