PharmacodynamicsPhase 1NCT03530228
A Phase 1 Study of Tegoprazan on Healthy Male Volunteers
A Phase 1 study testing Tegoprazan (C1), Treatment C: Tegoprazan (C1) and Tegoprazan (C2) in people with Pharmacodynamics and Pharmacokinetics, run by HK inno.N Corporation at 1 site in South Korea.
Trial summary
A randomized, open-label, active-controlled, single/multiple-dose phase 1 clinical trial to evaluate pharmacokinetics/pharmacodynamics and safety/tolerability of tegoprazan after oral administration in healthy male subjects 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
- Pharmacodynamics, Pharmacokinetics, Healthy Male Volunteers
- What is being tested?
- Tegoprazan (C1), Treatment C: Tegoprazan (C1) and Tegoprazan (C2)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2018to Aug 2018
- 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
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, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
In Jin Jang, MD, PhD, 82-2-2072-1666, ijjang@snu.ac.kr
Mu Seong Ban, MD, 82-2-2072-1666, ban2699@snu.ac.kr
About this study
Official title: A Randomized, Open-label, Active-controlled, Single/Multiple-dose Phase 1 Clinical Trial to Evaluate Pharmacokinetics/Pharmacodynamics and Safety/Tolerability of Tegoprazan After Oral Administration in Healthy Male Subjects
A randomized, open-label, active-controlled, single/multiple-dose phase 1 clinical trial to evaluate pharmacokinetics/pharmacodynamics and safety/tolerability of tegoprazan after oral administration in healthy male subjects
Read the detailed description
- To evaluate the pharmacokinetics and pharmacodynamics of single oral dose of tegoprazan between dose groups in healthy H. pylori negative males.
- To evaluate the pharmacokinetics and pharmacodynamics of multiple oral dose of tegoprazan under the fed state in healthy H. pylori negative males.
- To evaluate the pharmacokinetics and pharmacodynamics of single oral dose of tegoprazan in healthy H. pylori positive males.
- Conditions
- Pharmacodynamics, Pharmacokinetics, Healthy Male Volunteers
- Being tested
- Tegoprazan (C1), Treatment C: Tegoprazan (C1), Tegoprazan (C2), Esomeprazole (C2), Tegoprazan (C3)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tegoprazan (C1)Drug
Tegoprazan QD, oral administration. Treatment A
Tegoprazan (C1)Drug
Tegoprazan QD, oral administration. Treatment B
Treatment C: Tegoprazan (C1)Drug
Tegoprazan BID, oral administration
Tegoprazan (C2)Drug
Tegoprazan QD, oral administration, for 7 days. Group 1
Tegoprazan (C2)Drug
Tegoprazan QD, oral administration, for 7 days. Group 2
Esomeprazole (C2)Drug
Esomeprazole QD, oral administration, for 7 days. Group 3
Tegoprazan (C3)Drug
Tegoprazan QD, oral administration
| Study group | Role | What they receive |
|---|---|---|
| Treatment A: Tegoprazan (C1) | Experimental | Tegoprazan QD, oral administration Receives: Drug: Tegoprazan (C1) |
| Treatment B: Tegoprazan (C1) | Experimental | Tegoprazan QD, oral administration Receives: Drug: Tegoprazan (C1) |
| Treatment C: Tegoprazan (C1) | Experimental | Tegoprazan BID, oral administration Receives: Drug: Treatment C: Tegoprazan (C1) |
| Group 1: Tegoprazan (C2) | Experimental | Tegoprazan QD, oral administration, for 7 days Receives: Drug: Tegoprazan (C2) |
| Group 2: Tegoprazan (C2) | Experimental | Tegoprazan QD, oral administration, for 7 days Receives: Drug: Tegoprazan (C2) |
| Group 3: Esomeprazole (C2) | Active comparator | Esomeprazole QD, oral administration, for 7 days Receives: Drug: Esomeprazole (C2) |
| Tegoprazan (C3) | Experimental | Tegoprazan QD, oral administration Receives: Drug: Tegoprazan (C3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC(0-24h) of tegoprazan
Area Under the Curve(0-24h) of tegoprazan
Measured: up to 7 days
Cmax of tegoprazan
Maximum Plasma Concentration of tegoprazan
Measured: up to 7 days
Gastric pH
Gastric pH
Measured: up to 7 days
Serum gastrin concentration
Serum gastrin concentration
Measured: up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study startMay 2018 (estimated)
- Primary completionAug 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacodynamicsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Cohort 1: crossover Cohort 2: parallel Cohort 3: single group
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03530228
- Sponsor's protocol ID
- CJ_APA_109
- Status last verified
- May 2018
- First submitted
- 8 May 2018
- Last updated
- 21 May 2018
- 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 21 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Active-controlled, Single/Multiple-dose Phase 1 Clinical Trial to Evaluate Pharmacokinetics/Pharmacodynamics and Safety/Tolerability of Tegoprazan After Oral Administration in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03530228
- Acronym / sponsor ID
- CJ_APA_109
- Conditions
- Pharmacodynamics, Pharmacokinetics, Healthy Male Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2018 (estimated)
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 21 May 2018 (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.
