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

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

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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