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

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

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.

Study Overview

• Status: Completed
• Conditions: Renal Impairment
• Intervention / Treatment: Drug: AR882 Single Dose; Drug: AR882 Multiple Dose

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 1

Contacts and Locations

Study Locations

• New Zealand
  • Auckland, New Zealand
    • Arthrosi Investigative Site
  • Christchurch, New Zealand
    • Arthrosi Investigative Site
• United States
  • Florida
    • Orlando, Florida, United States, 32809
      • Arthrosi Investigative Site
  • Texas
    • Dallas, Texas, United States, 75230
      • Arthrosi Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Renal Impairment; Subjects with various degrees of renal impairment	Drug: AR882 Single Dose; A single dose of AR882; Drug: AR882 Multiple Dose; AR882 taken once daily for 14 days
EXPERIMENTAL: Normal Renal Function; Subjects with normal renal function	Drug: AR882 Single Dose; A single dose of AR882; Drug: AR882 Multiple Dose; AR882 taken once daily for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Arthrosi Therapeutics
• Collaborators: IQVIA Pty Ltd
• Investigators: Study Director: Vijay Hingorani, MD, PhD, MBA, Arthrosi Therapeutics

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 14, 2021
• Primary Completion (ACTUAL): June 27, 2022
• Study Completion (ACTUAL): June 27, 2022

Study Registration Dates

• First Submitted: November 18, 2020
• First Submitted That Met QC Criteria: November 27, 2020
• First Posted (ACTUAL): November 30, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 5, 2022
• Last Update Submitted That Met QC Criteria: August 3, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency
• Other Study ID Numbers: AR882-104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No