HealthyPhase 1NCT05723510
PK and PD Interaction Between Tegoprazan and NOACs After Multiple Oral Dosing in Healthy Volunteers
A Phase 1 study testing Tegoprazan 50mg, Edoxaban 60mg and Apixaban 5mg 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 combination therapy of tegoprazan and novel oral anticoagulants (NOACs) on the pharmacokinetic and pharmacodynamic properties of NOACs in healthy adults. Read more about this study
- Who is it for?
- Ages 19 to 54 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Tegoprazan 50mg, Edoxaban 60mg and Apixaban 5mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Mar 2023to 24 Jul 2023
- 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 54 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults aged ≥ 19 years to < 55 years at the time of screening
- Those with body weight ≥ 45 kg (but ≥ 60 kg for cohort 1 and cohort 2) and body mass index (BMI) in the range of 19.0 kg/m2 to 27.0 kg/m2 at the time of screening
- ☞ BMI = weight (kg) / height (m)2
- Those who have neither congenital/chronic disease (within recent 3 years) nor pathological symptoms/findings as a result of medical examination
- Those determined to be eligible for this study based on the findings of screening such as clinical laboratory tests (hematological test, blood chemistry test, blood coagulation test, urinalysis, test for viruses/bacteria, etc.), vital signs, and electrocardiogram (ECG) which are performed by the investigator according to the properties of medicines
- Those who are fully informed of study purpose, procedures, etc., voluntarily decide to participate in this study, and sign an informed consent form (ICF) approved by the Institutional Review Board (IRB) of Jeonbuk National University Hospital, prior to participation in the study
- Those with a capability/willingness to participate throughout the study
Who cannot join
- Medical history of clinically significant blood, renal, endocrine, respiratory, gastrointestinal (peptic ulcer, etc.), urinary, cardiovascular, hepatic, psychiatric, neurological or immune disease (but except for history of simple dental treatment such as tartar, impacted teeth, and third molar teeth) or evidence thereof
- Previous history of gastrointestinal disease (except for esophageal disease such as esophageal achalasia or esophageal stricture, inflammatory bowel disease (Crohn's disease, ulcerative colitis)) or surgery (not including simple appendectomy, hernia surgery, tooth extraction, etc.) which may affect drug absorption
- Following findings of clinical laboratory tests:
- ☞ ALT or AST value > twice the upper limit of normal (ULN)
- History of periodic alcohol consumption exceeding 210 g/week within 6 months prior to screening (beer (5%) 1 glass (250 mL) = 10 g, soju (20%) 1 glass (50 mL) = 8 g, wine (12%) 1 glass (125 mL) = 12 g)
- Administration of another investigational product within 6 months prior to the first dose of the investigational product
Show all 25Show fewer
- History of serious alcohol or drug misuse and abuse within 1 year prior to screening
- Administration of drugs known to markedly induce or inhibit drug metabolizing enzymes within 30 days prior to the first dose of the investigational product
- History of smoked cigarettes ≥ 20 cigarettes/day within 6 months prior to screening
- Administration of a prescription or non-prescription drug within 10 days prior to the first dose of the investigational product
- Whole blood donation within 2 months prior to the first dose of the investigational product or apheresis donation within 1 month prior to the first dose of the investigational product
- Those who may be put at an increased risk due to the adminisration of the investigational product and study participation or have a severe acute/chronic medical or mental condition which may interfere with the interpretation of study results
- Patients with hypersensitivity to tegoprazan, edoxaban, apixaban, rivaroxaban, etc. (e.g., asthma, acute rhinitis, nasal polyp, angioedema, urticaria, allergic reactions, etc.)
