A Phase 1 Study of Tegoprazan on Healthy Male Volunteers

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Pharmacodynamics, Pharmacokinetics, Healthy Male Volunteers

Intervention / Treatment
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* Drug: Tegoprazan (C1)
* Drug: Tegoprazan (C1)
* Drug: Treatment C: Tegoprazan (C1)
* Drug: Tegoprazan (C2)
* Drug: Tegoprazan (C2)
* Drug: Esomeprazole (C2)
* Drug: Tegoprazan (C3)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Cohort 1: crossover Cohort 2: parallel Cohort 3: single group
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |