Food-Effect on PK and PD of Single Oral Dose of Tegoprazan in Healthy Male Subjects

A Randomized, Open-label, Single-dose Phase 1 Clinical Trial to Compare the Effect of Timing of Food on the Pharmacokinetics and Pharmacodynamics of K-CAB (Tegoprazan) in Healthy Male Subjects

This study aims to evaluate the food-effect of tegoprazan 50mg on the pharmacokinetics and pharmacodynamics in healthy H. pylori negative male volunteers

Study Overview

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

Detailed Description

Primary Outcome Measure:

1. AUClast and Cmax of tegaprazan
2. Gastric pH

• Study Type: Interventional
• Enrollment (Actual): 12
• 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 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy adult males aged ≥ 19 years and ≤ 50 years
• Body weight of ≥ 55.0 kg and ≤ 90.0 kg, with body mass index (BMI) of ≥ 18.0 kg/m2 and ≤ 27.0 kg/m2 at the time of screening
• Helicobacter pylori negative

Exclusion Criteria:

• Presence or history of clinically significant diseases
• Presence or history of gastrointestinal disorder (gastric ulcer, GERD, Crohn's disease, etc.)
• Hypersensitivity to drugs containing study drug or proton pump inhibitor and other drugs (aspirin, antibiotics, etc.) or history of clinically significant hypersensitivity
• Serologic test positive
• Abnormal obstacle to insertion and maintenance of pH meter catheter
• History of drug abuse
• Excessive caffeine intake or persistent alcohol intake
• Not use of a medically acceptable method of contraception

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 50mg under fasting condition; Treatment A: single oral administration of Tegoprazan 50mg tablet under fasting condition once a day	Drug: Tegoprazan 50mg; K-CAB; Other Names: Tegoprazan 50mg tablet
EXPERIMENTAL: Tegoprazan 50mg before the meal; Treatment B: single oral administration of Tegoprazan 50mg tablet before the meal once a day	Drug: Tegoprazan 50mg; K-CAB; Other Names: Tegoprazan 50mg tablet
EXPERIMENTAL: Tegoprazan 50mg after the meal; Treatment C: single oral administration of Tegoprazan 50mg tablet after the meal once a day	Drug: Tegoprazan 50mg; K-CAB; Other Names: Tegoprazan 50mg tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUClast of tegaprazan	Area under the plasma concentration versus time curve of tegoprazan	Pre-dose(0 hour) and up to 48 hours in each period
Cmax of tegaprazan	Peak Plasma Concentration of tegoprazan	Pre-dose(0 hour) and up to 48 hours in each period
Gastric pH	Gastric pH	Pre-dose(0 hour) up to 24 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): March 27, 2019
• Primary Completion (ACTUAL): April 26, 2019
• Study Completion (ACTUAL): June 25, 2019

Study Registration Dates

• First Submitted: February 28, 2019
• First Submitted That Met QC Criteria: March 3, 2019
• First Posted (ACTUAL): March 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 22, 2019
• Last Update Submitted That Met QC Criteria: August 20, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: CJ_APA_112

Drug and device information, study documents

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