A Phase 1 Study of Tegoprazan on Healthy Male Volunteers

Phase 1

• Conditions: Pharmacodynamics; Healthy Male Volunteers; Pharmacokinetics
• Interventions: Drug: Tegoprazan (C1); Drug: Tegoprazan (C2); Drug: Tegoprazan (C3); Drug: Esomeprazole (C2)

• Registration Number: NCT03530228
• Lead Sponsor: HK inno.N Corporation

Brief Summary

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

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 Timeline

• Status Verified: 2018-05
• Study Start: 2018-05
• Study First Submitted: 2018-05-08
• Study First Submitted QC: 2018-05-18
• Last Update Submitted: 2018-05-18
• Study First Posted: 2018-05-21
• Last Update Posted: 2018-05-21
• Primary Completion: 2018-08
• Study Completion: 2018-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment B: Tegoprazan (C1)	Tegoprazan (C1)	Tegoprazan QD, oral administration
Group 1: Tegoprazan (C2)	Tegoprazan (C2)	Tegoprazan QD, oral administration, for 7 days
Tegoprazan (C3)	Tegoprazan (C3)	Tegoprazan QD, oral administration
Group 2: Tegoprazan (C2)	Tegoprazan (C2)	Tegoprazan QD, oral administration, for 7 days
Treatment A: Tegoprazan (C1)	Tegoprazan (C1)	Tegoprazan QD, oral administration
Group 3: Esomeprazole (C2)	Esomeprazole (C2)	Esomeprazole QD, oral administration, for 7 days

Primary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of