HealthyPhase 1NCT04231136
Study to Evaluate the Pharmacodynamics After Single Oral Dosing of Tegoprazan, EAPA115 and RAPA115 in Healthy Volunteers
A Phase 1 study testing Tegoprazan 50 mg, EAPA115 and RAPA115 in people with Healthy, run by HK inno.N Corporation at 1 site in South Korea.
Trial summary
This study aims to evaluate the pharmacodynamics after single oral dosing of tegoprazan, EAPA115 and RAPA115 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 19 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Tegoprazan 50 mg, EAPA115 and RAPA115
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Jan 2020to 3 Aug 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults aged 19 to 65 years (not inclusive) at the time of signing the informed consent form (ICF).
- Body mass index (BMI) ≥ 17.5 and < 30.5 kg/m^2 with a body weight ≥ 45 kg at screening. Body mass index (kg/m^2) = weight (kg)/height (m)^2
- Confirmed as H. pylori negative
- A subject without any congenital or chronic disease within 3 years, and has no medical examination result as pathological symptoms or signs.
- A subject determined eligible for this study based on the screening test such as clinical laboratory tests (hematology test, chemistry test, urine test, virus/bacteria test, etc.), vital signs, and electrocardiogram.
- A subject who is fully informed of the purpose and content of the study and agrees to participate in the study on its own will and signs the consent form approved by the Institutional Review Board (IRB) of the Seoul National University Hospital, prior to participate in the study.
- A subject who has the ability and willingness to participate throughout the whole study period.
Who cannot join
- A subject with clinically significant blood, renal, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, hepatic, psychical, neurologic, or immunologic diseases (except for simple dental past history such as tartar, impacted tooth, or wisdom tooth) or evidence.
- A subject with a history of gastrointestinal disorders (esophageal diseases such as esophageal achalasia or esophageal stricture, Crohn's disease) or surgery (except for simple appendectomy, herniotomy, and tooth extraction surgery) that may affect the absorption of drugs.
- A subject with the *17 allele of CYP2C19 (Ultrarapid metabolizer).
- A subject with AST and ALT levels exceeding 3 times of the upper limit of the reference range in the screening test.
- A subject with a history of excessive caffeine (> 5 units/day) or regular alcohol consumption exceeding 210 g/week within 6 months of screening test. (1 glass of beer (5%) (250 mL) = 10 g, 1 shot of soju (20%) (50 mL) = 8 g, 1 glass of wine (12%) (125 mL) = 12 g)
- A subject who participated in other clinical trial or bioequivalence study and administered the study medication within 6 months prior to the first administration of the investigational product of this study.
Show all 16Show fewer
- A subject with significant alcohol or drug abuse within a year of screening test.
- A subject who administered drugs that significantly induce or inhibit drug metabolizing enzymes within 30 days prior to the first administration of the investigational product of this study.
- A subject who smoked cigarettes more than 20 per day within 6 months of screening test.
- A subject who administered prescribed drug or over-the-counter drug within 10 days prior to the first administration of the investigational product of this study.
- A subject who has donated whole blood within 2 months or those who donated the component blood within 1 month prior to the first administration of the investigational product of this study.
- A subject who has hypersensitivity to the investigational product of this study, benzimidazoles, penicillin and macrolide and its related medical history.
- A subject with rare genetic problems such as fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency.
- Pregnant or nursing women
- A subject who cannot use reliable contraception during the entire period of the clinical trial (e.g, condom use, intrauterine device, tubal ligation, cervical cap, contraceptive diaphragm, etc.).
- A subject who is judged by the investigator to be ineligible to participate in the test.
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: An Open-label, Randomized, Crossover Study to Evaluate the Pharmacodynamics After Single Oral Dosing of Tegoprazan, EAPA115 and RAPA115 in Healthy Volunteers
This study aims to evaluate the pharmacodynamics after single oral dosing of tegoprazan, EAPA115 and RAPA115 in healthy volunteers.
Read the detailed description
Evaluation Criteria
- Pharmacodynamic assessments with intragastric pH
- Safety assessments with adverse event monitoring including subjective/objective symptoms, physical examination, vital signs, electrocardiogram, and laboratory test
- Conditions
- Healthy
- Being tested
- Tegoprazan 50 mg, EAPA115, RAPA115
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tegoprazan 50 mgDrug
Also called K-CAB
Tegoprazan 50 mg tablet
EAPA115Drug
EAPA115
RAPA115Drug
RAPA115
| Study group | Role | What they receive |
|---|---|---|
| Tegoprazan 50 mg | Experimental | Oral administration of Tegoprazan 50 mg tablet once a day Receives: Drug: Tegoprazan 50 mg |
| EAPA115 | Active comparator | Oral administration of EAPA115 once a day Receives: Drug: EAPA115 |
| RAPA115 | Active comparator | Oral administration of RAPA115 once a day Receives: Drug: RAPA115 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacodynamic Evaluation
The ratio of duration(Duration %) with pH ≥ 4 over 24 hours
Measured: Pre-dose(0 hour) up to 24 hours after Investigational product administration in each period
Pharmacodynamic Evaluation
The ratio of duration(Duration %) with pH ≥ 6 over 24 hours
Measured: Pre-dose(0 hour) up to 24 hours after Investigational product administration in each period
Pharmacodynamic Evaluation
Median pH
Measured: Pre-dose(0 hour) up to 24 hours after Investigational product administration in each period
Pharmacodynamic Evaluation
Mean pH
Measured: Pre-dose(0 hour) up to 24 hours after Investigational product administration in each period
Pharmacodynamic Evaluation
Baseline pH and changes in pH after the administration of investigational products (change of duration %, change of mean pH, change of median pH)
Measured: Pre-dose(0 hour) up to 24 hours after Investigational product administration in each period
Pharmacodynamic Evaluation
The ratio of duration(Duration %) with pH ≥ 4 during nocturnal period* (*12 hours after administration of investigational product)
Measured: Pre-dose(0 hour) up to 12 hours after Investigational product administration in each period
Pharmacodynamic Evaluation
The ratio of duration(Duration %) with pH ≥ 6 during nocturnal period* (*12 hours after administration of investigational product)
Measured: Pre-dose(0 hour) up to 12 hours after Investigational product administration 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 posted18 Jan 2020
- Study start14 Jan 2020
- Primary completion29 Jul 2020
- Study completion3 Aug 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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- In-Jin Jang, MD, PhD, Principal investigator, Seoul National University Hospital, Dept. of Clinical Pharmacology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04231136
- Sponsor's protocol ID
- CJ_APA_115
- Status last verified
- Jan 2020
- First submitted
- 9 Jan 2020
- Last updated
- 1 Dec 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 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Crossover Study to Evaluate the Pharmacodynamics After Single Oral Dosing of Tegoprazan, EAPA115 and RAPA115 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04231136
- Acronym / sponsor ID
- CJ_APA_115
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- 14 Jan 2020 (actual)
- Primary completion
- 29 Jul 2020 (actual)
- Study completion
- 3 Aug 2020 (actual)
- First posted
- 18 Jan 2020 (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 pharmacodynamics after single oral dosing of tegoprazan, EAPA115 and RAPA115 in healthy volunteers.
