Hepatic ImpairmentPhase 1NCT04494269
A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls
A Phase 1 study testing Tegoprazan 50mg in people with Hepatic Impairment and Healthy, run by HK inno.N Corporation at 3 sites in South Korea.
Trial summary
The main purpose of this study is to compare the pharmacokinetic and safety of tegoprazan following single oral dose in subjects with hepatic impairment versus healthy control. Read more about this study
- Who is it for?
- Ages 19 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment, 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
- 28 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 8 Sep 2020to Dec 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects aged 19 to 70(inclusive) years at the time of signing the informed consent form.
- Subjects with a body weight of ≥ 50 kg and ≤ 90 kg at screening.
- Subjects with AST, ALT, and ALP levels of ≤ 1.5 × upper limit of the normal reference range (ULN) with total bilirubin < 2 mg/dL and PT (INR) < 1.7 at screening.
- Subjects who have no chronic disease or any congenital disease within the last 5 years and no pathological symptoms or findings as a result of an internal examination
- Subjects who provide voluntary written informed consent to study participation after being informed of detailed explanation and fully understanding study objectives, procedures and characteristics of the investigational product(IP).
- Subjects with chronic liver disease who meet any of the followings:
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- Chronic Hepatitis B;
- Chronic Hepatitis C;
- Alcoholic liver disease;
- Non-alcoholic fatty liver disease; or
- Liver fibrosis and cirrhosis.
- Subjects aged 19 to 70 years (inclusive) at the time of signing the informed consent form.
- Subjects with body weight of ≥ 50 kg and ≤ 90 kg with a BMI of ≥ 18.0 kg/m2 and ≤ 30 kg/m2 at screening.
- Subjects who meet any of following criteria:
- AST, ALT, or ALP level > 1.5 × ULN at screening;
- Total bilirubin ≥ 2 mg/dL at screening; or
- PT (INR) ≥ 1.7 at screening.
- Subjects who provide voluntary written informed consent to study participation after being informed of detailed explanation and fully understanding study objectives, procedures and characteristics of the IP.
Who cannot join
- Subjects who show symptoms of acute disease at the time of screening.
- Subjects with any clinically significant disease related to ongoing cardiovascular problem, respiratory system, kidney, endocrine system, hematologic, central nervous system, mental health disorder, or malignant tumor.
- Subjects with history or current evidence of gastrointestinal or hepatobiliary disease which may affect PK evaluation of the IP.
- Subjects with history or current evidence of clinically significant hypersensitivity to drugs containing any ingredient of proton pump inhibitors or potassium-competitive acid blockers and other drugs (such as aspirin and antibiotics).
- Subjects with systolic blood pressure (BP) of < 90 mmHg or > 160 mmHg, or diastolic BP of < 50 mmHg or > 100 mmHg at screening.
- Subjects who have received medication or food which may significantly affect absorption, distribution, metabolism, or elimination of study drug within 7 days prior to scheduled study treatment.
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- Subjects who have participated in any other clinical study or bioequivalence study and received investigational agent within 180 days prior to scheduled study treatment.
- Subjects who have donated whole blood within 60 days prior to the scheduled study treatment, or has donated blood components or received transfusion within 30 days prior to scheduled study treatment.
- Subjects who are unable to use a medically acceptable contraceptive method throughout the study.
- Subjects who are determined ineligible for study participation by the investigator for other reasons.
- [Subjects with Hepatic Impairment]
- Subjects who show symptoms of acute disease at the time of screening.
- Subjects with any clinically significant disease related to ongoing cardiovascular problem, respiratory system, kidney, endocrine system, hematologic, central nervous system, mental health disorder, or malignant tumor.
- Subjects with a history or current evidence of gastrointestinal disease which may affect PK evaluation for the IP.
- Subjects who have clinical changes to an estimated level that may affect PK evaluation of the study drug within 30 days prior to the scheduled dosing date.
- Changes in existing medications including dosage regimen within 30 days prior to the scheduled dosing date.
- Subjects with prior history or current evidence of clinically significant hypersensitivity to drugs containing any ingredient of proton pump inhibitors or potassium-competitive acid blockers and other drugs (such as aspirin and antibiotics).
- Systolic BP of < 90 mmHg or > 160 mmHg, or diastolic BP of < 50 mmHg or > 100 mmHg at screening.
- Any concomitant medications or foods which may significantly affect absorption, distribution, metabolism, or elimination of the study drug within 7 days prior to the scheduled dosing date.
