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| Name | Class |
|---|---|
| IQVIA Pty Ltd | INDUSTRY |
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This is a 2-segment, multi-center, phase 1, open-label, study evaluating the pharmacokinetics and pharmacodynamics of AR882 in subjects with various degrees of renal impairment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal Impairment | Experimental | Subjects with various degrees of renal impairment |
|
| Normal Renal Function | Experimental | Subjects with normal renal function |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AR882 Single Dose | Drug | A single dose of AR882 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve (AUC) for plasma following a single dose of AR882 in subjects with renal impairment and normal renal function | 6 days | |
| Time to maximum plasma concentration (Tmax) following a single dose of AR882 in subjects with renal impairment and normal renal function | 6 days | |
| Maximum plasma concentration (Cmax) following a single dose of AR882 in subjects with renal impairment and normal renal function | 6 days | |
| Terminal half-life (t 1/2) following a single dose of AR882 in subjects with renal impairment and normal renal function | 6 days | |
| Amount excreted (Ae) into urine following a single dose of AR882 in subjects with renal impairment and normal renal function | 6 days | |
| Renal clearance (CLr) following a single dose of AR882 in subjects with renal impairment and normal renal function | 6 days | |
| AUC for plasma following multiple doses of AR882 in subjects with renal impairment and normal renal function | 15 days | |
| Tmax following multiple doses of AR882 in subjects with renal impairment and normal renal function | 15 days | |
| Cmax following multiple doses of AR882 in subjects with renal impairment and normal renal function | 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events, changes in laboratory, electrocardiogram, and vital signs following a single dose of AR882 in subjects with renal impairment and normal renal function | 14 days | |
| Incidence of Adverse Events, changes in laboratory, electrocardiogram, and vital signs following multiple doses of AR882 in subjects with renal impairment and normal renal function |
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Inclusion Criteria:
All Subjects:
Renal Impaired Subjects:
• History of chronic renal impairment (> 6 months)
Exclusion Criteria:
All Subjects:
Renal Impaired Subjects:
• Requires dialysis
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| Name | Affiliation | Role |
|---|---|---|
| Vijay Hingorani, MD, PhD, MBA | Arthrosi Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arthrosi Investigative Site | Orlando | Florida | 32809 | United States | ||
| Arthrosi Investigative Site |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| AR882 Multiple Dose |
| Drug |
AR882 taken once daily for 14 days |
|
| t 1/2 following multiple doses of AR882 in subjects with renal impairment and normal renal function | 15 days |
| 21 days |
| Dallas |
| Texas |
| 75230 |
| United States |
| Arthrosi Investigative Site | Auckland | New Zealand |
| Arthrosi Investigative Site | Christchurch | New Zealand |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |