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

Addpharma Inc.32 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hyperlipidemias

Interventions

AD-104-ADRUG

PO, Single-Dose, AD-104-A

Eligibility

Sex: ALLMin age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, Jongno-gu, South Korea

Outcomes

Primary Outcomes

Cmax

To assess the Cmax of AD-104-A

Time frame: pre-dose to 192 hours

AUC

To assess the AUC of AD-104-A

Time frame: pre-dose to 192 hours

Data from ClinicalTrials.gov

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