The Study is Designed to Evaluate Single Ascending Doses of AR882 in Healthy Adult Males

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Rising Dose Study of AR882, a Potent Uricosuric Agent, in Healthy Adult Male Volunteers

A randomized, double-blind, placebo-controlled, single ascending dose study of AR882 in healthy adult males.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Cohort 1: AR882; Drug: Cohort 2: AR882; Drug: Cohort 6: AR882 Food Effect; Drug: Cohort 8: AR882 in combination with allopurinol; Drug: Cohort 9: AR882 in combination with febuxostat; Drug: Cohort 3: AR882; Drug: Cohort 4: AR882; Drug: Cohort 5: AR882; Drug: Cohort 7: AR882 Solid Oral Formulation

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Nucleus Network Pty, Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Serum uric acid level ≥ 4.5 mg/dL (268 µmol/L)
• Body weight no less than 50 kg and body mass index (BMI) within the range of ≥18 and ≤33 kg/m2
• Must be free of any clinically significant disease that requires a physician's care and/or would interfere with study evaluations or procedures

Exclusion Criteria:

• Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin
• History of cardiac abnormalities
• History and/or presence of drug addiction or excessive use of alcohol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Cohort 1: AR882; Single dose of AR882 or matching placebo; Drug: Cohort 2: AR882; Single dose of AR882 or matching placebo; Drug: Cohort 6: AR882 Food Effect; Single dose of AR882 or matching placebo in a fed state; Drug: Cohort 3: AR882; Single dose of AR882 or matching placebo; Drug: Cohort 4: AR882; Single dose of AR882 or matching placebo; Drug: Cohort 5: AR882; Single dose of AR882 or matching placebo; Drug: Cohort 7: AR882 Solid Oral Formulation; Single dose of AR882 or matching placebo
Experimental: AR882 (Dose A)	Drug: Cohort 1: AR882; Single dose of AR882 or matching placebo
Experimental: AR882 (Dose B)	Drug: Cohort 2: AR882; Single dose of AR882 or matching placebo; Drug: Cohort 6: AR882 Food Effect; Single dose of AR882 or matching placebo in a fed state; Drug: Cohort 8: AR882 in combination with allopurinol; Single dose of allopurinol alone and a single dose of AR882 in combination with a single dose of allopurinol; Drug: Cohort 9: AR882 in combination with febuxostat; Single dose of febuxostat alone and a single dose of AR882 in combination with a single dose of febuxostat
Experimental: AR882 (Dose C)	Drug: Cohort 3: AR882; Single dose of AR882 or matching placebo
Experimental: AR882 (Dose D)	Drug: Cohort 4: AR882; Single dose of AR882 or matching placebo
Experimental: AR882 (Dose E)	Drug: Cohort 5: AR882; Single dose of AR882 or matching placebo
Experimental: AR882 (Dose B) Solid Oral Formulation	Drug: Cohort 7: AR882 Solid Oral Formulation; Single dose of AR882 or matching placebo
Active Comparator: Allopurinol	Drug: Cohort 8: AR882 in combination with allopurinol; Single dose of allopurinol alone and a single dose of AR882 in combination with a single dose of allopurinol
Active Comparator: Febuxostat	Drug: Cohort 9: AR882 in combination with febuxostat; Single dose of febuxostat alone and a single dose of AR882 in combination with a single dose of febuxostat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the safety profile of AR882 based on incidence of abnormal laboratory findings	Analysis of abnormal safety laboratory findings	8 Days
Safety Analyses	ECG Heart Rate	8 Days
Safety Analyses	ECG PR-Interval	8 Days
Safety Analyses	ECG RR-Interval	8 Days
Safety Analyses	ECG QRS-Interval	8 Days
Safety Analyses	ECG QT-Interval	8 Days
Safety Analyses	ECG QTc-Interval	8 Days
Safety Analyses	Vital Sign - Systolic Blood Pressure	8 Days
Safety Analyses	Vital Sign - Diastolic Blood Pressure	8 Days
Safety Analyses	Vital Sign - Pulse Rate	8 Days
Safety Analyses	Vital Sign - Body Temperature	8 Days
Safety Analyses	Vital Sign - Respiratory Rate	8 Days
Area under the curve (AUC) for plasma AR882	Profile from plasma in terms of AUC for AR882	6 Days
Time to maximum plasma concentration (Tmax) for AR882	Profile from plasma in terms of Tmax for AR882	6 Days
Maximum plasma concentration (Cmax) for AR882	Profile from plasma in terms of Cmax for AR882	6 Days
Apparent terminal half-life (t1/2) for AR882	Profile from plasma in terms of t1/2 for AR882	6 Days
Amount excreted (Ae) into urine for AR882	Profile from urine in terms of Ae for AR882	6 Days
Fractional Excretion (FEUA) for AR882	Profile from urine in terms of FEUA for AR882	6 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PD profile of a single dose of AR882	Profile from serum uric acid concentrations over time	6 Days
PD profile of a single dose of AR882 in combination with allopurinol	Profile from serum uric acid concentrations over time	6 Days
PD profile of a single dose of AR882 in combination with febuxostat	Profile from serum uric acid concentrations over time	6 Days

Collaborators and Investigators

• Sponsor: Arthrosi Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2019
• Primary Completion (Actual): July 31, 2019
• Study Completion (Actual): July 31, 2019

Study Registration Dates

• First Submitted: March 10, 2020
• First Submitted That Met QC Criteria: April 14, 2020
• First Posted (Actual): April 15, 2020

Study Record Updates

• Last Update Posted (Actual): November 16, 2020
• Last Update Submitted That Met QC Criteria: November 12, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Antimetabolites; Protective Agents; Antioxidants; Free Radical Scavengers; Gout Suppressants; Allopurinol; Febuxostat
• Other Study ID Numbers: AR882-101

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
• product manufactured in and exported from the U.S.: Yes