A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls

NCT ID: NCT04494269

Last Updated: 2020-11-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-08
• Study Completion Date: 2023-12-31

Brief 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.

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Subjects with normal hepatic function

Single dose of Tegoprazan 50mg

Group Type: ACTIVE_COMPARATOR

Tegoprazan 50mg

Intervention Type: DRUG

Oral administration once daily

Subjects with mild hepatic impairment

Single dose of Tegoprazan 50mg

Group Type: EXPERIMENTAL

Tegoprazan 50mg

Intervention Type: DRUG

Oral administration once daily

Subjects with moderate hepatic impairment

Single dose of Tegoprazan 50mg

Group Type: EXPERIMENTAL

Tegoprazan 50mg

Intervention Type: DRUG

Oral administration once daily

Subjects with severe hepatic impairment

Single dose of Tegoprazan 50mg

Group Type: EXPERIMENTAL

Tegoprazan 50mg

Intervention Type: DRUG

Oral administration once daily

Interventions

Tegoprazan 50mg

Oral administration once daily

Intervention Type: DRUG

Other Intervention Names

K-CAB

Eligibility Criteria

Inclusion Criteria

• 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:

• 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.

Exclusion Criteria

• 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.
• 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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

HK inno.N Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jung-Ryul Kim, MD, PhD

Role: STUDY_CHAIR

Samsung Medical Center

Yang-Won Min, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Dong-Seong Shin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Gachon University Gil Medical Center

Eon-Hye Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHA Bundang Medical Center

Locations

Gachon University Gil Medical Center

Incheon, , South Korea

Site Status: RECRUITING

CHA Bundang Medical Center

Seongnam-si, , South Korea

Site Status: RECRUITING

Samsung Medical Center

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Youngshin Keum, R.Ph, Pharm.D

Role: CONTACT

Phone: +82-2-6477-0204

Email: ys.keum@inno-n.com

Seokuee Kim, MD, PhD

Role: CONTACT

Phone: +82-2-6477-0207

Email: seokuee.kim@inno-n.com

References

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.

Reference Type: DERIVED

PMID: 39932678 (View on PubMed)

Other Identifiers

IN_APA_116

Identifier Type: -

Identifier Source: org_study_id