A Phase 1, Pharmacokinetic and Pharmacodynamic Study of AR882 in Adult Volunteers With Various Degrees of Renal Impairment
Overview
- Phase
- Phase 1
- Intervention
- AR882 Single Dose
- Conditions
- Renal Impairment
- Sponsor
- Arthrosi Therapeutics
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- Area under the curve (AUC) for plasma following a single dose of AR882 in subjects with renal impairment and normal renal function
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •All Subjects:
- •Males and non-pregnant, non-lactating females
- •Body weight no less than 50 kg
- •sUA greater than or equal to 4.0 mg/dL
- •Renal Impaired Subjects:
- •History of chronic renal impairment (\> 6 months)
Exclusion Criteria
- •All Subjects:
- •Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin
- •History of cardiac abnormalities
- •Active peptic ulcer disease or active liver disease
- •History of kidney stones
- •Renal Impaired Subjects:
- •Requires dialysis
Arms & Interventions
Renal Impairment
Subjects with various degrees of renal impairment
Intervention: AR882 Single Dose
Renal Impairment
Subjects with various degrees of renal impairment
Intervention: AR882 Multiple Dose
Normal Renal Function
Subjects with normal renal function
Intervention: AR882 Single Dose
Normal Renal Function
Subjects with normal renal function
Intervention: AR882 Multiple Dose
Outcomes
Primary Outcomes
Area under the curve (AUC) for plasma following a single dose of AR882 in subjects with renal impairment and normal renal function
Time Frame: 6 days
Time to maximum plasma concentration (Tmax) following a single dose of AR882 in subjects with renal impairment and normal renal function
Time Frame: 6 days
Maximum plasma concentration (Cmax) following a single dose of AR882 in subjects with renal impairment and normal renal function
Time Frame: 6 days
Terminal half-life (t 1/2) following a single dose of AR882 in subjects with renal impairment and normal renal function
Time Frame: 6 days
Amount excreted (Ae) into urine following a single dose of AR882 in subjects with renal impairment and normal renal function
Time Frame: 6 days
Renal clearance (CLr) following a single dose of AR882 in subjects with renal impairment and normal renal function
Time Frame: 6 days
AUC for plasma following multiple doses of AR882 in subjects with renal impairment and normal renal function
Time Frame: 15 days
Tmax following multiple doses of AR882 in subjects with renal impairment and normal renal function
Time Frame: 15 days
Cmax following multiple doses of AR882 in subjects with renal impairment and normal renal function
Time Frame: 15 days
t 1/2 following multiple doses of AR882 in subjects with renal impairment and normal renal function
Time Frame: 15 days
Secondary Outcomes
- 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(21 days)