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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04347005
• Other study ID #: AR882-101
• Status: Completed
• Phase: Phase 1
• Start date: January 22, 2019
• Est. completion date: July 31, 2019

Study information

• Verified date: March 2020
• Source: Arthrosi Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Cohort 1: AR882
Single dose of AR882 or matching placebo
• Cohort 2: AR882
Single dose of AR882 or matching placebo
• Cohort 3: AR882
Single dose of AR882 or matching placebo
• Cohort 4: AR882
Single dose of AR882 or matching placebo
• Cohort 5: AR882
Single dose of AR882 or matching placebo
• Cohort 6: AR882 Food Effect
Single dose of AR882 or matching placebo in a fed state
• Cohort 7: AR882 Solid Oral Formulation
Single dose of AR882 or matching placebo
• 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
• 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

Locations

Country	Name	City	State
Australia	Nucleus Network Pty, Ltd.	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Arthrosi Therapeutics

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety profile of AR882 based on incidence of abnormal laboratory findings	Analysis of abnormal safety laboratory findings	8 Days
Primary	Safety Analyses	ECG Heart Rate	8 Days
Primary	Safety Analyses	ECG PR-Interval	8 Days
Primary	Safety Analyses	ECG RR-Interval	8 Days
Primary	Safety Analyses	ECG QRS-Interval	8 Days
Primary	Safety Analyses	ECG QT-Interval	8 Days
Primary	Safety Analyses	ECG QTc-Interval	8 Days
Primary	Safety Analyses	Vital Sign - Systolic Blood Pressure	8 Days
Primary	Safety Analyses	Vital Sign - Diastolic Blood Pressure	8 Days
Primary	Safety Analyses	Vital Sign - Pulse Rate	8 Days
Primary	Safety Analyses	Vital Sign - Body Temperature	8 Days
Primary	Safety Analyses	Vital Sign - Respiratory Rate	8 Days
Primary	Area under the curve (AUC) for plasma AR882	Profile from plasma in terms of AUC for AR882	6 Days
Primary	Time to maximum plasma concentration (Tmax) for AR882	Profile from plasma in terms of Tmax for AR882	6 Days
Primary	Maximum plasma concentration (Cmax) for AR882	Profile from plasma in terms of Cmax for AR882	6 Days
Primary	Apparent terminal half-life (t1/2) for AR882	Profile from plasma in terms of t1/2 for AR882	6 Days
Primary	Amount excreted (Ae) into urine for AR882	Profile from urine in terms of Ae for AR882	6 Days
Primary	Fractional Excretion (FEUA) for AR882	Profile from urine in terms of FEUA for AR882	6 Days
Secondary	PD profile of a single dose of AR882	Profile from serum uric acid concentrations over time	6 Days
Secondary	PD profile of a single dose of AR882 in combination with allopurinol	Profile from serum uric acid concentrations over time	6 Days
Secondary	PD profile of a single dose of AR882 in combination with febuxostat	Profile from serum uric acid concentrations over time	6 Days