- Subjects who have participated in any other clinical study or bioequivalence study and received investigational agent within 180 days prior to scheduled study treatment.
- Subjects who have donated whole blood within 60 days prior to the scheduled dosing date, or have donated blood components or received transfusion within 30 days prior to the scheduled dosing date.
- Subjects who are unable to use medically acceptable contraceptive methods throughout the study.
- Subjects who are determined to be ineligible for study participation by the investigator for other reasons.
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites, 3 recruiting
- Recruiting
Gachon University Gil Medical Center
Incheon
- Recruiting
CHA Bundang Medical Center
Seongnam-si
- Recruiting
Samsung Medical Center
Seoul
About this study
Official title: An Open-label, Multi-center, Single-dose, Parallel-group Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls
The main purpose of this study is to compare the pharmacokinetic and safety of tegoprazan following single oral dose in subjects with hepatic impairment versus healthy control.
Read the detailed description
[Pharmacokinetic Assessment]
- Measurements
- Tegoprazan and desmethyl tegoprazan (M1) in blood and urine
- Endpoints
- Primary endpoints: AUClast and Cmax of tegoprazan and M1
- Secondary endpoints: CL/F, t1/2, AUCinf, and fu of tegoprazan; CLrenal and Ae of tegoprazan and M1
[Safety Assessment]
- Adverse events (AEs)
- Clinical laboratory tests
- Vital sign
- Physical examination
- Electrocardiogram (ECG)
- Conditions
- Hepatic Impairment, 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 K-CAB
Oral administration once daily
| Study group | Role | What they receive |
|---|---|---|
| Subjects with normal hepatic function | Active comparator | Single dose of Tegoprazan 50mg Receives: Drug: Tegoprazan 50mg |
| Subjects with mild hepatic impairment | Experimental | Single dose of Tegoprazan 50mg Receives: Drug: Tegoprazan 50mg |
| Subjects with moderate hepatic impairment | Experimental | Single dose of Tegoprazan 50mg Receives: Drug: Tegoprazan 50mg |
| Subjects with severe hepatic impairment | Experimental | Single dose of Tegoprazan 50mg Receives: Drug: Tegoprazan 50mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic Assessment
AUClast of tegoprazan and M1
Measured: Up to 48 hours
Pharmacokinetic Assessment
Cmax of tegoprazan and M1
Measured: Up to 48 hours
Secondary outcomes (6)
Pharmacokinetic Assessment
CL/F of tegoprazan
Measured: Up to 48 hours
Pharmacokinetic Assessment
t½ of tegoprazan
Measured: Up to 48 hours
Pharmacokinetic Assessment
AUCinf of tegoprazan
Measured: Up to 48 hours
Pharmacokinetic Assessment
fu of tegoprazan
Measured: Up to 48 hours
Pharmacokinetic Assessment
CLrenal of tegoprazan and M1
Measured: Up to 48 hours
Pharmacokinetic Assessment
Ae of tegoprazan and M1
Measured: Up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start8 Sep 2020
- Primary completionJun 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatic ImpairmentStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jung-Ryul Kim, MD, PhD, Study chair, Samsung Medical CenterYang-Won Min, MD, PhD, Principal investigator, Samsung Medical CenterDong-Seong Shin, MD, PhD, Principal investigator, Gachon University Gil Medical CenterEon-Hye Kim, MD, PhD, Principal investigator, CHA Bundang Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04494269
- Sponsor's protocol ID
- IN_APA_116
- Status last verified
- Jul 2020
- First submitted
- 28 Jul 2020
- Last updated
- 9 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kim A, Shin D, Seo Y, Kang D, Min YW, Kim IH, Kim J. Phase I Study to Evaluate the Effect of Hepatic Impairment on Pharmacokinetics and Safety of Tegoprazan, a Potassium Competitive Acid Blocker. Adv Ther. 2025 Mar;42(3):1570-1581. doi: 10.1007/s12325-025-03127-5. Epub 2025 Feb 11.
PubMed 39932678
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-center, Single-dose, Parallel-group Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls
- ClinicalTrials.gov ID
- NCT04494269
- Acronym / sponsor ID
- IN_APA_116
- Conditions
- Hepatic Impairment, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 31 Jul 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.
The main purpose of this study is to compare the pharmacokinetic and safety of tegoprazan following single oral dose in subjects with hepatic impairment versus healthy control.
