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

Phase 1

Completed

• Conditions: Renal Impairment
• Interventions: Drug: AR882 Single Dose; Drug: AR882 Multiple Dose

• Registration Number: NCT04646889
• Lead Sponsor: Arthrosi Therapeutics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-18
• Study First Submitted QC: 2020-11-27
• Study First Posted: 2020-11-30
• Study Start: 2021-01-14
• Primary Completion: 2022-06-27
• Study Completion: 2022-06-27
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-03
• Last Update Posted: 2022-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal Renal Function	AR882 Multiple Dose	Subjects with normal renal function
Renal Impairment	AR882 Multiple Dose	Subjects with various degrees of renal impairment
Normal Renal Function	AR882 Single Dose	Subjects with normal renal function
Renal Impairment	AR882 Single Dose	Subjects with various degrees of renal impairment

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Arthrosi Investigative Site; 🇳🇿 Christchurch, New Zealand