Stomach UlcerPhase 1NCT02299687
Influence of CYP2C19 Polymorphism on PK/PD of Omeprazole
A Phase 1 study testing Omeprazole in people with Stomach Ulcer, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
A clinical trial to investigate the influence of CYP2C19 polymorphism on pharmacokinetic/pharmacodynamic characteristics of omeprazole in healthy Korean volunteers Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Stomach Ulcer
- What is being tested?
- Omeprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2014to Dec 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Trial to Investigate the Influence of CYP2C19 Polymorphism on Pharmacokinetic/Pharmacodynamic Characteristics of Omeprazole in Healthy Korean Volunteers
A clinical trial to investigate the influence of CYP2C19 polymorphism on pharmacokinetic/pharmacodynamic characteristics of omeprazole in healthy Korean volunteers
- Conditions
- Stomach Ulcer
- Being tested
- Omeprazole
- Medical subject headings
- Stomach Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmeprazoleDrug
| Study group | Role | What they receive |
|---|---|---|
| CYP2C19 EM | Experimental | CYP2C19 EM Receives: Drug: Omeprazole |
| CYP2C19 IM | Experimental | CYP2C19 IM Receives: Drug: Omeprazole |
| CYP2C19 PM | Experimental | CYP2C19 PM Receives: Drug: Omeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean and median Intragastric PH
Measured: 24 hour
Secondary outcomes (2)
AUC
Measured: 12 hour
Cmax
Measured: 12 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stomach UlcerStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In-Jin Jang, MD, PhD, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02299687
- Sponsor's protocol ID
- OMP_CYP2C19
- Status last verified
- Dec 2014
- First submitted
- 21 Sep 2014
- Last updated
- 1 Jan 2015
- Results posted
- No
Publications
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.
PubMed 28378544
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Investigate the Influence of CYP2C19 Polymorphism on Pharmacokinetic/Pharmacodynamic Characteristics of Omeprazole in Healthy Korean Volunteers
- ClinicalTrials.gov ID
- NCT02299687
- Acronym / sponsor ID
- OMP_CYP2C19
- Conditions
- Stomach Ulcer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Dec 2014 (actual)
- First posted
- 24 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A clinical trial to investigate the influence of CYP2C19 polymorphism on pharmacokinetic/pharmacodynamic characteristics of omeprazole in healthy Korean volunteers
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CYP2C19 EM | Experimental | Drug: OmeprazoleCYP2C19 EM |
| CYP2C19 IM | Experimental | Drug: OmeprazoleCYP2C19 IM |
| CYP2C19 PM | Experimental | Drug: OmeprazoleCYP2C19 PM |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omeprazole | Drug | CYP2C19 EM, CYP2C19 IM, CYP2C19 PM |
Primary outcome
mean and median Intragastric PH
Time frame: 24 hour
2 secondary outcomes
AUC
Time frame: 12 hour
Cmax
Time frame: 12 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2015.
- Derived from this study: PubMed 28378544Park 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Omeprazole in people with Stomach Ulcer, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean and median Intragastric PH (time frame: 24 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02299687, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2015; AzTrials last refreshed its copy on 7 Nov 2026.