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

Sponsor
Addpharma Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05703282
Collaborator
(none)
32
1
4
10
3.2

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Cmax [pre-dose to 192 hours]

    To assess the Cmax of AD-104-A

  2. AUC [pre-dose to 192 hours]

    To assess the AUC of AD-104-A

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul National University Hospital Seoul Jongno-gu Korea, Republic of 03080

Sponsors and Collaborators

  • Addpharma Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Addpharma Inc.
ClinicalTrials.gov Identifier:
NCT05703282
Other Study ID Numbers:
  • AD-104PK_N
First Posted:
Jan 30, 2023
Last Update Posted:
Jan 30, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 30, 2023