NCT03378284

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2017

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 10, 2017

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 13, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 19, 2017

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2017

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2018

Completed
Last Updated

March 30, 2018

Status Verified

December 1, 2017

Enrollment Period

13 days

First QC Date

December 13, 2017

Last Update Submit

March 28, 2018

Conditions

PharmacodynamicsHealthy Male Volunteers

Outcome Measures

Primary Outcomes (2)

  • Gastric pH

    Gastric pH

    up to 7 days

  • Serum gastrin concentration

    Serum gastrin concentration

    up to 9 days

Study Arms (2)

Tegoprazan(Test drug)

EXPERIMENTAL

Tegoprazan drug QD for 7 days

Drug: Tegoprazan

Active comparator drug

ACTIVE COMPARATOR

Active comparator drug QD for 7 days

Drug: Revaprazan

Interventions

TegoprazanDRUG

Tegoprazan QD for 7 days

Tegoprazan(Test drug)
RevaprazanDRUG

Revaprazan QD for 7 days

Active comparator drug

Eligibility Criteria

Age19 Years - 50 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

tegoprazanYH 1885

Study Officials

  • In Jin Jang, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2017

First Posted

December 19, 2017

Study Start

December 10, 2017

Primary Completion

December 23, 2017

Study Completion

January 16, 2018

Last Updated

March 30, 2018

Record last verified: 2017-12

Locations

KR(1)