NCT04490434

Brief Summary

drug-drug interaction between DWP14012 and three different kinds of NSAIDs

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2020

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

June 19, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 29, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

July 29, 2020

Status Verified

July 1, 2020

Enrollment Period

2 months

First QC Date

April 24, 2020

Last Update Submit

July 27, 2020

Conditions

Healthy Male Volunteers

Outcome Measures

Primary Outcomes (12)

  • Arm A, Cmax,ss of Celecoxib

    Maximum measured plasma concentration at steady-state

    Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)

  • Arm A, AUCτ,ss of Celecoxib

    Area under the plasma concentration-time curve

    Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)

  • Arm B, Cmax,ss of DWP14012

    Maximum measured plasma concentration at steady-state

    Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)

  • Arm B, AUCτ,ss of DWP14012

    Area under the plasma concentration-time curve

    Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)

  • Arm C, Cmax,ss of Naproxen

    Maximum measured plasma concentration at steady-state

    Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)

  • Arm C, AUCτ,ss of Naproxen

    Area under the plasma concentration-time curve

    Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)

  • Arm D, Cmax,ss of DWP14012

    Maximum measured plasma concentration at steady-state

    Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)

  • Arm D, AUCτ,ss of DWP14012

    Area under the plasma concentration-time curve

    Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)

  • Arm E, Cmax,ss of Meloxicam

    Maximum measured plasma concentration at steady-state

    Day 7,(0 hours (pre-dose), 1~72 hours) / Day 16,(0 hours (pre-dose), 1~72 hours)

  • Arm E, AUCτ,ss of Meloxicam

    Area under the plasma concentration-time curve

    Day 7,(0 hours (pre-dose), 1~72 hours) / Day 16,(0 hours (pre-dose), 1~72 hours)

  • Arm D, Cmax,ss of DWP14012

    Maximum measured plasma concentration at steady-state

    Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 13,(0 hours (pre-dose), 0.5~48 hours)

  • Arm D, AUCτ,ss of DWP14012

    Area under the plasma concentration-time curve

    Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 13,(0 hours (pre-dose), 0.5~48 hours)

Study Arms (6)

Cohort 1, A (DWP14012/Celecoxib)

EXPERIMENTAL

Patients treated with DWP14012, Celecoxib will be enrolled. DDI will be evaluated.

Drug: DWP14012Drug: Celecoxib

Cohort 1, B (DWP14012/Celecoxib)

EXPERIMENTAL

Patients treated with DWP14012, Celecoxib will be enrolled. DDI will be evaluated.

Drug: DWP14012Drug: Celecoxib

Cohort 2, C (DWP14012/Naproxen)

EXPERIMENTAL

Patients treated with DWP14012, Naproxen will be enrolled. DDI will be evaluated.

Drug: DWP14012Drug: Naproxen

Cohort 2, D (DWP14012/Naproxen)

EXPERIMENTAL

Patients treated with DWP14012, Naproxen will be enrolled. DDI will be evaluated.

Drug: DWP14012Drug: Naproxen

Cohort 3, E (DWP14012/Meloxicam)

EXPERIMENTAL

Patients treated with DWP14012, Meloxicam will be enrolled. DDI will be evaluated.

Drug: DWP14012Drug: Meloxicam

Cohort 3, F (DWP14012/Meloxicam)

EXPERIMENTAL

Patients treated with DWP14012, Meloxicam will be enrolled. DDI will be evaluated.

Drug: DWP14012Drug: Meloxicam

Interventions

DWP14012DRUG

DWP14012 40mg, bid

Cohort 1, A (DWP14012/Celecoxib)Cohort 1, B (DWP14012/Celecoxib)Cohort 2, C (DWP14012/Naproxen)Cohort 2, D (DWP14012/Naproxen)Cohort 3, E (DWP14012/Meloxicam)Cohort 3, F (DWP14012/Meloxicam)
CelecoxibDRUG

Celecoxib 200mg, bid

Cohort 1, A (DWP14012/Celecoxib)Cohort 1, B (DWP14012/Celecoxib)
NaproxenDRUG

Naproxen 500mg, bid

Cohort 2, C (DWP14012/Naproxen)Cohort 2, D (DWP14012/Naproxen)
MeloxicamDRUG

Meloxicam 15mg, qd

Cohort 3, E (DWP14012/Meloxicam)Cohort 3, F (DWP14012/Meloxicam)

Eligibility Criteria

Age19 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (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 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
  • Subjects who have participated and taken investigational drug in any other clinical trial (including bioequivalence study) within six months prior to study drug administration
  • Subjects who have donated a unit of whole blood within two months or blood components within one month prior to study drug administration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Related Publications (1)

  • Won H, Kim E, Chae J, Lee H, Cho JY, Jang IJ, Chung JY, Kim MG, Lee S. Pharmacokinetic interactions between fexuprazan, a potassium-competitive acid blocker, and nonsteroidal anti-inflammatory drugs in healthy males. Clin Transl Sci. 2024 May;17(5):e13798. doi: 10.1111/cts.13798.

    PMID: 38700290DERIVED

MeSH Terms

Interventions

fexuprazanCelecoxibNaproxenMeloxicam

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNaphthaleneacetic AcidsNaphthalenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsThiazinesThiazoles

Study Officials

  • Jang In-Jin, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jang In-Jin, MD, PhD

CONTACT

+82-2-2072-1910ijjang@snu.ac.kr

Study Design

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

Study Record Dates

First Submitted

April 24, 2020

First Posted

July 29, 2020

Study Start

June 19, 2020

Primary Completion

August 31, 2020

Study Completion

November 30, 2020

Last Updated

July 29, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)