A Study to Assess the Safety and Pharmacokinetics of AD-1... | NCT05703282

Studies
A Study to Assess the Safety and Pharmacokinetics of AD-104-A

NCT05703282

Sponsor

Addpharma Inc.

Status

Completed

Last Update Posted

Aug 1, 2024Actual

Enrollment

32Actual

Phase

Phase 1

Conditions

Hyperlipidemias

Interventions

AD-104-A

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

Jul 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 13, 2023Actual

Primary Completion Date

Apr 5, 2024Actual

Completion Date

Apr 5, 2024Actual

First Submitted Date

Jan 18, 2023

First Submission Date that Met QC Criteria

Jan 26, 2023

First Posted Date

Jan 30, 2023Actual

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

Jul 30, 2024

Last Update Posted Date

Aug 1, 2024Actual

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 AD-104-A

Detailed Description

The purpose of this study is to evaluate the pharmacokinetic characteristics of AD-104-A in Healthy Adult Volunteers and Patients with Renal Impairment

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

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Renal Impairment 1	Experimental	Test Drug: AD-104-A	Drug: AD-104-A
Renal Impairment 2	Experimental	Test Drug: AD-104-A	Drug: AD-104-A
Renal Impairment 3	Experimental	Test Drug: AD-104-A	Drug: AD-104-A
Normal	Experimental	Test Drug: AD-104-A	Drug: AD-104-A

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AD-104-A	Drug	PO, Single-Dose, AD-104-A	Normal Renal Impairment 1 Renal Impairment 2 Renal Impairment 3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cmax	To assess the Cmax of AD-104-A	pre-dose to 192 hours
AUC	To assess the AUC of AD-104-A	pre-dose to 192 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

For all subjects

Adults aged 19 years and older
Body mass index(BMI) of 18 to 30 kg/m2
Voluntarily given written informed consent

For renal Impairment subjects

30 ≤ eGFR < 90 mL/min/1.73m^2

For healthy subjects

eGFR ≥ 90 mL/min/1.73m^2

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

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul	Jongno-gu	03080	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D006949	Hyperlipidemias

Ancestor Terms

ID	Term
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided