Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DWP14012 After Oral Administration in Healthy Japanese, Caucasian and Korean

A Single-center, Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of DWP14012 in Healthy Japanese, Caucasian and Korean

To evaluate the safety and tolerability of single and multiple ascending oral doses of DWP14012 in healthy Japanese, Caucasian and Korean subjects

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: DWP14012; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy adult Caucasian or Japanese or Korean aged 19 to 50 (inclusive) years, at the time of screening.
• Subjects weighing between 50 kg and 90 kg with BMI between 18 and 27 kg/m2 (inclusive) at screening visit.

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Japanese_DWP14012 Amg; DWP14012 Amg, tablets, orally, single and multiple administration	Drug: DWP14012; DWP14012 tablets; Drug: Placebo; DWP14012 placebo-matching tablets
Experimental: Japanese_DWP14012 Bmg; DWP14012 Bmg, tablets, orally, single and multiple administration	Drug: DWP14012; DWP14012 tablets; Drug: Placebo; DWP14012 placebo-matching tablets
Experimental: Japanese_DWP14012 Cmg; DWP14012 Cmg, tablets, orally, single and multiple administration	Drug: DWP14012; DWP14012 tablets; Drug: Placebo; DWP14012 placebo-matching tablets
Experimental: Caucasian_DWP14012 Bmg; DWP14012 Bmg, tablets, orally, single and multiple administration	Drug: DWP14012; DWP14012 tablets; Drug: Placebo; DWP14012 placebo-matching tablets
Experimental: Caucasian_DWP14012 Cmg; DWP14012 Cmg, tablets, orally, single and multiple administration	Drug: DWP14012; DWP14012 tablets; Drug: Placebo; DWP14012 placebo-matching tablets
Experimental: Korean_DWP14012 Bmg; DWP14012 Bmg, tablets, orally, single and multiple administration	Drug: DWP14012; DWP14012 tablets; Drug: Placebo; DWP14012 placebo-matching tablets
Experimental: Korean_DWP14012 Cmg; DWP14012 Cmg, tablets, orally, single and multiple administration	Drug: DWP14012; DWP14012 tablets; Drug: Placebo; DWP14012 placebo-matching tablets
Placebo Comparator: Placebo; DWP14012 placebo-matching tablets	Drug: Placebo; DWP14012 placebo-matching tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Maximum concentration of DWP14012	1d pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 5d~10d pre-dose, 11d pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96h
Cmax,ss / Cmin,ss	Maximum / Minimum concentration of DWP14012 at steady state	1d pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 5d~10d pre-dose, 11d pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96h
Tmax	Time of maximum concentration	1d pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 5d~10d pre-dose, 11d pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96h
AUClast / AUCinf	Area under the plasma concentration-time curve	1d pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 5d~10d pre-dose, 11d pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96h
T1/2	Elimination half-life	1d pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 5d~10d pre-dose, 11d pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96h
Percentage of total time that the intragastric pH was above 4	After single administration of the investigational products, 24hr gastric pH monitoring started.	Day 1
Percentage of total time that the intragastric pH was above 4	After single administration of the investigational products, 24hr gastric pH monitoring started.	Day 7

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): January 18, 2019
• Study Completion (Actual): January 23, 2019

Study Registration Dates

• First Submitted: June 20, 2018
• First Submitted That Met QC Criteria: June 20, 2018
• First Posted (Actual): July 2, 2018

Study Record Updates

• Last Update Posted (Actual): June 27, 2019
• Last Update Submitted That Met QC Criteria: June 25, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: DW_DWP14012004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No