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

NCT04494269 | Unknown Phase 1

• 1 other identifier: IN_APA_116
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 3

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.

Conditions

Hepatic Impairment; Healthy

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetic Assessment

  AUClast of tegoprazan and M1

  Up to 48 hours

• Pharmacokinetic Assessment

  Cmax of tegoprazan and M1

  Up to 48 hours

Secondary Outcomes (6)

• Pharmacokinetic Assessment

  Up to 48 hours

• Pharmacokinetic Assessment

  Up to 48 hours

• Pharmacokinetic Assessment

  Up to 48 hours

• Pharmacokinetic Assessment

  Up to 48 hours

• Pharmacokinetic Assessment

  Up to 48 hours

Study Arms (4)

Subjects with normal hepatic function

ACTIVE COMPARATOR

Single dose of Tegoprazan 50mg

Drug: Tegoprazan 50mg

Subjects with mild hepatic impairment

EXPERIMENTAL

Single dose of Tegoprazan 50mg

Drug: Tegoprazan 50mg

Subjects with moderate hepatic impairment

EXPERIMENTAL

Single dose of Tegoprazan 50mg

Drug: Tegoprazan 50mg

Subjects with severe hepatic impairment

EXPERIMENTAL

Single dose of Tegoprazan 50mg

Drug: Tegoprazan 50mg

Interventions

Tegoprazan 50mg DRUG

Oral administration once daily

Also known as: K-CAB

Subjects with mild hepatic impairment; Subjects with moderate hepatic impairment; Subjects with normal hepatic function; Subjects with severe hepatic impairment

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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 with chronic liver disease who meet any of the followings:
• Chronic Hepatitis B;
• Chronic Hepatitis C;
• Alcoholic liver disease;

Sponsors & Collaborators

• HK inno.N Corporation: lead

Study Sites (3)

Gachon University Gil Medical Center

Incheon, South Korea

RECRUITING

CHA Bundang Medical Center

Seongnam-si, South Korea

RECRUITING

Samsung Medical Center

Seoul, South Korea

RECRUITING

Related Publications (1)

• 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.

  PMID: 39932678 DERIVED

MeSH Terms

Interventions

tegoprazan

Study Officials

• Jung-Ryul Kim, MD, PhD

  Samsung Medical Center

  STUDY CHAIR

• Yang-Won Min, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

• Dong-Seong Shin, MD, PhD

  Gachon University Gil Medical Center

  PRINCIPAL INVESTIGATOR

• Eon-Hye Kim, MD, PhD

  CHA Bundang Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Youngshin Keum, R.Ph, Pharm.D

CONTACT

+82-2-6477-0204; ys.keum@inno-n.com

Seokuee Kim, MD, PhD

CONTACT

+82-2-6477-0207; seokuee.kim@inno-n.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: July 31, 2020
• Study Start: September 8, 2020
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: November 9, 2020

Record last verified: 2020-07

Locations

KR (3)