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

Sponsor
Daewoong Pharmaceutical Co. LTD. (Industry)
Overall Status
Completed
CT.gov ID
NCT03574415
Collaborator
(none)
80
1
8
2.7
29.3

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
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
Actual Study Start Date :
Nov 1, 2018
Actual Primary Completion Date :
Jan 18, 2019
Actual Study Completion Date :
Jan 23, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Cmax [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]

    Maximum concentration of DWP14012

  2. Cmax,ss / Cmin,ss [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]

    Maximum / Minimum concentration of DWP14012 at steady state

  3. Tmax [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]

    Time of maximum concentration

  4. AUClast / AUCinf [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]

    Area under the plasma concentration-time curve

  5. T1/2 [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]

    Elimination half-life

  6. Percentage of total time that the intragastric pH was above 4 [Day 1]

    After single administration of the investigational products, 24hr gastric pH monitoring started.

  7. Percentage of total time that the intragastric pH was above 4 [Day 7]

    After single administration of the investigational products, 24hr gastric pH monitoring started.

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul National University Hospital Seoul Korea, Republic of

Sponsors and Collaborators

  • Daewoong Pharmaceutical Co. LTD.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier:
NCT03574415
Other Study ID Numbers:
  • DW_DWP14012004
First Posted:
Jul 2, 2018
Last Update Posted:
Jun 27, 2019
Last Verified:
Jun 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 27, 2019