- Patients with a clinically significant bleeding
- Patients with hemostatic disorder and hepatic disease related to a clinically significant risk of bleeding
- Severe hepatic impairment
- Renal impairment (eGFR <60 ml/min/1.73m2)
- Hereditary problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- Pregnant/breast-feeding women
- Those who cannot use medically acceptable contraceptive methods throughout the study
- ▶ Medically acceptable contraceptive methods
- Use of intrauterine device (IUD) showing a demonstrated pregnancy failure rate
- Combined use of barrier contraceptive method (for male or female) and spermicide
- Use of vasectomy, tubectomy/tubal ligation, or hysterectomy
- Those who are not eligible for the study in the judgment of the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, Crossover Study to Evaluate the Pharmacokinetic and Pharmacodynamic Interaction Between Tegoprazan and Novel Oral Anticoagulants (NOACs) After Multiple Oral Dosing in Healthy Volunteers
This study aims to evaluate the effects of combination therapy of tegoprazan and novel oral anticoagulants (NOACs) on the pharmacokinetic and pharmacodynamic properties of NOACs in healthy adults.
Read the detailed description
A randomized, open-label, multiple-dose, two-arm, two-period crossover study
[Cohort 1] To evaluate the effects of combination therapy of tegoprazan and edoxaban on the pharmacokinetic and pharmacodynamic properties of edoxaban in healthy adults.
[Cohort 2] To evaluate the effects of combination therapy of tegoprazan and apixaban on the pharmacokinetic and pharmacodynamic properties of apixaban in healthy adults.
[Cohort 3] To evaluate the effects of combination therapy of tegoprazan and rivaroxaban on the pharmacokinetic and pharmacodynamic properties of rivaroxaban in healthy adults.
- Conditions
- Healthy
- Being tested
- Tegoprazan 50mg, Edoxaban 60mg, Apixaban 5mg, Rivaroxaban 20mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tegoprazan 50mgDrug
Also called K-CAB Tab. 50 mg
Oral administration of one tablet of tegoprazan 50 mg once daily
Edoxaban 60mgDrug
Also called Lixiana Tab. 60mg
Oral administration of one tablet of edoxaban 60 mg once daily
Apixaban 5mgDrug
Also called Eliquis Tab. 5 mg
Oral administration of one tablet of apixaban 5 mg twice daily
Rivaroxaban 20mgDrug
Also called Xarelto Tab. 20 mg
Oral administration of one tablet of rivaroxaban 20 mg once daily
| Study group | Role | What they receive |
|---|---|---|
| Edoxaban 60mg | Experimental | Multiple dosing of edoxaban alone once daily for 5 days Receives: Drug: Edoxaban 60mg |
| Edoxaban 60mg + Tegoprazan 50mg | Experimental | Multiple dosing of edoxaban once daily in combination with tegoprazan once daily for 5 days Receives: Drug: Tegoprazan 50mg; Drug: Edoxaban 60mg |
| Apixaban 5mg | Experimental | Multiple dosing of apixaban alone twice daily for 5 days Receives: Drug: Apixaban 5mg |
| Apixaban 5mg + Tegoprazan 50mg | Experimental | Multiple dosing of apixaban twice daily in combination with tegoprazan once daily for 5 days Receives: Drug: Tegoprazan 50mg; Drug: Apixaban 5mg |
| Rivaroxaban 20mg | Experimental | Multiple dosing of rivaroxaban alone once daily for 5 days Receives: Drug: Rivaroxaban 20mg |
| Rivaroxaban 20mg + Tegoprazan 50mg | Experimental | Multiple dosing of rivaroxaban once daily in combination with tegoprazan once daily for 5 days Receives: Drug: Tegoprazan 50mg; Drug: Rivaroxaban 20mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCτ and Css,max of edoxaban
Area under the plasma concentration-time curve during a steady-state dosing interval (τ) and maximum plasma concentration at steady state of edoxaban
Measured: Pre-dose(0 hour) on 1D, 3D, and 4D for each period; pre-dose(0 hour) up to 48 hours after treatment on 5D for each period
AUCτ and Css,max of apixaban
Area under the plasma concentration-time curve during a steady-state dosing interval (τ) and maximum plasma concentration at steady state of apixaban
Measured: Pre-dose (0 hour) in the morning on 1D and in the morning and afternoon on 4D for each period; pre-dose(0 hour) in the morning up to 48 hours after treatment on 5D for each period
