HealthyPhase 1NCT06164834
Effect of Tegoprazan on Pharmacodynamics of Clopidogrel in Healthy Subjects
A Phase 1 study testing Clopidogrel 75 mg, Tegoprazan 25 mg and Esomeprazole 20mg in people with Healthy, run by HK inno.N Corporation at 1 site in South Korea.
Trial summary
This study aims to evaluate the effects of tegoprazan or esomeprazole administered in combination with clopidogrel on the pharmacodynamics/Pharmacokinetics of clopidogrel in healthy adults Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Clopidogrel 75 mg, Tegoprazan 25 mg and Esomeprazole 20mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Dec 2023to Nov 2024
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults 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
- Is given a detailed explanation and fully understood the study, then voluntarily decided to participate and provided written informed consent before any screening procedure
- Negative for serum Helicobacter pylori antibodies
- Judged by the investigator to be eligible for this study based on physical examination, laboratory test, inquiry, etc.
Who cannot join
- Presence or history of clinically significant liver, kidney, nervous system, respiratory system, endocrine system, blood and tumor, cardiovascular system, urinary system or psychiatric disease
- Presence or history of gastrointestinal disorder (gastrointestinal ulcer, gastritis, gastrospasm, gastroesophageal reflux disease, Crohn's disease, etc.) that may influence the safety and pharmacodynamic assessments of the investigational product and history of gastrointestinal surgery (except simple appendectomy and hernia surgery), hemostatic disorder or hemorrhage-related disease
- Hypersensitivity to drugs including the ingredients of the investigational product and other drugs (aspirin, antibiotics, etc.) or history of clinically significant hypersensitivity
- Positive result in serology tests (Hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) test, syphilis test)
- Blood total bilirubin, AST (GOT), and ALT (GPT) > 1.5 x upper limit of normal range at the screening test
- Platelet, PT and aPTT levels outside the upper/lower limit of normal range by 10% at the screening test
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- Systolic blood pressure is < 90 mmHg or > 139 mmHg, diastolic blood pressure < 50 mmHg or > 89 mmHg, or pulse rate is < 45 beats/minute or > 100 beats/minute when vital signs are measured in sitting position after resting for at least 3 minutes at the screening test
- Showing the following findings on ECG at the screening test: QTc > 450 msec, PR interval > 210 msec, QRS interval > 120 msec, Other clinically significant findings
- P2Y12 Reaction Unit (PRU) outside the upper/lower limit of normal range by 10% as a result of P2Y12 assay at the screening test
- History of drug abuse or positive urine screening for drug abuse
- 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
Seung Hwan Lee, MD, PhD, 82-2-2072-2343, leejh413@snu.ac.kr
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 in Healthy Subjects
This study aims to evaluate the effects of tegoprazan or esomeprazole administered in combination with clopidogrel on the pharmacodynamics/Pharmacokinetics of clopidogrel in healthy adults
Read the detailed description
Evaluation Criteria:
- Primary outcome Pharmacodynamic assessments using P2Y12 assay
- Secondary outcome Pharmacokinetics assessments on Cmax,ss, Cmin,ss, Cavg,ss, AUCτ,ss, Tmax,ss, t1/2,ss, CLss/F, Vd,ss/F, and PTF of clopidogrel
- 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 25 mg, Esomeprazole 20mg
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 25 mgDrug
Also called K-CAB
Tegoprazan 25 mg tablet
Esomeprazole 20mgDrug
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 25 mg | Experimental | Oral administration of clopidogrel 75 mg tablet and tegoprazan 25 mg tablet once daily for 7 days Receives: Drug: Clopidogrel 75 mg; Drug: Tegoprazan 25 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 20mg |
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, 7 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 posted11 Dec 2023
- Study start5 Dec 2023 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionNov 2024 (estimated)
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
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Seung Hwan Lee, Principal investigator, Seoul National University Hospital, Dept. of Clinical Pharmacology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06164834
- Sponsor's protocol ID
- IN_APA_123
- Status last verified
- Dec 2023
- First submitted
- 1 Dec 2023
- Last updated
- 11 Dec 2023
- 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 11 Dec 2023. 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 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06164834
- Acronym / sponsor ID
- IN_APA_123
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- 5 Dec 2023 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 11 Dec 2023 (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 effects of tegoprazan or esomeprazole administered in combination with clopidogrel on the pharmacodynamics/Pharmacokinetics of clopidogrel in healthy adults
Detailed description
Evaluation Criteria:
- Primary outcome Pharmacodynamic assessments using P2Y12 assay
- Secondary outcome Pharmacokinetics assessments on Cmax,ss, Cmin,ss, Cavg,ss, AUCτ,ss, Tmax,ss, t1/2,ss, CLss/F, Vd,ss/F, and PTF of clopidogrel
- 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 25 mg | Experimental | Drug: Clopidogrel 75 mg, Drug: Tegoprazan 25 mgOral administration of clopidogrel 75 mg tablet and tegoprazan 25 mg tablet once daily for 7 days |
| Clopidogrel 75 mg + Esomeprazole 20 mg | Experimental | Drug: Clopidogrel 75 mg, Drug: Esomeprazole 20mgOral 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
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy adults 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
- Is given a detailed explanation and fully understood the study, then voluntarily decided to participate and provided written informed consent before any screening procedure
- Negative for serum Helicobacter pylori antibodies
- Judged by the investigator to be eligible for this study based on physical examination, laboratory test, inquiry, etc.
Key exclusion criteria (11 listed)
- Presence or history of clinically significant liver, kidney, nervous system, respiratory system, endocrine system, blood and tumor, cardiovascular system, urinary system or psychiatric disease
- Presence or history of gastrointestinal disorder (gastrointestinal ulcer, gastritis, gastrospasm, gastroesophageal reflux disease, Crohn's disease, etc.) that may influence the safety and pharmacodynamic assessments of the investigational product and history of gastrointestinal surgery (except simple appendectomy and hernia surgery), hemostatic disorder or hemorrhage-related disease
- Hypersensitivity to drugs including the ingredients of the investigational product and other drugs (aspirin, antibiotics, etc.) or history of clinically significant hypersensitivity
- Positive result in serology tests (Hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) test, syphilis test)
- Blood total bilirubin, AST (GOT), and ALT (GPT) > 1.5 x upper limit of normal range at the screening test
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 25 mg |
| Tegoprazan 25 mgAlso: K-CABTegoprazan 25 mg tablet | Drug | Clopidogrel 75 mg + Tegoprazan 25 mg |
| Esomeprazole 20mgAlso: 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, 7 and 8 in each period
Pharmacodynamic blood sampling to measure PRU using VerifyNow® system
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
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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.
Seung Hwan Lee 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 25 mg and Esomeprazole 20mg 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 11 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: status not confirmed, as of the sponsor's last update on 11 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eun Ji Kim (82-2-6477-0290, eunji.kim24@inno-n.com), or a site near the patient. 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, 7 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 11 Dec 2023.