Influence of CYP2C19 Polymorphism on PK/PD of Omeprazole

NCT02299687 | Completed Phase 1

• 1 other identifier: OMP_CYP2C19
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stomach Ulcer

Outcome Measures

Primary Outcomes (1)

• mean and median Intragastric PH

  24 hour

Secondary Outcomes (2)

• AUC

  12 hour

• Cmax

  12 hour

Study Arms (3)

CYP2C19 EM

EXPERIMENTAL

CYP2C19 EM

Drug: Omeprazole

CYP2C19 IM

EXPERIMENTAL

CYP2C19 IM

Drug: Omeprazole

CYP2C19 PM

EXPERIMENTAL

CYP2C19 PM

Drug: Omeprazole

Interventions

Omeprazole DRUG

CYP2C19 EM; CYP2C19 IM; CYP2C19 PM

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 28378544 DERIVED

MeSH Terms

Conditions

Stomach Ulcer

Interventions

Omeprazole

Condition Hierarchy (Ancestors)

Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of clinical pharmacology

Study Record Dates

• First Submitted: September 21, 2014
• First Posted: November 24, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2014
• Last Updated: January 1, 2015

Record last verified: 2014-12

Locations

KR (1)