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

NCT ID: NCT03378284

Last Updated: 2018-03-30

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-10

Study Completion Date

2018-01-16

Brief Summary

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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

Detailed Description

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* 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.

Conditions

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Pharmacodynamics Healthy Male Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Tegoprazan(Test drug)

Tegoprazan drug QD for 7 days

Group Type EXPERIMENTAL

Tegoprazan

Intervention Type DRUG

Tegoprazan QD for 7 days

Active comparator drug

Active comparator drug QD for 7 days

Group Type ACTIVE_COMPARATOR

Revaprazan

Intervention Type DRUG

Revaprazan QD for 7 days

Interventions

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Tegoprazan

Tegoprazan QD for 7 days

Intervention Type DRUG

Revaprazan

Revaprazan QD for 7 days

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

Sponsors

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HK inno.N Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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In Jin Jang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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CJ_APA_108

Identifier Type: -

Identifier Source: org_study_id