NCT05699070

Brief Summary

An open-label phase 1 study to evaluate pharmacokinetic/pharmacodynamic drug-drug interactions and safety/tolerability of DWC202211 and DWC202212 compared to coadministration in healthy

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
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2023

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

January 10, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 26, 2023

Completed
20 days until next milestone

Study Start

First participant enrolled

February 15, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

April 4, 2023

Status Verified

January 1, 2023

Enrollment Period

2 months

First QC Date

January 10, 2023

Last Update Submit

April 3, 2023

Conditions

Drug-drug Interaction

Outcome Measures

Primary Outcomes (2)

  • Cmax

    up to 27 days

  • AUClast

    up to 27 days

Secondary Outcomes (14)

  • DWC202211 Tmax,ss

    up to 27 days

  • DWC202211 T1/2,ss

    up to 27 days

  • DWC202211 Cmin,ss

    up to 27 days

  • DWC202211 Cavg,ss

    up to 27 days

  • DWC202211 CLss/F

    up to 27 days

  • +9 more secondary outcomes

Study Arms (3)

DWC202211

EXPERIMENTAL
Drug: DWC202211 100mg

DWC202212

EXPERIMENTAL
Drug: DWC202212 5mg

DWC202211 + DWC202212

EXPERIMENTAL
Drug: DWC202211 100mg + DWC202212 5mg

Interventions

DWC202211 100mgDRUG

DWC202211 for 5 days Aspirin 100mg

DWC202211
DWC202212 5mgDRUG

DWC202212 for 3 days Rabeprazole 5mg

DWC202212
DWC202211 100mg + DWC202212 5mgDRUG

DWC202211 + DWC202212 for 5 days Aspirin 100mg, Rabeprazole 5mg

DWC202211 + DWC202212

Eligibility Criteria

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

You may qualify if:

  • Healthy adults aged ≥ 19 and ≤ 50 years at screening
  • Subjects with a body weight ≥ 50.0 kg to ≤ 90.0 kg with a body mass index (BMI) of ≥ 18.0 kg/m2 to ≤ 27.0 kg/m2 at screening
  • ※ BMI (kg/m2) = body weight (kg)/\[height (m)\]2
  • Subjects who voluntarily decided to participate in the study and provided written consent to follow precautions after receiving a sufficient explanation on this study and fully understanding the information
  • Subjects who are eligible to participate in the study at the discretion of the investigator by physical examination, laboratory tests, and investigator questioning, etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Study Design

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

Study Record Dates

First Submitted

January 10, 2023

First Posted

January 26, 2023

Study Start

February 15, 2023

Primary Completion

April 24, 2023

Study Completion

June 1, 2023

Last Updated

April 4, 2023

Record last verified: 2023-01

Locations

KR(1)