Pharmacokinetic Study of AR882 in Subjects With Various Degrees of Renal Impairment

Arthrosi Therapeutics

Status and phase: Completed; Phase 1

Conditions: Renal Impairment

Treatments: Drug: AR882 Single Dose; Drug: AR882 Multiple Dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT04646889

AR882-104

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Renal Impairment

Experimental group

Description:

Subjects with various degrees of renal impairment

Treatment:

Drug: AR882 Single Dose

Drug: AR882 Multiple Dose

Normal Renal Function

Experimental group

Description:

Subjects with normal renal function

Treatment:

Drug: AR882 Single Dose

Drug: AR882 Multiple Dose