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

D

Daewoong Pharmaceutical

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: Placebo
Drug: DWP14012
Drug: Esomeprazole

Study type

Interventional

Funder types

Industry

Identifiers

NCT02757144
DW_DWP14012001

Details and patient eligibility

About

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.

Enrollment

120 estimated patients

Sex

Male

Ages

19 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

120 participants in 14 patient groups, including a placebo group

Cohort 1: DWP14012 Amg
Experimental group
Description:
DWP14012 Amg, tablets, orally, single dose administration
Treatment:
Drug: DWP14012
Drug: Placebo
Cohort 2: DWP14012 Bmg
Experimental group
Description:
DWP14012 Bmg, tablets, orally, single dose administration
Treatment:
Drug: DWP14012
Drug: Placebo
Cohort 3: DWP14012 Cmg
Experimental group
Description:
DWP14012 Cmg, tablets, orally, single dose administration
Treatment:
Drug: DWP14012
Drug: Placebo
Cohort 4: DWP14012 Dmg
Experimental group
Description:
DWP14012 Dmg, tablets, orally, single dose administration
Treatment:
Drug: DWP14012
Drug: Placebo
Cohort 5: DWP14012 Emg
Experimental group
Description:
DWP14012 Emg, tablets, orally, single dose administration
Treatment:
Drug: DWP14012
Drug: Placebo
Cohort 6: DWP14012 Fmg
Experimental group
Description:
DWP14012 Emg, tablets, orally, single dose administration
Treatment:
Drug: DWP14012
Drug: Placebo
Cohort 1-6: Placebo
Placebo Comparator group
Description:
DWP14012 placebo-matching tablets, Active-control placebo-matching tablets, orally, single dose administration
Treatment:
Drug: Placebo
Cohort 1-6: Esomeprazole
Active Comparator group
Description:
Nexium® tablets, orally, single dose administration
Treatment:
Drug: Esomeprazole
Drug: Placebo
Cohort 7: DWP14012 Amg
Experimental group
Description:
DWP14012 Amg, tablets, orally, repeated dose administration(for 7days)
Treatment:
Drug: DWP14012
Drug: Placebo
Cohort 8: DWP14012 Bmg
Experimental group
Description:
DWP14012 Bmg, tablets, orally, repeated dose administration(for 7days)
Treatment:
Drug: DWP14012
Drug: Placebo
Cohort 9: DWP14012 Cmg
Experimental group
Description:
DWP14012 Cmg, tablets, orally, repeated dose administration(for 7days)
Treatment:
Drug: DWP14012
Drug: Placebo
Cohort 7-10: Placebo
Placebo Comparator group
Description:
DWP14012 placebo-matching tablets, Active-control placebo-matching tablets, orally, repeated dose administration(for 7days)
Treatment:
Drug: Placebo
Cohort 7-10: Esomeprazole
Active Comparator group
Description:
Nexium®, orally, repeated dose administration(for 7days)
Treatment:
Drug: Esomeprazole
Drug: Placebo
Cohort 9: DWP14012 Dmg
Experimental group
Description:
DWP14012 Dmg, tablets, orally, repeated dose administration(for 7days)
Treatment:
Drug: DWP14012
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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