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

NCT04231136 | Completed Phase 1

• 1 other identifier: CJ_APA_115
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (3)

Tegoprazan 50 mg

EXPERIMENTAL

Oral administration of Tegoprazan 50 mg tablet once a day

Drug: Tegoprazan 50 mg

EAPA115

ACTIVE COMPARATOR

Oral administration of EAPA115 once a day

Drug: EAPA115

RAPA115

ACTIVE COMPARATOR

Oral administration of RAPA115 once a day

Drug: RAPA115

Interventions

Tegoprazan 50 mg DRUG

Tegoprazan 50 mg tablet

Also known as: K-CAB

Tegoprazan 50 mg

EAPA115 DRUG

EAPA115

EAPA115

RAPA115 DRUG

RAPA115

RAPA115

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• HK inno.N Corporation: lead

Study Sites (1)

Seoul National University Hospital, Clinical Trial Center

Seoul, South Korea

Location

MeSH Terms

Interventions

tegoprazan

Study Officials

• In-Jin Jang, MD, PhD

  Seoul National University Hospital, Dept. of Clinical Pharmacology

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: January 18, 2020
• Study Start: January 14, 2020
• Primary Completion: July 29, 2020
• Study Completion: August 3, 2020
• Last Updated: December 1, 2020

Record last verified: 2020-01

Locations

KR (1)