HealthyPhase 1NCT03814642
Effect of Tegoprazan on Pharmacodynamics of Clopidogrel in Healthy Male Participants
A Phase 1 study testing Clopidogrel 75 mg, Tegoprazan 50 mg and Esomeprazole 20 mg in people with Healthy, run by HK inno.N Corporation at 1 site in South Korea.
Trial summary
This study aims to evaluate the influence of tegoprazan on the pharmacodynamics of clopidogrel according to CYP2C19 genotypes following co-administration of tegoprazan and clopidogrel in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 19 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Clopidogrel 75 mg, Tegoprazan 50 mg and Esomeprazole 20 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Jan 2019to 22 Jul 2019
- 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 19 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult males aged ≥ 19 years and ≤ 50 years on the date of the written informed consent
- Body weight of ≥ 55.0 kg and ≤ 90.0 kg, with body mass index (BMI) of ≥ 18.0 kg/m2 and ≤ 27.0 kg/m2 at the time of screening
- Helicobacter pylori negative
- Voluntarily decided to participate in the study and provided written informed consent before any screening procedure
- Judged by the investigator to be eligible for this study based on physical examination, laboratory test, inquiry, etc.
Who cannot join
- Has a history of or currently has clinically significant liver, kidney, nervous system, respiratory system, endocrine system, blood, cardiovascular system, urinary system, or psychiatric disease or tumor
- Has a history of or currently has gastrointestinal disorder (gastrointestinal ulcer, gastritis, stomach cramps, gastroesophageal reflux disease, Crohn's disease, etc.) that may influence the safety and pharmacodynamic assessments of the investigational product
- Has a history of gastrointestinal surgery (except simple appendectomy and hernia surgery)
- Hypersensitivity to drugs including the ingredients of the investigational product and other drugs (aspirin, antibiotics, etc.) or a history of clinically significant hypersensitivity
- Positive serological test including hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
- Blood total bilirubin, AST (GOT), and ALT (GPT) levels greater than 1.5x of the upper limit of normal range at screening
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- Platelet, PT and aPTT levels outside the upper/lower limit of normal range by 10% at screening
- P2Y12 Reaction Unit (PRU) by P2Y12 assay outside the upper/lower limit of normal range by 10% at screening
- *17 allele by CYP2C19 genotyping (Ultrarapid metabolizer)
- Systolic blood pressure < 90 mmHg or > 140 mmHg, diastolic blood pressure < 50 mmHg or > 95 mmHg, or pulse rate < 45 beats/minute or > 100 beats/minute when vital signs are measured in sitting position after resting for at least 5 minutes during screening
- QTc > 450 msec, PR interval > 200 msec, QRS interval > 120 msec, and other clinically significant findings on electrocardiogram at screening
- Has a history of or positive urine screening for drug abuse
- Administration of any prescription drugs or herbal medicine within 2 weeks prior to the expected date of the first dose, or administration of any over-the-counter (OTC) drug, health functional food or vitamin within 1 week prior to the expected date of the first dose (However, can participate in the study if otherwise decided eligible by the investigator)
- Participation in other clinical study or bioequivalence study to receive an investigational product within 3 months prior to the expected date of the first dose
- Donation of whole blood within 2 months or apheresis/receipt of blood transfusion within 1 month prior to the expected date of the first dose
- Excessive caffeine intake (> 5 units/day) or persistent alcohol intake (> 21 units/week, 1 unit = 10 g of pure alcohol), or inability to abstain from drinking during hospitalization period
- Smoking for more than 3 months prior to the study or inability to cease smoking throughout the study
- Inability to refrain from grapefruit-containing food from 24 hours before admission to discharge
- Inability to refrain from caffeine-containing food (coffee, tea (black tea, green tea, etc.), carbonated drink, coffee-flavored milk, nutritional tonic, etc.) from 24 hours before admission to discharge
- Inability to use a medically acceptable method of contraception throughout the study. Medically acceptable methods of contraception include use of intrauterine device with established failure rate of contraception by spouse (or partner), concomitant use of barrier method (for male or for female) and spermicide, or surgical procedure on subject himself or his partner (vasectomy, tubal resection/ligation, hysterectomy)
- Considered ineligible to participate in the study by the investigator based on laboratory test results or other reasons
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital, Clinical Trial Center
Seoul
About this study
Official title: A Randomized, Open-label, Three-period, Multiple Dosing Crossover Clinical Trial to Evaluate the Influence of Tegoprazan on the Pharmacodynamics of Clopidogrel According to CYP2C19 Genotypes in Healthy Male Volunteers
This study aims to evaluate the influence of tegoprazan on the pharmacodynamics of clopidogrel according to CYP2C19 genotypes following co-administration of tegoprazan and clopidogrel in healthy male volunteers.
