HealthyPhase 1NCT01688544
Pharmacokinetic/Pharmacodynamic Study of Ilaprazole to Evaluate the Effect of CYP Genetic Polymorphism
A Phase 1 study testing Ilaprazole in people with Healthy, run by Inje University at 1 site in South Korea.
Trial summary
Ilaprazole is a novel proton pump inhibitor and metabolized by CYP3A4 and 2C19. Thus genetic polymorphisms of CYP3A4 and 2C19 may have effect on the pharmacokinetics and pharmacodynamics of Ilaprazole. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ilaprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2009to Dec 2011
- 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
- healthy adult volunteer between 20 and 45 years of age and within 20% of ideal body weight
- No congenital or acquired chronic disease
- appropriate for the study judging from examinations (hematology, chemistry, urinalysis and so on), vital sign and ECG results
- sign the informed consent form prior to study participation
Who cannot join
- received any metabolizing enzymes or transporters inducing or inhibiting drugs like barbiturates within 1 month prior to the date of first drug administration
- history of hypersensitivity against drugs or clinically significant allergic diseases
- abnormal laboratory results
- positive result for helicobacter pylori infection from the Urea Breath Test
- alcohol or drug abuser
- pregnant or lactating
- donated whole blood within 60days prior to the study
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Inje University Busan Paik Hoapital Clinical Trial Center
Busan, Busan, 614-735
About this study
Official title: Phase 1 Study to Evaluate the Effect of CYP Polymorphism and Gender on the Pharmacokinetics and Pharmacodynamics of Ilaprazole After Multiple Dosing
Ilaprazole is a novel proton pump inhibitor and metabolized by CYP3A4 and 2C19. Thus genetic polymorphisms of CYP3A4 and 2C19 may have effect on the pharmacokinetics and pharmacodynamics of Ilaprazole.
Read the detailed description
Effects of genetic polymorphisms on the pharmacokinetics or pharmacodynamics were measured in healthy Korean volunteers
- Conditions
- Healthy
- Being tested
- Ilaprazole
- Keywords
- Ilaprazole, Intragastric pH, Serum Gastrin, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IlaprazoleDrug
Also called 2-[(4methoxy-3-methyl)-2-pyridinyl] methylsulfinyl-, 5-(1H-pyrrol-1yl)-1H-benzimidazole
Ilaprazole 10 mg for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Ilaprazole | Experimental | Before Ilaprazole dosing, 24 hours intragastric pH monitoring is performed as baseline value.
After 7 days dosing of Ilaprazole 10 mg, 24 hours intragastric pH monitoring, serum gastrin level check, and pharmacokinetic sampling is performed Receives: Drug: Ilaprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 hour intragastric ph
Measured: After 7 days dosing of Ilaprazole 10 mg
Secondary outcomes (2)
Pharmacokinetic parameters (Cmax, AUC) of Ilaprazole and its metabolite
Measured: After 7 days dosing of Ilaprazole
Serum Gastrin level
Measured: After 7 days dosing of Ilaprazole
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2012 (estimated)
- Study startJan 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae-Gook Shin, Inje University
- Investigators
- JaeGook Shin, MD,PhD, Principal investigator, Inje University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01688544
- Sponsor's protocol ID
- 08-112
- Status last verified
- Sep 2012
- First submitted
- 6 Dec 2011
- Last updated
- 20 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study to Evaluate the Effect of CYP Polymorphism and Gender on the Pharmacokinetics and Pharmacodynamics of Ilaprazole After Multiple Dosing
- ClinicalTrials.gov ID
- NCT01688544
- Acronym / sponsor ID
- 08-112
- Conditions
- Healthy
- Keywords
- Ilaprazole, Intragastric pH, Serum Gastrin, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 20 Sep 2012 (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.
Ilaprazole is a novel proton pump inhibitor and metabolized by CYP3A4 and 2C19. Thus genetic polymorphisms of CYP3A4 and 2C19 may have effect on the pharmacokinetics and pharmacodynamics of Ilaprazole.
Detailed description
Effects of genetic polymorphisms on the pharmacokinetics or pharmacodynamics were measured in healthy Korean volunteers
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ilaprazole | Experimental | Drug: IlaprazoleBefore Ilaprazole dosing, 24 hours intragastric pH monitoring is performed as baseline value. After 7 days dosing of Ilaprazole 10 mg, 24 hours intragastric pH monitoring, serum gastrin level check, and pharmacokinetic sampling is performed |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- healthy adult volunteer between 20 and 45 years of age and within 20% of ideal body weight
- No congenital or acquired chronic disease
- appropriate for the study judging from examinations (hematology, chemistry, urinalysis and so on), vital sign and ECG results
- sign the informed consent form prior to study participation
Key exclusion criteria (7 listed)
- received any metabolizing enzymes or transporters inducing or inhibiting drugs like barbiturates within 1 month prior to the date of first drug administration
- history of hypersensitivity against drugs or clinically significant allergic diseases
- abnormal laboratory results
- positive result for helicobacter pylori infection from the Urea Breath Test
- alcohol or drug abuser
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 |
|---|---|---|
| IlaprazoleAlso: 2-[(4methoxy-3-methyl)-2-pyridinyl] methylsulfinyl-, 5-(1H-pyrrol-1yl)-1H-benzimidazoleIlaprazole 10 mg for 7 days | Drug | Ilaprazole |
Primary outcome
24 hour intragastric ph
Time frame: After 7 days dosing of Ilaprazole 10 mg
2 secondary outcomes
Pharmacokinetic parameters (Cmax, AUC) of Ilaprazole and its metabolite
Time frame: After 7 days dosing of Ilaprazole
Serum Gastrin level
Time frame: After 7 days dosing of Ilaprazole
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 20 Sep 2012.
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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.
JaeGook Shin, MD,PhD principal investigator
Inje University
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 Ilaprazole in people with Healthy, run by Inje University 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 4 inclusion and 7 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 20 Sep 2012. 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?
24 hour intragastric ph (time frame: After 7 days dosing of Ilaprazole 10 mg). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Sep 2012.