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

Completed · Phase 1

Conditions studied: Renal Impairment

In brief

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.

Key facts

Study ID

NCT04646889

Run by

Arthrosi Therapeutics

People needed

46

Starts

2021-01-14

Expected to finish

2022-06-27

Last updated by the study team

2022-08-05

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Arthrosi Investigative Site — Orlando, Florida, United States
• Arthrosi Investigative Site — Dallas, Texas, United States
• Arthrosi Investigative Site — Auckland, New Zealand
• Arthrosi Investigative Site — Christchurch, New Zealand

Full record on ClinicalTrials.gov

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