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

• Status: Recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Arthrosi Therapeutics
• Collaborator: Iqvia Pty Ltd

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