A Study to Evaluate Safety, Tolerability, and PD of Tegop... | NCT03378284

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

NCT03378284

Sponsor

HK inno.N Corporation

Status

Completed

Last Update Posted

Mar 30, 2018Actual

Enrollment

16Actual

Phase

Phase 1

Conditions

Pharmacodynamics
Healthy Male Volunteers

Interventions

Tegoprazan
Revaprazan

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 10, 2017Actual

Primary Completion Date

Dec 23, 2017Actual

Completion Date

Jan 16, 2018Actual

First Submitted Date

Dec 13, 2017

First Submission Date that Met QC Criteria

Dec 18, 2017

First Posted Date

Dec 19, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 28, 2018

Last Update Posted Date

Mar 30, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Tegoprazan	Drug	Tegoprazan QD for 7 days	Tegoprazan(Test drug)
Revaprazan

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Gastric pH	Gastric pH	up to 7 days
Serum gastrin concentration	Serum gastrin concentration	up to 9 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
In Jin Jang, MD, PhD	Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000631239	tegoprazan
C108798	YH 1885

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided