Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04494269
Other study ID # IN_APA_116
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date September 8, 2020
Est. completion date December 2023

Study information

Verified date July 2020
Source HK inno.N Corporation
Contact Youngshin Keum, R.Ph, Pharm.D
Phone +82-2-6477-0204
Email ys.keum@inno-n.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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)


Recruitment information / eligibility

Status Recruiting
Enrollment 28
Est. completion date December 2023
Est. primary completion date June 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 70 Years
Eligibility [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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Tegoprazan 50mg
Oral administration once daily

Locations

Country Name City State
Korea, Republic of Gachon University Gil Medical Center Incheon
Korea, Republic of CHA Bundang Medical Center Seongnam-si
Korea, Republic of Samsung Medical Center Seoul

Sponsors (1)

Lead Sponsor Collaborator
HK inno.N Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pharmacokinetic Assessment AUClast of tegoprazan and M1 Up to 48 hours
Primary Pharmacokinetic Assessment Cmax of tegoprazan and M1 Up to 48 hours
Secondary Pharmacokinetic Assessment CL/F of tegoprazan Up to 48 hours
Secondary Pharmacokinetic Assessment t½ of tegoprazan Up to 48 hours
Secondary Pharmacokinetic Assessment AUCinf of tegoprazan Up to 48 hours
Secondary Pharmacokinetic Assessment fu of tegoprazan Up to 48 hours
Secondary Pharmacokinetic Assessment CLrenal of tegoprazan and M1 Up to 48 hours
Secondary Pharmacokinetic Assessment Ae of tegoprazan and M1 Up to 48 hours
See also
  Status Clinical Trial Phase
Recruiting NCT06052553 - A Study of TopSpin360 Training Device N/A
Completed NCT05511077 - Biomarkers of Oat Product Intake: The BiOAT Marker Study N/A
Recruiting NCT04632485 - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed NCT05931237 - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults N/A
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04527718 - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers Phase 1
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Terminated NCT05934942 - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood Phase 1
Recruiting NCT05525845 - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI N/A
Completed NCT05515328 - A Study in Healthy Men to Test How BI 685509 is Processed in the Body Phase 1
Completed NCT05030857 - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects Phase 1
Completed NCT04967157 - Cognitive Effects of Citicoline on Attention in Healthy Men and Women N/A
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Completed NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1
Completed NCT04052711 - A Randomized, Controlled Study to Evaluate the Sensitizing Potential of FMX-101 in Healthy Volunteers Using a Repeat Insult Patch Test Design Phase 1