HealthyPhase 1NCT04171687
Effect of Tegoprazan or RAPA113 on Pharmacodynamics/Pharmacokinetics of Clopidogrel in Healthy Male Volunteers
A Phase 1 study testing Clopidogrel 75mg, Tegoprazan 50 mg and RAPA113 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 or RAPA113 on the pharmacodynamics/Pharmacokinetics of following co-administration of tegoprazan or RAPA113 and clopidogrel in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Clopidogrel 75mg, Tegoprazan 50 mg and RAPA113
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Oct 2019to 9 Apr 2020
- 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 55 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 ≥ 18.5 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
Who cannot join
- Has a history of or currently has clinically significant liver, kidney, nervous system, immune system, respiratory system, endocrine system, blood, tumor, cardiovascular system or psychiatric disease
- Has a history of gastrointestinal diseases (such as Crohn's disease, ulcer, etc.) or surgery (except for simple appendectomy or hernia) that can affect the absorption of drugs
- Has a genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- Has a clinically significant history of hemorrhage (e.g. Gastric ulcers, intracranial bleeding, haemophilia, gastrointestinal bleeding, urinary tract bleeding, vitreous hemorrhage, etc.)
- P2Y12 Reaction Unit (PRU) by P2Y12 assay outside the upper/lower limit of normal range by 10% at screening
- Considered ineligible to participate in the study based on screening test(by asking condition, vital sign, 12-lead ECG, physical exam, laboratory test etc.) results :
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- Platelet, PT and aPTT levels outside the upper/lower limit of normal range by 10%
- AST (GOT), and ALT (GPT) levels greater than 1.25x of the upper limit of normal range
- Blood total bilirubin levels greater than 1.5x of the upper limit of normal range
- Hemoglobin levels less than 12.0 g/dL
- eGFR (estimated Glomerular Filtration Rate) using MDRD (Modification of Diet in Renal Disaster) < 60 mL/min/1.73 m2
- : eGFR (estimated glomerular filtration rate) (mL/min/1.73m2) = 175 x [serum creatinine (mg/dL)]-1.154 x [age]-0.203
- positive as a result of serum examination (B-type hepatitis test, hepatitis C test, human immunodeficiency virus test, syphilis test)
- Systolic blood pressure < 90 mmHg or > 150 mmHg, diastolic blood pressure < 50 mmHg or > 100 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Multiple-dose, Crossover Clinical Trial to Explore the Drug Interaction of Tegoprazan or RAPA113 and Clopidogrel After Oral Administration in Healthy Male Volunteers
This study aims to evaluate the influence of tegoprazan or RAPA113 on the pharmacodynamics/Pharmacokinetics of following co-administration of tegoprazan or RAPA113 and clopidogrel in healthy male volunteers.
Read the detailed description
Evaluation Criteria:
- Primary outcome Pharmacodynamic assessments using P2Y12 assay
- Secondary outcome Pharmacokinetics assessments on Cmax,ss, AUCτ,ss, tmax,ss, Cmin,ss , CLss/F 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 75mg, Tegoprazan 50 mg, RAPA113
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clopidogrel 75mgDrug
Also called Plavix
Clopidogrel 75 mg tablet
Tegoprazan 50 mgDrug
Also called K-CAB
Tegoprazan 50 mg tablet
RAPA113Drug
RAPA113 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 75mg |
| Clopidogrel 75 mg + Tegoprazan 50 mg | Experimental | Oral administration of clopidogrel 75 mg tablet and Tegoprazan 50mg tablet once daily for 7 days Receives: Drug: Clopidogrel 75mg; Drug: Tegoprazan 50 mg |
| Clopidogrel 75 mg + RAPA113 | Experimental | Oral administration of clopidogrel 75 mg tablet and RAPA113 tablet once daily for 7 days Receives: Drug: Clopidogrel 75mg; Drug: RAPA113 |
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
Pharmacodynamics 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 posted21 Nov 2019
- Study start21 Oct 2019
- Primary completion7 Feb 2020
- Study completion9 Apr 2020
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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Min Soo Park, Principal investigator, Severance Hospital, Dept of Clinical Pharmacology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04171687
- Sponsor's protocol ID
- CJ_APA_113
- Status last verified
- May 2020
- First submitted
- 19 Nov 2019
- Last updated
- 8 May 2020
- 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 8 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multiple-dose, Crossover Clinical Trial to Explore the Drug Interaction of Tegoprazan or RAPA113 and Clopidogrel After Oral Administration in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT04171687
- Acronym / sponsor ID
- CJ_APA_113
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- 21 Oct 2019 (actual)
- Primary completion
- 7 Feb 2020 (actual)
- Study completion
- 9 Apr 2020 (actual)
- First posted
- 21 Nov 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 or RAPA113 on the pharmacodynamics/Pharmacokinetics of following co-administration of tegoprazan or RAPA113 and clopidogrel in healthy male volunteers.
Detailed description
Evaluation Criteria:
- Primary outcome Pharmacodynamic assessments using P2Y12 assay
- Secondary outcome Pharmacokinetics assessments on Cmax,ss, AUCτ,ss, tmax,ss, Cmin,ss , CLss/F 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 75mgOral administration of clopidogrel 75 mg tablet once daily for 7 days |
| Clopidogrel 75 mg + Tegoprazan 50 mg | Experimental | Drug: Clopidogrel 75mg, Drug: Tegoprazan 50 mgOral administration of clopidogrel 75 mg tablet and Tegoprazan 50mg tablet once daily for 7 days |
| Clopidogrel 75 mg + RAPA113 | Experimental | Drug: Clopidogrel 75mg, Drug: RAPA113Oral administration of clopidogrel 75 mg tablet and RAPA113 tablet once daily for 7 days |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 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 ≥ 18.5 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
Key exclusion criteria (14 listed)
- Has a history of or currently has clinically significant liver, kidney, nervous system, immune system, respiratory system, endocrine system, blood, tumor, cardiovascular system or psychiatric disease
- Has a history of gastrointestinal diseases (such as Crohn's disease, ulcer, etc.) or surgery (except for simple appendectomy or hernia) that can affect the absorption of drugs
- Has a genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- Has a clinically significant history of hemorrhage (e.g. Gastric ulcers, intracranial bleeding, haemophilia, gastrointestinal bleeding, urinary tract bleeding, vitreous hemorrhage, etc.)
- P2Y12 Reaction Unit (PRU) by P2Y12 assay outside the upper/lower limit of normal range by 10% at screening
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 75mgAlso: PlavixClopidogrel 75 mg tablet | Drug | Clopidogrel 75 mg, Clopidogrel 75 mg + RAPA113, Clopidogrel 75 mg + Tegoprazan 50 mg |
| Tegoprazan 50 mgAlso: K-CABTegoprazan 50 mg tablet | Drug | Clopidogrel 75 mg + Tegoprazan 50 mg |
| RAPA113RAPA113 tablet | Drug | Clopidogrel 75 mg + RAPA113 |
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
Pharmacodynamics 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 8 May 2020.
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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.
Min Soo Park principal investigator
Severance 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 75mg, Tegoprazan 50 mg and RAPA113 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 4 inclusion and 14 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 8 May 2020. 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, 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 8 May 2020.