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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy; Hepatic Impairment
• Intervention / Treatment: Drug: Tegoprazan 50mg

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 Type: Interventional
• Enrollment (Anticipated): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Incheon, Korea, Republic of
    • Recruiting
    • Gachon University Gil Medical Center
  • Seongnam-si, Korea, Republic of
    • Recruiting
    • Cha Bundang Medical Center
  • Seoul, Korea, Republic of
    • Recruiting
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

[Healthy Control Group]

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).

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]

Inclusion Criteria:

• 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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Subjects with normal hepatic function; Single dose of Tegoprazan 50mg	Drug: Tegoprazan 50mg; Oral administration once daily; Other Names: K-CAB
EXPERIMENTAL: Subjects with mild hepatic impairment; Single dose of Tegoprazan 50mg	Drug: Tegoprazan 50mg; Oral administration once daily; Other Names: K-CAB
EXPERIMENTAL: Subjects with moderate hepatic impairment; Single dose of Tegoprazan 50mg	Drug: Tegoprazan 50mg; Oral administration once daily; Other Names: K-CAB
EXPERIMENTAL: Subjects with severe hepatic impairment; Single dose of Tegoprazan 50mg	Drug: Tegoprazan 50mg; Oral administration once daily; Other Names: K-CAB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic Assessment	AUClast of tegoprazan and M1	Up to 48 hours
Pharmacokinetic Assessment	Cmax of tegoprazan and M1	Up to 48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic Assessment	CL/F of tegoprazan	Up to 48 hours
Pharmacokinetic Assessment	t½ of tegoprazan	Up to 48 hours
Pharmacokinetic Assessment	AUCinf of tegoprazan	Up to 48 hours
Pharmacokinetic Assessment	fu of tegoprazan	Up to 48 hours
Pharmacokinetic Assessment	CLrenal of tegoprazan and M1	Up to 48 hours
Pharmacokinetic Assessment	Ae of tegoprazan and M1	Up to 48 hours

Collaborators and Investigators

• Sponsor: HK inno.N Corporation
• Investigators: Study Chair: Jung-Ryul Kim, MD, PhD, Samsung Medical Center; Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 8, 2020
• Primary Completion (ANTICIPATED): June 1, 2023
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: July 28, 2020
• First Submitted That Met QC Criteria: July 28, 2020
• First Posted (ACTUAL): July 31, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 9, 2020
• Last Update Submitted That Met QC Criteria: November 5, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: IN_APA_116

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No