NCT04328766

Brief Summary

An open-label, multiple-dose clinical trial to evaluate the safety/tolerability and pharmacokinetic interaction between DWP14012 and DWC202005 in healthy volunteers

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2020

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

March 24, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 31, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

September 6, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2020

Completed
Last Updated

August 16, 2021

Status Verified

August 1, 2021

Enrollment Period

3 months

First QC Date

March 24, 2020

Last Update Submit

August 13, 2021

Conditions

Drug-drug Interaction

Outcome Measures

Primary Outcomes (3)

  • Area under the plasma drug concentration-time curve

    AUClast of DWC202005

    upto 48 hours postdose

  • Peak Plasma Concentration (Cmax)

    Cmax of DWC202005

    upto 48 hours postdose

  • Incidence of Treatment-Emergent Adverse Events

    up to 19 days

Study Arms (3)

DWP14012 Cohort A

EXPERIMENTAL
Drug: DWC202005, alone

DWP14012 Cohort B

EXPERIMENTAL
Drug: DWP14012 + DWC202005

DWP14012 Cohort C

EXPERIMENTAL
Drug: DWP14012 + DWC202005, after multiple doses of DWP14012

Interventions

DWC202005, aloneDRUG

DWC202005, as a single dose

DWP14012 Cohort A
DWP14012 + DWC202005DRUG

DWP14012 and DWC202005, as a single dose

DWP14012 Cohort B
DWP14012 + DWC202005, after multiple doses of DWP14012DRUG

DWP14012 and DWC202005, after multiple oral doses of DWP14012 once daily for 12 days

DWP14012 Cohort C

Eligibility Criteria

Age19 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adults aged 19 to 50 years with BMI between 18.5 kg/m2 and 30.0 kg/m2
  • Capable of understanding provided information and complying with protocol requirements
  • Provide written informed consent to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nucleus Network (QPharm)

Queensland, Queensland, 78, Australia

Location

MeSH Terms

Interventions

Single Personfexuprazan

Intervention Hierarchy (Ancestors)

Marital StatusFamily CharacteristicsDemographyPopulation CharacteristicsSocioeconomic Factors

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2020

First Posted

March 31, 2020

Study Start

September 6, 2020

Primary Completion

November 21, 2020

Study Completion

November 21, 2020

Last Updated

August 16, 2021

Record last verified: 2021-08

Locations

AU(1)