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

Hyperlipidemias Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05703282
• Other study ID #: AD-104PK_N
• Status: Recruiting
• Phase: Phase 1
• Start date: March 13, 2023
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Addpharma Inc.
• Contact: Jeong Eun Park
• Phone: 82-031-891-6989
• Email: parkje[@]addpharma.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of AD-104-A

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: December 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperlipidemias

Intervention

Drug:
• AD-104-A
PO, Single-Dose, AD-104-A

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul	Jongno-gu

Sponsors (1)

Lead Sponsor	Collaborator
Addpharma Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	To assess the Cmax of AD-104-A	pre-dose to 192 hours
Primary	AUC	To assess the AUC of AD-104-A	pre-dose to 192 hours