A Phase 1 Study of Tegoprazan on Healthy Male Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-31

Study Completion Date

2018-08-31

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

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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.

Conditions

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Pharmacodynamics Pharmacokinetics Healthy Male Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Cohort 1: crossover Cohort 2: parallel Cohort 3: single group

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Treatment A: Tegoprazan (C1)

Tegoprazan QD, oral administration

Group Type EXPERIMENTAL

Tegoprazan (C1)

Intervention Type DRUG

Tegoprazan QD, oral administration. Treatment A

Treatment B: Tegoprazan (C1)

Tegoprazan QD, oral administration

Group Type EXPERIMENTAL

Tegoprazan (C1)

Intervention Type DRUG

Tegoprazan QD, oral administration. Treatment B

Treatment C: Tegoprazan (C1)

Tegoprazan BID, oral administration

Group Type EXPERIMENTAL

Treatment C: Tegoprazan (C1)

Intervention Type DRUG

Tegoprazan BID, oral administration

Group 1: Tegoprazan (C2)

Tegoprazan QD, oral administration, for 7 days

Group Type EXPERIMENTAL

Tegoprazan (C2)

Intervention Type DRUG

Tegoprazan QD, oral administration, for 7 days. Group 1

Group 2: Tegoprazan (C2)

Tegoprazan QD, oral administration, for 7 days

Group Type EXPERIMENTAL

Tegoprazan (C2)

Intervention Type DRUG

Tegoprazan QD, oral administration, for 7 days. Group 2

Group 3: Esomeprazole (C2)

Esomeprazole QD, oral administration, for 7 days

Group Type ACTIVE_COMPARATOR

Esomeprazole (C2)

Intervention Type DRUG

Esomeprazole QD, oral administration, for 7 days. Group 3

Tegoprazan (C3)

Tegoprazan QD, oral administration

Group Type EXPERIMENTAL

Tegoprazan (C3)

Intervention Type DRUG

Tegoprazan QD, oral administration

Interventions

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Tegoprazan (C1)

Tegoprazan QD, oral administration. Treatment A

Intervention Type DRUG

Tegoprazan (C1)

Tegoprazan QD, oral administration. Treatment B

Intervention Type DRUG

Treatment C: Tegoprazan (C1)

Tegoprazan BID, oral administration

Intervention Type DRUG

Tegoprazan (C2)

Tegoprazan QD, oral administration, for 7 days. Group 1

Intervention Type DRUG

Tegoprazan (C2)

Tegoprazan QD, oral administration, for 7 days. Group 2

Intervention Type DRUG

Esomeprazole (C2)

Esomeprazole QD, oral administration, for 7 days. Group 3

Intervention Type DRUG

Tegoprazan (C3)

Tegoprazan QD, oral administration

Intervention Type DRUG

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

Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes