The Food Effect on PK Characteristics and Safety Profiles... | NCT06976489

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

NCT06976489

Sponsor

Addpharma Inc.

Status

Not yet recruiting

Last Update Posted

May 16, 2025Actual

Enrollment

40Estimated

Phase

Phase 1

Conditions

Mixed Dyslipidemia

Interventions

PA-111

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2025Estimated

Primary Completion Date

Jul 2025Estimated

Completion Date

Jul 2025Estimated

First Submitted Date

May 9, 2025

First Submission Date that Met QC Criteria

May 9, 2025

First Posted Date

May 16, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 9, 2025

Last Update Posted Date

May 16, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sequence A	Experimental	Period 1: Fasted, Period 2: Fed	Drug: PA-111
Sequence B	Experimental	Period 1: Fed, Period 2: Fasted	Drug: PA-111

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PA-111	Drug	PA-111 1Tab., Per Oral	Sequence A Sequence B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum concentration of drug in plasma (Cmax)	Cmax of PA-111	pre-dose (0hour) to 72hours
Area under the plasma concentration-time curve during dosing interval (AUCt)	AUCt of PA-111	pre-dose (0hour) to 72hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
JeongEun Park	Contact	+82-31-891-6989		parkje@addpharma.co.kr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
H Plus Yangji Hospital		Seoul			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided