HealthyPhase 1NCT03863938
Food-Effect on PK and PD of Single Oral Dose of Tegoprazan in Healthy Male Subjects
A Phase 1 study testing Tegoprazan 50mg in people with Healthy, run by HK inno.N Corporation at 1 site in South Korea.
Trial summary
This study aims to evaluate the food-effect of tegoprazan 50mg on the pharmacokinetics and pharmacodynamics in healthy H. pylori negative 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?
- Tegoprazan 50mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Mar 2019to 25 Jun 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
- 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
Who cannot join
- Presence or history of clinically significant diseases
- Presence or history of gastrointestinal disorder (gastric ulcer, GERD, Crohn's disease, etc.)
- Hypersensitivity to drugs containing study drug or proton pump inhibitor and other drugs (aspirin, antibiotics, etc.) or history of clinically significant hypersensitivity
- Serologic test positive
- Abnormal obstacle to insertion and maintenance of pH meter catheter
- History of drug abuse
- Excessive caffeine intake or persistent alcohol intake
- Not use of a medically acceptable method of contraception
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, Single-dose Phase 1 Clinical Trial to Compare the Effect of Timing of Food on the Pharmacokinetics and Pharmacodynamics of K-CAB (Tegoprazan) in Healthy Male Subjects
This study aims to evaluate the food-effect of tegoprazan 50mg on the pharmacokinetics and pharmacodynamics in healthy H. pylori negative male volunteers
Read the detailed description
Primary Outcome Measure:
- AUClast and Cmax of tegaprazan
- Gastric pH
- Conditions
- Healthy
- Being tested
- Tegoprazan 50mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tegoprazan 50mgDrug
Also called Tegoprazan 50mg tablet
K-CAB
| Study group | Role | What they receive |
|---|---|---|
| Tegoprazan 50mg under fasting condition | Experimental | Treatment A: single oral administration of Tegoprazan 50mg tablet under fasting condition once a day Receives: Drug: Tegoprazan 50mg |
| Tegoprazan 50mg before the meal | Experimental | Treatment B: single oral administration of Tegoprazan 50mg tablet before the meal once a day Receives: Drug: Tegoprazan 50mg |
| Tegoprazan 50mg after the meal | Experimental | Treatment C: single oral administration of Tegoprazan 50mg tablet after the meal once a day Receives: Drug: Tegoprazan 50mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUClast of tegaprazan
Area under the plasma concentration versus time curve of tegoprazan
Measured: Pre-dose(0 hour) and up to 48 hours in each period
Cmax of tegaprazan
Peak Plasma Concentration of tegoprazan
Measured: Pre-dose(0 hour) and up to 48 hours in each period
Gastric pH
Gastric pH
Measured: Pre-dose(0 hour) up to 24 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 posted5 Mar 2019
- Study start27 Mar 2019
- Primary completion26 Apr 2019
- Study completion25 Jun 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
- 12 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
- NCT03863938
- Sponsor's protocol ID
- CJ_APA_112
- Status last verified
- Aug 2019
- First submitted
- 28 Feb 2019
- Last updated
- 22 Aug 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 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single-dose Phase 1 Clinical Trial to Compare the Effect of Timing of Food on the Pharmacokinetics and Pharmacodynamics of K-CAB (Tegoprazan) in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03863938
- Acronym / sponsor ID
- CJ_APA_112
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- 27 Mar 2019 (actual)
- Primary completion
- 26 Apr 2019 (actual)
- Study completion
- 25 Jun 2019 (actual)
- First posted
- 5 Mar 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 food-effect of tegoprazan 50mg on the pharmacokinetics and pharmacodynamics in healthy H. pylori negative male volunteers
Detailed description
Primary Outcome Measure:
- AUClast and Cmax of tegaprazan
- Gastric pH
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tegoprazan 50mg under fasting condition | Experimental | Drug: Tegoprazan 50mgTreatment A: single oral administration of Tegoprazan 50mg tablet under fasting condition once a day |
| Tegoprazan 50mg before the meal | Experimental | Drug: Tegoprazan 50mgTreatment B: single oral administration of Tegoprazan 50mg tablet before the meal once a day |
| Tegoprazan 50mg after the meal | Experimental | Drug: Tegoprazan 50mgTreatment C: single oral administration of Tegoprazan 50mg tablet after the meal once a day |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adult males aged ≥ 19 years and ≤ 50 years
- 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
Key exclusion criteria (8 listed)
- Presence or history of clinically significant diseases
- Presence or history of gastrointestinal disorder (gastric ulcer, GERD, Crohn's disease, etc.)
- Hypersensitivity to drugs containing study drug or proton pump inhibitor and other drugs (aspirin, antibiotics, etc.) or history of clinically significant hypersensitivity
- Serologic test positive
- Abnormal obstacle to insertion and maintenance of pH meter catheter
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: Tegoprazan 50mg tabletK-CAB | Drug | Tegoprazan 50mg after the meal, Tegoprazan 50mg before the meal, Tegoprazan 50mg under fasting condition |
Primary outcome
AUClast of tegaprazan
Time frame: Pre-dose(0 hour) and up to 48 hours in each period
Area under the plasma concentration versus time curve of tegoprazan
Cmax of tegaprazan
Time frame: Pre-dose(0 hour) and up to 48 hours in each period
Peak Plasma Concentration of tegoprazan
Gastric pH
Time frame: Pre-dose(0 hour) up to 24 hours after Investigational product administration in each period
Gastric pH
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 22 Aug 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, 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 50mg 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 3 inclusion and 8 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 22 Aug 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?
AUClast of tegaprazan (time frame: Pre-dose(0 hour) and up to 48 hours in each period). The study lists 3 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 22 Aug 2019.