NCT07319559

Brief Summary

This study aimed to evaluate the safety and pharmacokinetic characteristics of DW5124 and DW5124-R, and the effect of food on DW5124, in healthy adult volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2025

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

Study Start

First participant enrolled

May 8, 2025

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2025

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 6, 2026

Completed
Last Updated

January 6, 2026

Status Verified

December 1, 2025

Enrollment Period

3 days

First QC Date

December 22, 2025

Last Update Submit

December 22, 2025

Conditions

Mixed Dyslipidemia

Outcome Measures

Primary Outcomes (2)

  • Peak Plasma Concentration (Cmax)

    Pharmacokinetics of DW5124-fed and DW5124-fasting, Pharmacokinetics of DW5124-fed and DW5124-R-fed

    up to 72 hour

  • Area under the plasma concentration versus time curve (AUC)

    Pharmacokinetics of DW5124-fed and DW5124-fasting, Pharmacokinetics of DW5124-fed and DW5124-R-fed

    up to 72 hour

Secondary Outcomes (4)

  • Time to maximum plasma concentration (Tmax)

    up to 72 hour

  • Terminal half life (t1/2)

    up to 72 hour

  • Apparent clearance (CL/F)

    up to 72 hour

  • Apparent volume of distribution (Vd/F)

    up to 72 hour

Study Arms (6)

Sequence A

EXPERIMENTAL

cross-over

Drug: DW5124Drug: DW5124-R

Sequence B

EXPERIMENTAL

cross-over

Drug: DW5124Drug: DW5124-R

Sequence C

EXPERIMENTAL

cross-over

Drug: DW5124Drug: DW5124-R

Sequence D

EXPERIMENTAL

cross-over

Drug: DW5124Drug: DW5124-R

Sequence E

EXPERIMENTAL

cross-over

Drug: DW5124Drug: DW5124-R

Sequence F

EXPERIMENTAL

cross-over

Drug: DW5124Drug: DW5124-R

Interventions

DW5124DRUG

DW5124 on fasted or fed condition

Sequence ASequence BSequence CSequence DSequence ESequence F
DW5124-RDRUG

DW5124-R on fasted or fed condition

Sequence ASequence BSequence CSequence DSequence ESequence F

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy Volunteers who are ≥19 years and \>65 years old
  • Body weight ≥50.0 kg and BMI between 18.0 and 30.0 kg/m2

You may not qualify if:

  • Clinically significant Medical History
  • In the case of women, pregnant(Urine-HCG positive) or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chungbuk National University Hospital

Cheongju-si, South Korea

Location

Study Design

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

Study Record Dates

First Submitted

December 22, 2025

First Posted

January 6, 2026

Study Start

May 8, 2025

Primary Completion

May 11, 2025

Study Completion

June 5, 2025

Last Updated

January 6, 2026

Record last verified: 2025-12

Locations

KR(1)