A randomized, open-label, active-controlled, single/multiple-dose phase 1 clinical trial to evaluate pharmacokinetics/pharmacodynamics and safety/tolerability of tegoprazan after oral administration in healthy male subjects
Detailed description
- To evaluate the pharmacokinetics and pharmacodynamics of single oral dose of tegoprazan between dose groups in healthy H. pylori negative males.
- To evaluate the pharmacokinetics and pharmacodynamics of multiple oral dose of tegoprazan under the fed state in healthy H. pylori negative males.
- To evaluate the pharmacokinetics and pharmacodynamics of single oral dose of tegoprazan in healthy H. pylori positive males.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 7
- Model description
- Cohort 1: crossover Cohort 2: parallel Cohort 3: single group
| Arm | Type | Receives |
|---|---|---|
| Treatment A: Tegoprazan (C1) | Experimental | Drug: Tegoprazan (C1)Tegoprazan QD, oral administration |
| Treatment B: Tegoprazan (C1) | Experimental | Drug: Tegoprazan (C1)Tegoprazan QD, oral administration |
| Treatment C: Tegoprazan (C1) | Experimental | Drug: Treatment C: Tegoprazan (C1)Tegoprazan BID, oral administration |
| Group 1: Tegoprazan (C2) | Experimental | Drug: Tegoprazan (C2)Tegoprazan QD, oral administration, for 7 days |
| Group 2: Tegoprazan (C2) | Experimental | Drug: Tegoprazan (C2)Tegoprazan QD, oral administration, for 7 days |
| Group 3: Esomeprazole (C2) | Active comparator | Drug: Esomeprazole (C2)Esomeprazole QD, oral administration, for 7 days |
| Tegoprazan (C3) | Experimental | Drug: Tegoprazan (C3)Tegoprazan QD, oral administration |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 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
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 (C1)Tegoprazan QD, oral administration. Treatment A | Drug | Treatment A: Tegoprazan (C1) |
| Tegoprazan (C1)Tegoprazan QD, oral administration. Treatment B | Drug | Treatment B: Tegoprazan (C1) |
| Treatment C: Tegoprazan (C1)Tegoprazan BID, oral administration | Drug | Treatment C: Tegoprazan (C1) |
| Tegoprazan (C2)Tegoprazan QD, oral administration, for 7 days. Group 1 | Drug | Group 1: Tegoprazan (C2) |
| Tegoprazan (C2)Tegoprazan QD, oral administration, for 7 days. Group 2 | Drug | Group 2: Tegoprazan (C2) |
| Esomeprazole (C2)Esomeprazole QD, oral administration, for 7 days. Group 3 | Drug | Group 3: Esomeprazole (C2) |
| Tegoprazan (C3)Tegoprazan QD, oral administration | Drug | Tegoprazan (C3) |
Primary outcome
AUC(0-24h) of tegoprazan
Time frame: up to 7 days
Area Under the Curve(0-24h) of tegoprazan
Cmax of tegoprazan
Time frame: up to 7 days
Maximum Plasma Concentration of tegoprazan
Gastric pH
Time frame: up to 7 days
Gastric pH
Serum gastrin concentration
Time frame: up to 7 days
Serum gastrin concentration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2018.
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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.
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 (C1), Treatment C: Tegoprazan (C1) and Tegoprazan (C2) in people with Pharmacodynamics and Pharmacokinetics, 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 2 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: status not confirmed, as of the sponsor's last update on 21 May 2018. 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 In Jin Jang, MD, PhD (82-2-2072-1666, ijjang@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC(0-24h) of tegoprazan (time frame: up to 7 days). 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 21 May 2018.