AUCτ and Css,max of rivaroxaban
Area under the plasma concentration-time curve during a steady-state dosing interval (τ) and maximum plasma concentration at steady state of rivaroxaban
Measured: Pre-dose (0 hour) on 1D, 3D, and 4D for each period; pre-dose(0 hour) up to 48 hours after treatment on 5D for each period
AUECτ and Emax of Anti-Factor Xa activity, PT, aPTT, and Prothrombin (INR)
Area under the effect-time curve over the dosing interval (τ) at steady state and maximum effect of Anti-Factor Xa activity, PT, aPTT, and Prothrombin (INR)
Measured: Pre-dose (0 hour) up to 24 hours after treatment on 5D for each period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start6 Mar 2023
- Primary completion17 Jul 2023
- Study completion24 Jul 2023
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
- Model description
- two-arm, two-period crossover
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Min-Gul Kim, Principal investigator, Clinical Pharmacology Center, Jeonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05723510
- Sponsor's protocol ID
- IN_APA_121
- Status last verified
- Dec 2023
- First submitted
- 2 Feb 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
- An Open-label, Randomized, Crossover Study to Evaluate the Pharmacokinetic and Pharmacodynamic Interaction Between Tegoprazan and Novel Oral Anticoagulants (NOACs) After Multiple Oral Dosing in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05723510
- Acronym / sponsor ID
- IN_APA_121
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 17 Jul 2023 (actual)
- Study completion
- 24 Jul 2023 (actual)
- First posted
- 10 Feb 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 combination therapy of tegoprazan and novel oral anticoagulants (NOACs) on the pharmacokinetic and pharmacodynamic properties of NOACs in healthy adults.
Detailed description
A randomized, open-label, multiple-dose, two-arm, two-period crossover study
[Cohort 1] To evaluate the effects of combination therapy of tegoprazan and edoxaban on the pharmacokinetic and pharmacodynamic properties of edoxaban in healthy adults.
[Cohort 2] To evaluate the effects of combination therapy of tegoprazan and apixaban on the pharmacokinetic and pharmacodynamic properties of apixaban in healthy adults.
[Cohort 3] To evaluate the effects of combination therapy of tegoprazan and rivaroxaban on the pharmacokinetic and pharmacodynamic properties of rivaroxaban in healthy adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- two-arm, two-period crossover
| Arm | Type | Receives |
|---|---|---|
| Edoxaban 60mg | Experimental | Drug: Edoxaban 60mgMultiple dosing of edoxaban alone once daily for 5 days |
| Edoxaban 60mg + Tegoprazan 50mg | Experimental | Drug: Tegoprazan 50mg, Drug: Edoxaban 60mgMultiple dosing of edoxaban once daily in combination with tegoprazan once daily for 5 days |
| Apixaban 5mg | Experimental | Drug: Apixaban 5mgMultiple dosing of apixaban alone twice daily for 5 days |
| Apixaban 5mg + Tegoprazan 50mg | Experimental | Drug: Tegoprazan 50mg, Drug: Apixaban 5mgMultiple dosing of apixaban twice daily in combination with tegoprazan once daily for 5 days |
| Rivaroxaban 20mg | Experimental | Drug: Rivaroxaban 20mgMultiple dosing of rivaroxaban alone once daily for 5 days |
| Rivaroxaban 20mg + Tegoprazan 50mg | Experimental | Drug: Tegoprazan 50mg, Drug: Rivaroxaban 20mgMultiple dosing of rivaroxaban once daily in combination with tegoprazan once daily for 5 days |
Who may qualify
- Ages
- 19 to 54 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy adults aged ≥ 19 years to < 55 years at the time of screening
- Those with body weight ≥ 45 kg (but ≥ 60 kg for cohort 1 and cohort 2) and body mass index (BMI) in the range of 19.0 kg/m2 to 27.0 kg/m2 at the time of screening
- ☞ BMI = weight (kg) / height (m)2
- Those who have neither congenital/chronic disease (within recent 3 years) nor pathological symptoms/findings as a result of medical examination
