NCT07495514

Brief Summary

A Study to Evaluate the Effect of Food on the Pharmacokinetic Characteristics and Safety Profile of AD-117 in Healthy Adult Volunteers

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2026

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

February 10, 2026

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2026

Completed
Last Updated

July 15, 2026

Status Verified

July 1, 2026

Enrollment Period

2 months

First QC Date

March 9, 2026

Last Update Submit

July 14, 2026

Conditions

Mixed DyslipidemiaFood Effect Study of AD-117

Outcome Measures

Primary Outcomes (2)

  • Maximum concentration of drug in plasma (Cmax)

    Cmax of AD-117

    0-72 hours

  • Area under the plasma concentration-time curve during dosing interval (AUCt)

    AUCt of AD-117

    0-72 hours

Study Arms (2)

Sequence A

EXPERIMENTAL

Period 1: Fasted, Period 2: Fed

Drug: AD-117

Sequence B

EXPERIMENTAL

Period 1: Fed, Period 2: Fasted

Drug: AD-117

Interventions

AD-117DRUG

AD-117 1Tab., Per Oral

Sequence ASequence B

Eligibility Criteria

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

You may qualify if:

  • Body weight equal to or greater than 50kg (Female 45kg) and Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit
  • Healthy volunteers aged ≥19 and \<65 years at the time of screening visit

You may not qualify if:

  • Participation in another clinical study with an investigational drug within the 6 months from scheduled first administration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

H PLUS YANGJI HOSPITAL, Seoul,

Seoul, 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

March 9, 2026

First Posted

March 27, 2026

Study Start

February 10, 2026

Primary Completion

April 9, 2026

Study Completion

April 9, 2026

Last Updated

July 15, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)