Detailed description
Evaluation Criteria
- Pharmacodynamic assessments with intragastric pH
- 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 |
|---|---|---|
| Tegoprazan 50 mg | Experimental | Drug: Tegoprazan 50 mgOral administration of Tegoprazan 50 mg tablet once a day |
| EAPA115 | Active comparator | Drug: EAPA115Oral administration of EAPA115 once a day |
| RAPA115 | Active comparator | Drug: RAPA115Oral administration of RAPA115 once a day |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy adults aged 19 to 65 years (not inclusive) at the time of signing the informed consent form (ICF).
- Body mass index (BMI) ≥ 17.5 and < 30.5 kg/m^2 with a body weight ≥ 45 kg at screening. Body mass index (kg/m^2) = weight (kg)/height (m)^2
- Confirmed as H. pylori negative
- A subject without any congenital or chronic disease within 3 years, and has no medical examination result as pathological symptoms or signs.
- A subject determined eligible for this study based on the screening test such as clinical laboratory tests (hematology test, chemistry test, urine test, virus/bacteria test, etc.), vital signs, and electrocardiogram.
Key exclusion criteria (16 listed)
- A subject with clinically significant blood, renal, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, hepatic, psychical, neurologic, or immunologic diseases (except for simple dental past history such as tartar, impacted tooth, or wisdom tooth) or evidence.
- A subject with a history of gastrointestinal disorders (esophageal diseases such as esophageal achalasia or esophageal stricture, Crohn's disease) or surgery (except for simple appendectomy, herniotomy, and tooth extraction surgery) that may affect the absorption of drugs.
- A subject with the *17 allele of CYP2C19 (Ultrarapid metabolizer).
- A subject with AST and ALT levels exceeding 3 times of the upper limit of the reference range in the screening test.
- A subject with a history of excessive caffeine (> 5 units/day) or regular alcohol consumption exceeding 210 g/week within 6 months of screening test. (1 glass of beer (5%) (250 mL) = 10 g, 1 shot of soju (20%) (50 mL) = 8 g, 1 glass of wine (12%) (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 50 mgAlso: K-CABTegoprazan 50 mg tablet | Drug | Tegoprazan 50 mg |
| EAPA115EAPA115 | Drug | EAPA115 |
| RAPA115RAPA115 | Drug | RAPA115 |
Primary outcome
Pharmacodynamic Evaluation
Time frame: Pre-dose(0 hour) up to 24 hours after Investigational product administration in each period
The ratio of duration(Duration %) with pH ≥ 4 over 24 hours
Pharmacodynamic Evaluation
Time frame: Pre-dose(0 hour) up to 24 hours after Investigational product administration in each period
The ratio of duration(Duration %) with pH ≥ 6 over 24 hours
Pharmacodynamic Evaluation
Time frame: Pre-dose(0 hour) up to 24 hours after Investigational product administration in each period
Median pH
Pharmacodynamic Evaluation
Time frame: Pre-dose(0 hour) up to 24 hours after Investigational product administration in each period
Mean pH
Pharmacodynamic Evaluation
Time frame: Pre-dose(0 hour) up to 24 hours after Investigational product administration in each period
Baseline pH and changes in pH after the administration of investigational products (change of duration %, change of mean pH, change of median pH)
Pharmacodynamic Evaluation
Time frame: Pre-dose(0 hour) up to 12 hours after Investigational product administration in each period
The ratio of duration(Duration %) with pH ≥ 4 during nocturnal period* (*12 hours after administration of investigational product)
Pharmacodynamic Evaluation
Time frame: Pre-dose(0 hour) up to 12 hours after Investigational product administration in each period
The ratio of duration(Duration %) with pH ≥ 6 during nocturnal period* (*12 hours after administration of investigational product)
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 1 Dec 2020.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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, MD, PhD 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 Tegoprazan 50 mg, EAPA115 and RAPA115 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 16 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 1 Dec 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?
Pharmacodynamic Evaluation (time frame: Pre-dose(0 hour) up to 24 hours after Investigational product administration in each period). The study lists 7 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 1 Dec 2020.