A Study to Assess the Safety and Pharmacokinetics of AD-104-A
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
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
- Cmax [pre-dose to 192 hours]
To assess the Cmax of AD-104-A
- AUC [pre-dose to 192 hours]
To assess the AUC of AD-104-A
Eligibility Criteria
Criteria
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.- AD-104PK_N