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

Daewoong Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: DWP14012; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03574415

DW_DWP14012004

Details and patient eligibility

About

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

Enrollment: 80 patients

Sex: All

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 8 patient groups, including a placebo group

Japanese_DWP14012 Amg

Experimental group

Description:

DWP14012 Amg, tablets, orally, single and multiple administration

Treatment:

Drug: Placebo

Drug: DWP14012

Japanese_DWP14012 Bmg

Experimental group

Description:

DWP14012 Bmg, tablets, orally, single and multiple administration

Treatment:

Drug: Placebo

Drug: DWP14012

Japanese_DWP14012 Cmg

Experimental group

Description:

DWP14012 Cmg, tablets, orally, single and multiple administration

Treatment:

Drug: Placebo

Drug: DWP14012

Caucasian_DWP14012 Bmg

Experimental group

Description:

DWP14012 Bmg, tablets, orally, single and multiple administration

Treatment:

Drug: Placebo

Drug: DWP14012

Caucasian_DWP14012 Cmg

Experimental group

Description:

DWP14012 Cmg, tablets, orally, single and multiple administration

Treatment:

Drug: Placebo

Drug: DWP14012

Korean_DWP14012 Bmg

Experimental group

Description:

DWP14012 Bmg, tablets, orally, single and multiple administration

Treatment:

Drug: Placebo

Drug: DWP14012

Korean_DWP14012 Cmg

Experimental group

Description:

DWP14012 Cmg, tablets, orally, single and multiple administration

Treatment:

Drug: Placebo

Drug: DWP14012

Placebo

Placebo Comparator group

Description:

DWP14012 placebo-matching tablets

Treatment:

Drug: Placebo