Influence of CYP2C19 Polymorphism on PK/PD of Omeprazole | NCT02299687

Studies
Influence of CYP2C19 Polymorphism on PK/PD of Omeprazole

NCT02299687

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Jan 1, 2015Estimated

Enrollment

24Actual

Phase

Phase 1

Conditions

Stomach Ulcer

Interventions

Omeprazole

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2014

Primary Completion Date

Dec 2014Actual

Completion Date

Not provided

First Submitted Date

Sep 21, 2014

First Submission Date that Met QC Criteria

Nov 20, 2014

First Posted Date

Nov 24, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 31, 2014

Last Update Posted Date

Jan 1, 2015Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Label	Type	Description	Intervention Names
CYP2C19 EM	Experimental	CYP2C19 EM	Drug: Omeprazole
CYP2C19 IM	Experimental	CYP2C19 IM	Drug: Omeprazole
CYP2C19 PM	Experimental	CYP2C19 PM	Drug: Omeprazole

Name	Type	Description	Arm Group Labels	Other Names
Omeprazole	Drug		CYP2C19 EM CYP2C19 IM CYP2C19 PM

Measure	Description	Time Frame
mean and median Intragastric PH		24 hour

Measure	Description	Time Frame
AUC		12 hour
Cmax		12 hour

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28378544	Derived	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.

ID	Term
D010437	Peptic Ulcer
D004378	Duodenal Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases

ID	Term
D053799	2-Pyridinylmethylsulfinylbenzimidazoles
D013454	Sulfoxides
D013457	Sulfur Compounds
D009930	Organic Chemicals