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

NCT03574415 | Completed Phase 1

• 1 other identifier: DW_DWP14012004
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (8)

Japanese_DWP14012 Amg

EXPERIMENTAL

DWP14012 Amg, tablets, orally, single and multiple administration

Drug: DWP14012; Drug: Placebo

Japanese_DWP14012 Bmg

EXPERIMENTAL

DWP14012 Bmg, tablets, orally, single and multiple administration

Drug: DWP14012; Drug: Placebo

Japanese_DWP14012 Cmg

EXPERIMENTAL

DWP14012 Cmg, tablets, orally, single and multiple administration

Drug: DWP14012; Drug: Placebo

Caucasian_DWP14012 Bmg

EXPERIMENTAL

DWP14012 Bmg, tablets, orally, single and multiple administration

Drug: DWP14012; Drug: Placebo

Caucasian_DWP14012 Cmg

EXPERIMENTAL

DWP14012 Cmg, tablets, orally, single and multiple administration

Drug: DWP14012; Drug: Placebo

Korean_DWP14012 Bmg

EXPERIMENTAL

DWP14012 Bmg, tablets, orally, single and multiple administration

Drug: DWP14012; Drug: Placebo

Korean_DWP14012 Cmg

EXPERIMENTAL

DWP14012 Cmg, tablets, orally, single and multiple administration

Drug: DWP14012; Drug: Placebo

Placebo

PLACEBO COMPARATOR

DWP14012 placebo-matching tablets

Drug: Placebo

Interventions

DWP14012 DRUG

DWP14012 tablets

Caucasian_DWP14012 Bmg; Caucasian_DWP14012 Cmg; Japanese_DWP14012 Amg; Japanese_DWP14012 Bmg; Japanese_DWP14012 Cmg; Korean_DWP14012 Bmg; Korean_DWP14012 Cmg

Placebo DRUG

DWP14012 placebo-matching tablets

Caucasian_DWP14012 Bmg; Caucasian_DWP14012 Cmg; Japanese_DWP14012 Amg; Japanese_DWP14012 Bmg; Japanese_DWP14012 Cmg; Korean_DWP14012 Bmg; Korean_DWP14012 Cmg; Placebo

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

fexuprazan

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2018
• First Posted: July 2, 2018
• Study Start: November 1, 2018
• Primary Completion: January 18, 2019
• Study Completion: January 23, 2019
• Last Updated: June 27, 2019

Record last verified: 2019-06

Locations

KR (1)