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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DWP14012 After Oral Administration in Healthy Male Volunteers

NCT ID: NCT02757144

Last Updated: 2017-04-25

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

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-02-28

Brief Summary

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This is a dose block-randomized, double-blind, placebo- and active-controlled, single and multiple dosing, dose-escalation clinical phase 1 trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of DWP14012 after oral administration in healthy male volunteers.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort 1: DWP14012 Amg

DWP14012 Amg, tablets, orally, single dose administration

Group Type EXPERIMENTAL

DWP14012

Intervention Type DRUG

DWP14012 tablets

Placebo

Intervention Type DRUG

DWP14012 placebo-matching tablets, Active control placebo-matching tablets

Cohort 2: DWP14012 Bmg

DWP14012 Bmg, tablets, orally, single dose administration

Group Type EXPERIMENTAL

DWP14012

Intervention Type DRUG

DWP14012 tablets

Placebo

Intervention Type DRUG

DWP14012 placebo-matching tablets, Active control placebo-matching tablets

Cohort 3: DWP14012 Cmg

DWP14012 Cmg, tablets, orally, single dose administration

Group Type EXPERIMENTAL

DWP14012

Intervention Type DRUG

DWP14012 tablets

Placebo

Intervention Type DRUG

DWP14012 placebo-matching tablets, Active control placebo-matching tablets

Cohort 4: DWP14012 Dmg

DWP14012 Dmg, tablets, orally, single dose administration

Group Type EXPERIMENTAL

DWP14012

Intervention Type DRUG

DWP14012 tablets

Placebo

Intervention Type DRUG

DWP14012 placebo-matching tablets, Active control placebo-matching tablets

Cohort 5: DWP14012 Emg

DWP14012 Emg, tablets, orally, single dose administration

Group Type EXPERIMENTAL

DWP14012

Intervention Type DRUG

DWP14012 tablets

Placebo

Intervention Type DRUG

DWP14012 placebo-matching tablets, Active control placebo-matching tablets

Cohort 6: DWP14012 Fmg

DWP14012 Emg, tablets, orally, single dose administration

Group Type EXPERIMENTAL

DWP14012

Intervention Type DRUG

DWP14012 tablets

Placebo

Intervention Type DRUG

DWP14012 placebo-matching tablets, Active control placebo-matching tablets

Cohort 1-6: Placebo

DWP14012 placebo-matching tablets, Active-control placebo-matching tablets, orally, single dose administration

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

DWP14012 placebo-matching tablets, Active control placebo-matching tablets

Cohort 1-6: Esomeprazole

Nexium® tablets, orally, single dose administration

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

DWP14012 placebo-matching tablets, Active control placebo-matching tablets

Esomeprazole

Intervention Type DRUG

Nexium®

Cohort 7: DWP14012 Amg

DWP14012 Amg, tablets, orally, repeated dose administration(for 7days)

Group Type EXPERIMENTAL

DWP14012

Intervention Type DRUG

DWP14012 tablets

Placebo

Intervention Type DRUG

DWP14012 placebo-matching tablets, Active control placebo-matching tablets

Cohort 8: DWP14012 Bmg

DWP14012 Bmg, tablets, orally, repeated dose administration(for 7days)

Group Type EXPERIMENTAL

DWP14012

Intervention Type DRUG

DWP14012 tablets

Placebo

Intervention Type DRUG

DWP14012 placebo-matching tablets, Active control placebo-matching tablets

Cohort 9: DWP14012 Cmg

DWP14012 Cmg, tablets, orally, repeated dose administration(for 7days)

Group Type EXPERIMENTAL

DWP14012

Intervention Type DRUG

DWP14012 tablets

Placebo

Intervention Type DRUG

DWP14012 placebo-matching tablets, Active control placebo-matching tablets

Cohort 7-10: Placebo

DWP14012 placebo-matching tablets, Active-control placebo-matching tablets, orally, repeated dose administration(for 7days)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

DWP14012 placebo-matching tablets, Active control placebo-matching tablets

Cohort 7-10: Esomeprazole

Nexium®, orally, repeated dose administration(for 7days)

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

DWP14012 placebo-matching tablets, Active control placebo-matching tablets

Esomeprazole

Intervention Type DRUG

Nexium®

Cohort 9: DWP14012 Dmg

DWP14012 Dmg, tablets, orally, repeated dose administration(for 7days)

Group Type EXPERIMENTAL

DWP14012

Intervention Type DRUG

DWP14012 tablets

Placebo

Intervention Type DRUG

DWP14012 placebo-matching tablets, Active control placebo-matching tablets

Interventions

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DWP14012

DWP14012 tablets

Intervention Type DRUG

Placebo

DWP14012 placebo-matching tablets, Active control placebo-matching tablets

Intervention Type DRUG

Esomeprazole

Nexium®

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy adult males aged between 19 and 50 at screening
* Those whose weight is between 55 and 90 kg and BMI is between 18.0 and 27.0
* Those who are adequate to be subjects in this study upon judgment of the investigator after physical examination, clinical laboratory test, examination by interview, etc

Exclusion Criteria

* Those who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history
* Those who have gastrointestinal diseases or past history of gastrointestinal diseases (gastrointestinal ulcer, gastritis, gastrospasm, gastroesophageal reflux, Crohn's disease etc.) that may affect safety and pharmacokinetic/pharmacodynamic evaluation of study drug, and those who have past history of gastrointestinal surgery (however, except simple appendectomy and herniotomy)
* Those who have been Helicobacter pylori positive
* Those whose plasma AST (SGOT) and ALT (SGPT) exceed 1.5 times to the upper limit of the normal range in screening including additional examinations prior to randomization
* Those who have anatomical disability in insertion and maintenance of pH meter catheter
Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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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DW_DWP14012001

Identifier Type: -

Identifier Source: org_study_id

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