Study to Evaluate the Pharmacodynamics After Single Oral Dosing of Tegoprazan, EAPA115 and RAPA115 in Healthy Volunteers

An Open-label, Randomized, Crossover Study to Evaluate the Pharmacodynamics After Single Oral Dosing of Tegoprazan, EAPA115 and RAPA115 in Healthy Volunteers

This study aims to evaluate the pharmacodynamics after single oral dosing of tegoprazan, EAPA115 and RAPA115 in healthy volunteers.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Tegoprazan 50 mg; Drug: EAPA115; Drug: RAPA115

Detailed Description

Evaluation Criteria

• Pharmacodynamic assessments with intragastric pH
• Safety assessments with adverse event monitoring including subjective/objective symptoms, physical examination, vital signs, electrocardiogram, and laboratory test

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital, Clinical Trial Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 64 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy adults aged 19 to 65 years (not inclusive) at the time of signing the informed consent form (ICF).
• Body mass index (BMI) ≥ 17.5 and < 30.5 kg/m^2 with a body weight ≥ 45 kg at screening. Body mass index (kg/m^2) = weight (kg)/height (m)^2
• Confirmed as H. pylori negative
• A subject without any congenital or chronic disease within 3 years, and has no medical examination result as pathological symptoms or signs.
• A subject determined eligible for this study based on the screening test such as clinical laboratory tests (hematology test, chemistry test, urine test, virus/bacteria test, etc.), vital signs, and electrocardiogram.
• A subject who is fully informed of the purpose and content of the study and agrees to participate in the study on its own will and signs the consent form approved by the Institutional Review Board (IRB) of the Seoul National University Hospital, prior to participate in the study.
• A subject who has the ability and willingness to participate throughout the whole study period.

Exclusion Criteria:

• A subject with clinically significant blood, renal, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, hepatic, psychical, neurologic, or immunologic diseases (except for simple dental past history such as tartar, impacted tooth, or wisdom tooth) or evidence.
• A subject with a history of gastrointestinal disorders (esophageal diseases such as esophageal achalasia or esophageal stricture, Crohn's disease) or surgery (except for simple appendectomy, herniotomy, and tooth extraction surgery) that may affect the absorption of drugs.
• A subject with the *17 allele of CYP2C19 (Ultrarapid metabolizer).
• A subject with AST and ALT levels exceeding 3 times of the upper limit of the reference range in the screening test.
• A subject with a history of excessive caffeine (> 5 units/day) or regular alcohol consumption exceeding 210 g/week within 6 months of screening test. (1 glass of beer (5%) (250 mL) = 10 g, 1 shot of soju (20%) (50 mL) = 8 g, 1 glass of wine (12%) (125 mL) = 12 g)
• A subject who participated in other clinical trial or bioequivalence study and administered the study medication within 6 months prior to the first administration of the investigational product of this study.
• A subject with significant alcohol or drug abuse within a year of screening test.
• A subject who administered drugs that significantly induce or inhibit drug metabolizing enzymes within 30 days prior to the first administration of the investigational product of this study.
• A subject who smoked cigarettes more than 20 per day within 6 months of screening test.
• A subject who administered prescribed drug or over-the-counter drug within 10 days prior to the first administration of the investigational product of this study.
• A subject who has donated whole blood within 2 months or those who donated the component blood within 1 month prior to the first administration of the investigational product of this study.
• A subject who has hypersensitivity to the investigational product of this study, benzimidazoles, penicillin and macrolide and its related medical history.
• A subject with rare genetic problems such as fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency.
• Pregnant or nursing women
• A subject who cannot use reliable contraception during the entire period of the clinical trial (e.g, condom use, intrauterine device, tubal ligation, cervical cap, contraceptive diaphragm, etc.).
• A subject who is judged by the investigator to be ineligible to participate in the test.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Tegoprazan 50 mg; Oral administration of Tegoprazan 50 mg tablet once a day	Drug: Tegoprazan 50 mg; Tegoprazan 50 mg tablet; Other Names: K-CAB
ACTIVE_COMPARATOR: EAPA115; Oral administration of EAPA115 once a day	Drug: EAPA115; EAPA115
ACTIVE_COMPARATOR: RAPA115; Oral administration of RAPA115 once a day	Drug: RAPA115; RAPA115

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacodynamic Evaluation	The ratio of duration(Duration %) with pH ≥ 4 over 24 hours	Pre-dose(0 hour) up to 24 hours after Investigational product administration in each period
Pharmacodynamic Evaluation	The ratio of duration(Duration %) with pH ≥ 6 over 24 hours	Pre-dose(0 hour) up to 24 hours after Investigational product administration in each period
Pharmacodynamic Evaluation	Median pH	Pre-dose(0 hour) up to 24 hours after Investigational product administration in each period
Pharmacodynamic Evaluation	Mean pH	Pre-dose(0 hour) up to 24 hours after Investigational product administration in each period
Pharmacodynamic Evaluation	Baseline pH and changes in pH after the administration of investigational products (change of duration %, change of mean pH, change of median pH)	Pre-dose(0 hour) up to 24 hours after Investigational product administration in each period
Pharmacodynamic Evaluation	The ratio of duration(Duration %) with pH ≥ 4 during nocturnal period* (*12 hours after administration of investigational product)	Pre-dose(0 hour) up to 12 hours after Investigational product administration in each period
Pharmacodynamic Evaluation	The ratio of duration(Duration %) with pH ≥ 6 during nocturnal period* (*12 hours after administration of investigational product)	Pre-dose(0 hour) up to 12 hours after Investigational product administration in each period

Collaborators and Investigators

• Sponsor: HK inno.N Corporation

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 14, 2020
• Primary Completion (ACTUAL): July 29, 2020
• Study Completion (ACTUAL): August 3, 2020

Study Registration Dates

• First Submitted: January 9, 2020
• First Submitted That Met QC Criteria: January 13, 2020
• First Posted (ACTUAL): January 18, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 1, 2020
• Last Update Submitted That Met QC Criteria: November 29, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: CJ_APA_115

Drug and device information, study documents

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