Back to resultsA Study to Assess the Safety and Pharmacokinetics of AD-104-A
Primary Purpose
Hyperlipidemias
Status
Recruiting
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
AD-104-A
Sponsored by
About this trial
This is an interventional treatment trial for Hyperlipidemias
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
Sites / Locations
- Seoul National University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Renal Impairment 1
Renal Impairment 2
Renal Impairment 3
Normal
Arm Description
Test Drug: AD-104-A
Test Drug: AD-104-A
Test Drug: AD-104-A
Test Drug: AD-104-A
Outcomes
Primary Outcome Measures
Cmax
To assess the Cmax of AD-104-A
AUC
To assess the AUC of AD-104-A
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05703282
Brief Title
A Study to Assess the Safety and Pharmacokinetics of AD-104-A
Official Title
A Parallel, Open-Label, Single-Dose Administration, Phase 1 Clinical Study to Assess the Safety and Pharmacokinetics of AD-104-A in Healthy Adult Volunteers and Patients With Renal Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 13, 2023 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Addpharma Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemias
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Renal Impairment 1
Arm Type
Experimental
Arm Description
Test Drug: AD-104-A
Arm Title
Renal Impairment 2
Arm Type
Experimental
Arm Description
Test Drug: AD-104-A
Arm Title
Renal Impairment 3
Arm Type
Experimental
Arm Description
Test Drug: AD-104-A
Arm Title
Normal
Arm Type
Experimental
Arm Description
Test Drug: AD-104-A
Intervention Type
Drug
Intervention Name(s)
AD-104-A
Intervention Description
PO, Single-Dose, AD-104-A
Primary Outcome Measure Information:
Title
Cmax
Description
To assess the Cmax of AD-104-A
Time Frame
pre-dose to 192 hours
Title
AUC
Description
To assess the AUC of AD-104-A
Time Frame
pre-dose to 192 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeong Eun Park
Phone
82-031-891-6989
Email
parkje@addpharma.co.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Seung Hwan Lee, M.D., Ph.D.
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Jongno-gu
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seung Hwan Lee, M.D., Ph.D.
12. IPD Sharing Statement
Learn more about this trial
A Study to Assess the Safety and Pharmacokinetics of AD-104-A
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