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

Renal Impairment Clinical Trial

Official title:

A Phase 1, Pharmacokinetic and Pharmacodynamic Study of AR882 in Adult Volunteers With Various Degrees of Renal Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04646889
• Other study ID #: AR882-104
• Status: Completed
• Phase: Phase 1
• Start date: January 14, 2021
• Est. completion date: June 27, 2022

Study information

• Verified date: August 2022
• Source: Arthrosi Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: June 27, 2022
• Est. primary completion date: June 27, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Renal Impairment
• Renal Insufficiency

Intervention

Drug:
• AR882 Single Dose
A single dose of AR882
• AR882 Multiple Dose
AR882 taken once daily for 14 days

Locations

Country	Name	City	State
New Zealand	Arthrosi Investigative Site	Auckland
New Zealand	Arthrosi Investigative Site	Christchurch
United States	Arthrosi Investigative Site	Dallas	Texas
United States	Arthrosi Investigative Site	Orlando	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Arthrosi Therapeutics	Iqvia Pty Ltd

Countries where clinical trial is conducted

United States,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve (AUC) for plasma following a single dose of AR882 in subjects with renal impairment and normal renal function		6 days
Primary	Time to maximum plasma concentration (Tmax) following a single dose of AR882 in subjects with renal impairment and normal renal function		6 days
Primary	Maximum plasma concentration (Cmax) following a single dose of AR882 in subjects with renal impairment and normal renal function		6 days
Primary	Terminal half-life (t 1/2) following a single dose of AR882 in subjects with renal impairment and normal renal function		6 days
Primary	Amount excreted (Ae) into urine following a single dose of AR882 in subjects with renal impairment and normal renal function		6 days
Primary	Renal clearance (CLr) following a single dose of AR882 in subjects with renal impairment and normal renal function		6 days
Primary	AUC for plasma following multiple doses of AR882 in subjects with renal impairment and normal renal function		15 days
Primary	Tmax following multiple doses of AR882 in subjects with renal impairment and normal renal function		15 days
Primary	Cmax following multiple doses of AR882 in subjects with renal impairment and normal renal function		15 days
Primary	t 1/2 following multiple doses of AR882 in subjects with renal impairment and normal renal function		15 days
Secondary	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
Secondary	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