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Completed

NCT Number: NCT05703282

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

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

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Key information

Conditions

Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AD-104-A

Drug

PO, Single-Dose, AD-104-A

Primary outcomes

  1. Cmax

    Time frame: pre-dose to 192 hours

    To assess the Cmax of AD-104-A

  2. AUC

    Time frame: pre-dose to 192 hours

    To assess the AUC of AD-104-A

Sponsors and collaborators

Lead sponsor

Addpharma Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 30, 2023
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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