- Those determined to be eligible for this study based on the findings of screening such as clinical laboratory tests (hematological test, blood chemistry test, blood coagulation test, urinalysis, test for viruses/bacteria, etc.), vital signs, and electrocardiogram (ECG) which are performed by the investigator according to the properties of medicines
Key exclusion criteria (25 listed)
- Medical history of clinically significant blood, renal, endocrine, respiratory, gastrointestinal (peptic ulcer, etc.), urinary, cardiovascular, hepatic, psychiatric, neurological or immune disease (but except for history of simple dental treatment such as tartar, impacted teeth, and third molar teeth) or evidence thereof
- Previous history of gastrointestinal disease (except for esophageal disease such as esophageal achalasia or esophageal stricture, inflammatory bowel disease (Crohn's disease, ulcerative colitis)) or surgery (not including simple appendectomy, hernia surgery, tooth extraction, etc.) which may affect drug absorption
- Following findings of clinical laboratory tests:
- ☞ ALT or AST value > twice the upper limit of normal (ULN)
- History of periodic alcohol consumption exceeding 210 g/week within 6 months prior to screening (beer (5%) 1 glass (250 mL) = 10 g, soju (20%) 1 glass (50 mL) = 8 g, wine (12%) 1 glass (125 mL) = 12 g)
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 |
|---|---|---|
| Tegoprazan 50mgAlso: K-CAB Tab. 50 mgOral administration of one tablet of tegoprazan 50 mg once daily | Drug | Apixaban 5mg + Tegoprazan 50mg, Edoxaban 60mg + Tegoprazan 50mg, Rivaroxaban 20mg + Tegoprazan 50mg |
| Edoxaban 60mgAlso: Lixiana Tab. 60mgOral administration of one tablet of edoxaban 60 mg once daily | Drug | Edoxaban 60mg, Edoxaban 60mg + Tegoprazan 50mg |
| Apixaban 5mgAlso: Eliquis Tab. 5 mgOral administration of one tablet of apixaban 5 mg twice daily | Drug | Apixaban 5mg, Apixaban 5mg + Tegoprazan 50mg |
| Rivaroxaban 20mgAlso: Xarelto Tab. 20 mgOral administration of one tablet of rivaroxaban 20 mg once daily | Drug | Rivaroxaban 20mg, Rivaroxaban 20mg + Tegoprazan 50mg |
Primary outcome
AUCτ and Css,max of edoxaban
Time frame: Pre-dose(0 hour) on 1D, 3D, and 4D for each period; pre-dose(0 hour) up to 48 hours after treatment on 5D for each period
Area under the plasma concentration-time curve during a steady-state dosing interval (τ) and maximum plasma concentration at steady state of edoxaban
AUCτ and Css,max of apixaban
Time frame: Pre-dose (0 hour) in the morning on 1D and in the morning and afternoon on 4D for each period; pre-dose(0 hour) in the morning up to 48 hours after treatment on 5D for each period
Area under the plasma concentration-time curve during a steady-state dosing interval (τ) and maximum plasma concentration at steady state of apixaban
AUCτ and Css,max of rivaroxaban
Time frame: Pre-dose (0 hour) on 1D, 3D, and 4D for each period; pre-dose(0 hour) up to 48 hours after treatment on 5D for each period
Area under the plasma concentration-time curve during a steady-state dosing interval (τ) and maximum plasma concentration at steady state of rivaroxaban
AUECτ and Emax of Anti-Factor Xa activity, PT, aPTT, and Prothrombin (INR)
Time frame: Pre-dose (0 hour) up to 24 hours after treatment on 5D for each period
Area under the effect-time curve over the dosing interval (τ) at steady state and maximum effect of Anti-Factor Xa activity, PT, aPTT, and Prothrombin (INR)
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 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.
Min-Gul Kim principal investigator
Clinical Pharmacology Center, Jeonbuk National University Hospital
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 Tegoprazan 50mg, Edoxaban 60mg and Apixaban 5mg 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 7 inclusion and 25 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 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?
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?
AUCτ and Css,max of edoxaban (time frame: Pre-dose(0 hour) on 1D, 3D, and 4D for each period; pre-dose(0 hour) up to 48 hours after treatment on 5D for each period). The study lists 4 primary outcomes in all. 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.