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

Daewoong Pharmaceutical Co. LTD.80 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Healthy Volunteers

Interventions

DWP14012DRUG

DWP14012 tablets

PlaceboDRUG

DWP14012 placebo-matching tablets

Eligibility

Sex: ALLMin age: 19 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea