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Not yet recruitingNCT06976489Updated May 16, 2025

The Food Effect on PK Characteristics and Safety Profiles of PA-111

A Phase 1 interventional study of PA-111 in Mixed Dyslipidemia, sponsored by Addpharma Inc.. Not yet recruiting at 1 site in Korea, Republic of. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-16.

Sponsored by Addpharma Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 3 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of PA-111 in healthy subjects.

Read the detailed description

The purpose of this study is to compare and evaluate the effect of food on the safety and pharmacokinetic profiles of PA-111 in healthy adult subjects.

02

Conditions studied

  • Mixed Dyslipidemia

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03

In context

Dyslipidemias

1,073 studies on the registry are indexed under Dyslipidemias; 158 are open to participants now.

This study's planned enrollment of 40 is below the median of 99 across 842 interventional studies indexed under Dyslipidemias.

Browse Dyslipidemias studies →

Lead sponsor

Addpharma Inc. is the lead sponsor of 56 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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
  • The Age equal to or greater than 19 in healthy volunteers at the time of screening visit

Exclusion criteria

Exclusion Criteria:

  • Participation in another clinical study with an investigational drug within the 6 months from scheduled first administration
  • Other exclusions applied
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Sequence A

    Period 1: Fasted, Period 2: Fed

    Drug: PA-111

  • Experimental
    Sequence B

    Period 1: Fed, Period 2: Fasted

    Drug: PA-111

Interventions

  • DrugPA-111

    PA-111 1Tab., Per Oral

06

What researchers measure

Primary outcomes

  1. Maximum concentration of drug in plasma (Cmax)

    Cmax of PA-111

    Time frame: pre-dose (0hour) to 72hours

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

    AUCt of PA-111

    Time frame: pre-dose (0hour) to 72hours

07

Study locations

1 site
  • H Plus Yangji Hospital
    Seoul, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06976489
Lead sponsor
Addpharma Inc.
Responsible party
Sponsor
First posted
May 16, 2025
Start date
May 2025 (estimated)
Primary completion
Jul 2025 (estimated)
Completion
Jul 2025 (estimated)
Last update
May 16, 2025

Study contacts

JeongEun Park
Contact
parkje@addpharma.co.kr
+82-31-891-6989

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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