A Study to Evaluate Safety, Tolerability, and PD of Tegoprazan on Healthy Male Volunteers

A Randomized, Open-label, Active-controlled, Multiple Dose Phase 1 Clinical Trial to Evaluate Safety, Tolerability, and Pharmacodynamics of Tegoprazan After Oral Administration in Healthy Male Volunteers

A randomized, open-label, active-controlled, multiple dose phase 1 clinical trial to evaluate safety, tolerability, and pharmacodynamics of tegoprazan after oral administration in healthy male volunteers

Study Overview

• Status: Completed
• Conditions: Pharmacodynamics; Healthy Male Volunteers
• Intervention / Treatment: Drug: Tegoprazan; Drug: Revaprazan

Detailed Description

• To compare the pharmacodynamics of multiple oral dose of tegoprazan versus the pharmacodynamics of multiple oral dose of comparator drug in healthy male volunteers.
• To evaluate the safety and tolerability of multiple oral dose of tegoprazan in healthy male volunteers.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• 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

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: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tegoprazan(Test drug); Tegoprazan drug QD for 7 days	Drug: Tegoprazan; Tegoprazan QD for 7 days
Active Comparator: Active comparator drug; Active comparator drug QD for 7 days	Drug: Revaprazan; Revaprazan QD for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastric pH	Gastric pH	up to 7 days
Serum gastrin concentration	Serum gastrin concentration	up to 9 days

Collaborators and Investigators

• Sponsor: HK inno.N Corporation
• Investigators: Principal Investigator: In Jin Jang, MD, PhD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2017
• Primary Completion (Actual): December 23, 2017
• Study Completion (Actual): January 16, 2018

Study Registration Dates

• First Submitted: December 13, 2017
• First Submitted That Met QC Criteria: December 18, 2017
• First Posted (Actual): December 19, 2017

Study Record Updates

• Last Update Posted (Actual): March 30, 2018
• Last Update Submitted That Met QC Criteria: March 28, 2018
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: CJ_APA_108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

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