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

July 30, 2024 updated by: Addpharma Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Jongno-gu
      • Seoul, Jongno-gu, Korea, Republic of, 03080
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Renal Impairment 1
Test Drug: AD-104-A
Drug: AD-104-A
PO, Single-Dose, AD-104-A
Experimental: Renal Impairment 2
Test Drug: AD-104-A
Drug: AD-104-A
PO, Single-Dose, AD-104-A
Experimental: Renal Impairment 3
Test Drug: AD-104-A
Drug: AD-104-A
PO, Single-Dose, AD-104-A
Experimental: Normal
Test Drug: AD-104-A
Drug: AD-104-A
PO, Single-Dose, AD-104-A

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Addpharma Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2023

Primary Completion (Actual)

April 5, 2024

Study Completion (Actual)

April 5, 2024

Study Registration Dates

First Submitted

January 18, 2023

First Submitted That Met QC Criteria

January 26, 2023

First Posted (Actual)

January 30, 2023

Study Record Updates

Last Update Posted (Actual)

August 1, 2024

Last Update Submitted That Met QC Criteria

July 30, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AD-104PK_N

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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