Read the detailed description
Evaluation Criteria:
- Pharmacodynamic assessments using P2Y12 assay
- Safety assessments with adverse event monitoring including subjective/objective symptoms, physical examination, vital signs, electrocardiogram, and laboratory test
- Conditions
- Healthy
- Being tested
- Clopidogrel 75 mg, Tegoprazan 50 mg, Esomeprazole 20 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clopidogrel 75 mgDrug
Also called Plavix
Clopidogrel 75 mg tablet
Tegoprazan 50 mgDrug
Also called K-CAB
Tegoprazan 50 mg tablet
Esomeprazole 20 mgDrug
Also called Nexium
Esomeprazole 20 mg tablet
| Study group | Role | What they receive |
|---|---|---|
| Clopidogrel 75 mg | Active comparator | Oral administration of clopidogrel 75 mg tablet once daily for 7 days Receives: Drug: Clopidogrel 75 mg |
| Clopidogrel 75 mg + Tegoprazan 50 mg | Experimental | Oral administration of clopidogrel 75 mg tablet and tegoprazan 50 mg tablet once daily for 7 days Receives: Drug: Clopidogrel 75 mg; Drug: Tegoprazan 50 mg |
| Clopidogrel 75 mg + Esomeprazole 20 mg | Experimental | Oral administration of clopidogrel 75 mg tablet and esomeprazole 20 mg tablet once daily for 7 days Receives: Drug: Clopidogrel 75 mg; Drug: Esomeprazole 20 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in P2Y12 Reaction Unit (PRU) from baseline
Pharmacodynamic blood sampling to measure PRU using VerifyNow® system
Measured: Pre-dose(0h) on days 1, 3, 5, and 8 in each period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start21 Jan 2019
- Primary completion22 Jul 2019
- Study completion22 Jul 2019
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.
- More trials run by HK inno.N CorporationThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- In-Jin Jang, Principal investigator, Seoul National University Hospital, Dept. of Clinical Pharmacology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03814642
- Sponsor's protocol ID
- CJ_APA_110
- Status last verified
- Oct 2019
- First submitted
- 20 Jan 2019
- Last updated
- 21 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Three-period, Multiple Dosing Crossover Clinical Trial to Evaluate the Influence of Tegoprazan on the Pharmacodynamics of Clopidogrel According to CYP2C19 Genotypes in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT03814642
- Acronym / sponsor ID
- CJ_APA_110
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- 21 Jan 2019 (actual)
- Primary completion
- 22 Jul 2019 (actual)
- Study completion
- 22 Jul 2019 (actual)
- First posted
- 24 Jan 2019 (actual)
- 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.
This study aims to evaluate the influence of tegoprazan on the pharmacodynamics of clopidogrel according to CYP2C19 genotypes following co-administration of tegoprazan and clopidogrel in healthy male volunteers.
Detailed description
Evaluation Criteria:
- Pharmacodynamic assessments using P2Y12 assay
- Safety assessments with adverse event monitoring including subjective/objective symptoms, physical examination, vital signs, electrocardiogram, and laboratory test
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clopidogrel 75 mg | Active comparator | Drug: Clopidogrel 75 mgOral administration of clopidogrel 75 mg tablet once daily for 7 days |
| Clopidogrel 75 mg + Tegoprazan 50 mg | Experimental | Drug: Clopidogrel 75 mg, Drug: Tegoprazan 50 mgOral administration of clopidogrel 75 mg tablet and tegoprazan 50 mg tablet once daily for 7 days |
| Clopidogrel 75 mg + Esomeprazole 20 mg | Experimental | Drug: Clopidogrel 75 mg, Drug: Esomeprazole 20 mgOral administration of clopidogrel 75 mg tablet and esomeprazole 20 mg tablet once daily for 7 days |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy adult males aged ≥ 19 years and ≤ 50 years on the date of the written informed consent
- Body weight of ≥ 55.0 kg and ≤ 90.0 kg, with body mass index (BMI) of ≥ 18.0 kg/m2 and ≤ 27.0 kg/m2 at the time of screening
- Helicobacter pylori negative
- Voluntarily decided to participate in the study and provided written informed consent before any screening procedure
- Judged by the investigator to be eligible for this study based on physical examination, laboratory test, inquiry, etc.
Key exclusion criteria (21 listed)
- Has a history of or currently has clinically significant liver, kidney, nervous system, respiratory system, endocrine system, blood, cardiovascular system, urinary system, or psychiatric disease or tumor
- Has a history of or currently has gastrointestinal disorder (gastrointestinal ulcer, gastritis, stomach cramps, gastroesophageal reflux disease, Crohn's disease, etc.) that may influence the safety and pharmacodynamic assessments of the investigational product
- Has a history of gastrointestinal surgery (except simple appendectomy and hernia surgery)
- Hypersensitivity to drugs including the ingredients of the investigational product and other drugs (aspirin, antibiotics, etc.) or a history of clinically significant hypersensitivity
- Positive serological test including hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
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 |
|---|---|---|
| Clopidogrel 75 mgAlso: PlavixClopidogrel 75 mg tablet | Drug | Clopidogrel 75 mg, Clopidogrel 75 mg + Esomeprazole 20 mg, Clopidogrel 75 mg + Tegoprazan 50 mg |
| Tegoprazan 50 mgAlso: K-CABTegoprazan 50 mg tablet | Drug | Clopidogrel 75 mg + Tegoprazan 50 mg |
| Esomeprazole 20 mgAlso: NexiumEsomeprazole 20 mg tablet | Drug | Clopidogrel 75 mg + Esomeprazole 20 mg |
Primary outcome
Change in P2Y12 Reaction Unit (PRU) from baseline
Time frame: Pre-dose(0h) on days 1, 3, 5, and 8 in each period
Pharmacodynamic blood sampling to measure PRU using VerifyNow® system
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 21 Oct 2019.
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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.
In-Jin Jang principal investigator
Seoul National University Hospital, Dept. of Clinical Pharmacology
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 Clopidogrel 75 mg, Tegoprazan 50 mg and Esomeprazole 20 mg in people with Healthy, run by HK inno.N Corporation 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 5 inclusion and 21 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 21 Oct 2019. 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?
Change in P2Y12 Reaction Unit (PRU) from baseline (time frame: Pre-dose(0h) on days 1, 3, 5, and 8 in each period). 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 21 Oct 2019.