A Phase 1 Study of Tegoprazan on Healthy Male Volunteers

A Randomized, Open-label, Active-controlled, Single/Multiple-dose Phase 1 Clinical Trial to Evaluate Pharmacokinetics/Pharmacodynamics and Safety/Tolerability of Tegoprazan After Oral Administration in Healthy Male Subjects

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

Study Overview

• Status: Unknown
• Conditions: Pharmacokinetics; Pharmacodynamics; Healthy Male Volunteers
• Intervention / Treatment: Drug: Tegoprazan (C1); Drug: Tegoprazan (C1); Drug: Treatment C: Tegoprazan (C1); Drug: Tegoprazan (C2); Drug: Tegoprazan (C2); Drug: Esomeprazole (C2); Drug: Tegoprazan (C3)

Detailed Description

• To evaluate the pharmacokinetics and pharmacodynamics of single oral dose of tegoprazan between dose groups in healthy H. pylori negative males.
• To evaluate the pharmacokinetics and pharmacodynamics of multiple oral dose of tegoprazan under the fed state in healthy H. pylori negative males.
• To evaluate the pharmacokinetics and pharmacodynamics of single oral dose of tegoprazan in healthy H. pylori positive males.

• Study Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: In Jin Jang, MD, PhD; Phone Number: 82-2-2072-1666; Email: ijjang@snu.ac.kr
• Study Contact Backup: Name: Mu Seong Ban, MD; Phone Number: 82-2-2072-1666; Email: ban2699@snu.ac.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul National University Hospital
    • Contact: In Jin Jang, MD, PhD; Phone Number: 82-2-2072-1666; Email: ijjang@snu.ac.kr
    • Contact: Mu Seong Ban, MD; Phone Number: 82-2-2072-1666; Email: ban2699@snu.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 48 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: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment A: Tegoprazan (C1); Tegoprazan QD, oral administration	Drug: Tegoprazan (C1); Tegoprazan QD, oral administration. Treatment A; Drug: Tegoprazan (C1); Tegoprazan QD, oral administration. Treatment B
Experimental: Treatment B: Tegoprazan (C1); Tegoprazan QD, oral administration	Drug: Tegoprazan (C1); Tegoprazan QD, oral administration. Treatment A; Drug: Tegoprazan (C1); Tegoprazan QD, oral administration. Treatment B
Experimental: Treatment C: Tegoprazan (C1); Tegoprazan BID, oral administration	Drug: Treatment C: Tegoprazan (C1); Tegoprazan BID, oral administration
Experimental: Group 1: Tegoprazan (C2); Tegoprazan QD, oral administration, for 7 days	Drug: Tegoprazan (C2); Tegoprazan QD, oral administration, for 7 days. Group 1; Drug: Tegoprazan (C2); Tegoprazan QD, oral administration, for 7 days. Group 2
Experimental: Group 2: Tegoprazan (C2); Tegoprazan QD, oral administration, for 7 days	Drug: Tegoprazan (C2); Tegoprazan QD, oral administration, for 7 days. Group 1; Drug: Tegoprazan (C2); Tegoprazan QD, oral administration, for 7 days. Group 2
Active Comparator: Group 3: Esomeprazole (C2); Esomeprazole QD, oral administration, for 7 days	Drug: Esomeprazole (C2); Esomeprazole QD, oral administration, for 7 days. Group 3
Experimental: Tegoprazan (C3); Tegoprazan QD, oral administration	Drug: Tegoprazan (C3); Tegoprazan QD, oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC(0-24h) of tegoprazan	Area Under the Curve(0-24h) of tegoprazan	up to 7 days
Cmax of tegoprazan	Maximum Plasma Concentration of tegoprazan	up to 7 days
Gastric pH	Gastric pH	up to 7 days
Serum gastrin concentration	Serum gastrin concentration	up to 7 days

Collaborators and Investigators

• Sponsor: HK inno.N Corporation

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2018
• Primary Completion (Anticipated): August 1, 2018
• Study Completion (Anticipated): August 1, 2018

Study Registration Dates

• First Submitted: May 8, 2018
• First Submitted That Met QC Criteria: May 18, 2018
• First Posted (Actual): May 21, 2018

Study Record Updates

• Last Update Posted (Actual): May 21, 2018
• Last Update Submitted That Met QC Criteria: May 18, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Esomeprazole
• Other Study ID Numbers: CJ_APA_109

Drug and device information, study documents

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