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

Phase 1CompletedNCT04347005

Arthrosi Therapeutics64 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Healthy Volunteers

Interventions

Cohort 1: AR882DRUG

Single dose of AR882 or matching placebo

Cohort 2: AR882DRUG

Single dose of AR882 or matching placebo

Cohort 3: AR882DRUG

Single dose of AR882 or matching placebo

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Nucleus Network Pty, Ltd.

Melbourne, Victoria, Australia

Outcomes

Primary Outcomes

To evaluate the safety profile of AR882 based on incidence of abnormal laboratory findings

Analysis of abnormal safety laboratory findings

Time frame: 8 Days

Safety Analyses

ECG Heart Rate

Time frame: 8 Days

Safety Analyses

ECG PR-Interval

Time frame: 8 Days

Safety Analyses

ECG RR-Interval

Time frame: 8 Days

Safety Analyses

ECG QRS-Interval

Time frame: 8 Days

Safety Analyses

ECG QT-Interval

Time frame: 8 Days

Safety Analyses

ECG QTc-Interval

Time frame: 8 Days

Safety Analyses

Vital Sign - Systolic Blood Pressure

Time frame: 8 Days

Safety Analyses

Vital Sign - Diastolic Blood Pressure

Time frame: 8 Days

Safety Analyses

Vital Sign - Pulse Rate

Time frame: 8 Days

Safety Analyses

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Single dose of AR882 or matching placebo

Cohort 5: AR882DRUG

Single dose of AR882 or matching placebo

Cohort 6: AR882 Food EffectDRUG

Single dose of AR882 or matching placebo in a fed state

Cohort 7: AR882 Solid Oral FormulationDRUG

Single dose of AR882 or matching placebo

Cohort 8: AR882 in combination with allopurinolDRUG

Single dose of allopurinol alone and a single dose of AR882 in combination with a single dose of allopurinol

Cohort 9: AR882 in combination with febuxostatDRUG

Single dose of febuxostat alone and a single dose of AR882 in combination with a single dose of febuxostat

Vital Sign - Body Temperature

Safety Analyses

Vital Sign - Respiratory Rate

Time frame: 8 Days

Area under the curve (AUC) for plasma AR882

Profile from plasma in terms of AUC for AR882

Time frame: 6 Days

Time to maximum plasma concentration (Tmax) for AR882

Profile from plasma in terms of Tmax for AR882

Time frame: 6 Days

Maximum plasma concentration (Cmax) for AR882

Profile from plasma in terms of Cmax for AR882

Time frame: 6 Days

Apparent terminal half-life (t1/2) for AR882

Profile from plasma in terms of t1/2 for AR882

Time frame: 6 Days

Amount excreted (Ae) into urine for AR882

Profile from urine in terms of Ae for AR882

Time frame: 6 Days

Fractional Excretion (FEUA) for AR882

Profile from urine in terms of FEUA for AR882

Time frame: 6 Days

Secondary Outcomes

PD profile of a single dose of AR882

Profile from serum uric acid concentrations over time

Time frame: 6 Days

PD profile of a single dose of AR882 in combination with allopurinol

Profile from serum uric acid concentrations over time

Time frame: 6 Days

PD profile of a single dose of AR882 in combination with febuxostat

Profile from serum uric acid concentrations over time

Time frame: 6 Days