Detailed description
[Pharmacokinetic Assessment]
- Measurements
- Tegoprazan and desmethyl tegoprazan (M1) in blood and urine
- Endpoints
- Primary endpoints: AUClast and Cmax of tegoprazan and M1
- Secondary endpoints: CL/F, t1/2, AUCinf, and fu of tegoprazan; CLrenal and Ae of tegoprazan and M1
[Safety Assessment]
- Adverse events (AEs)
- Clinical laboratory tests
- Vital sign
- Physical examination
- Electrocardiogram (ECG)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Subjects with normal hepatic function | Active comparator | Drug: Tegoprazan 50mgSingle dose of Tegoprazan 50mg |
| Subjects with mild hepatic impairment | Experimental | Drug: Tegoprazan 50mgSingle dose of Tegoprazan 50mg |
| Subjects with moderate hepatic impairment | Experimental | Drug: Tegoprazan 50mgSingle dose of Tegoprazan 50mg |
| Subjects with severe hepatic impairment | Experimental | Drug: Tegoprazan 50mgSingle dose of Tegoprazan 50mg |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Subjects aged 19 to 70(inclusive) years at the time of signing the informed consent form.
- Subjects with a body weight of ≥ 50 kg and ≤ 90 kg at screening.
- Subjects with AST, ALT, and ALP levels of ≤ 1.5 × upper limit of the normal reference range (ULN) with total bilirubin < 2 mg/dL and PT (INR) < 1.7 at screening.
- Subjects who have no chronic disease or any congenital disease within the last 5 years and no pathological symptoms or findings as a result of an internal examination
- Subjects who provide voluntary written informed consent to study participation after being informed of detailed explanation and fully understanding study objectives, procedures and characteristics of the investigational product(IP).
Key exclusion criteria (23 listed)
- Subjects who show symptoms of acute disease at the time of screening.
- Subjects with any clinically significant disease related to ongoing cardiovascular problem, respiratory system, kidney, endocrine system, hematologic, central nervous system, mental health disorder, or malignant tumor.
- Subjects with history or current evidence of gastrointestinal or hepatobiliary disease which may affect PK evaluation of the IP.
- Subjects with history or current evidence of clinically significant hypersensitivity to drugs containing any ingredient of proton pump inhibitors or potassium-competitive acid blockers and other drugs (such as aspirin and antibiotics).
- Subjects with systolic blood pressure (BP) of < 90 mmHg or > 160 mmHg, or diastolic BP of < 50 mmHg or > 100 mmHg 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 |
|---|---|---|
| Tegoprazan 50mgAlso: K-CABOral administration once daily | Drug | Subjects with mild hepatic impairment, Subjects with moderate hepatic impairment, Subjects with normal hepatic function, Subjects with severe hepatic impairment |
Primary outcome
Pharmacokinetic Assessment
Time frame: Up to 48 hours
AUClast of tegoprazan and M1
Pharmacokinetic Assessment
Time frame: Up to 48 hours
Cmax of tegoprazan and M1
6 secondary outcomes
Pharmacokinetic Assessment
Time frame: Up to 48 hours
Pharmacokinetic Assessment
Time frame: Up to 48 hours
Pharmacokinetic Assessment
Time frame: Up to 48 hours
Pharmacokinetic Assessment
Time frame: Up to 48 hours
Pharmacokinetic Assessment
Time frame: Up to 48 hours
Pharmacokinetic Assessment
Time frame: Up to 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
- Derived from this study: PubMed 39932678Kim A, Shin D, Seo Y, Kang D, Min YW, Kim IH, Kim J. Phase I Study to Evaluate the Effect of Hepatic Impairment on Pharmacokinetics and Safety of Tegoprazan, a Potassium Competitive Acid Blocker. Adv Ther. 2025 Mar;42(3):1570-1581. doi: 10.1007/s12325-025-03127-5. Epub 2025 Feb 11.
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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.
Jung-Ryul Kim, MD, PhD study chair
Samsung Medical Center
Yang-Won Min, MD, PhD principal investigator
Samsung Medical Center
Dong-Seong Shin, MD, PhD principal investigator
Gachon University Gil Medical Center
3 sites 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 Hepatic Impairment and Healthy, run by HK inno.N Corporation at 3 sites 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 18 inclusion and 23 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 9 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Youngshin Keum, R.Ph, Pharm.D (+82-2-6477-0204, ys.keum@inno-n.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic Assessment (time frame: Up to 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04494269, which also lists 1 linked publication.
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 9 Nov 2020.