Multiple Ascending Dose Study of AR882 in Healthy Adult Male Volunteers

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04314986
• Other study ID #: AR882-102
• Status: Completed
• Phase: Phase 1
• Start date: June 28, 2019
• Est. completion date: September 18, 2019

Study information

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

Clinical Trial Summary

A study to assess multiple ascending doses of AR882 in healthy adult males.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 18, 2019
• Est. primary completion date: September 18, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Screening serum uric acid level = 4.5 mg/dL (268 µmol/L) and < 9 mg/dL (535 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 or placebo
AR882 or matching placebo administered once daily for 10 days
• Cohort 2: AR882 or placebo
AR882 or matching placebo administered once daily for 10 days.
• Cohort 3: AR882 or placebo
AR882 or matching placebo administered once daily for 10 days
• Cohort 4: AR882 or placebo
AR882 or matching placebo administered once daily for 10 days

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 adverse events	Incidence of adverse events following multiple doses of AR882	22 Days
Primary	To evaluate the safety profile of AR882 based on incidence of abnormal laboratory findings	Incidence of abnormal laboratory findings following multiple doses of AR882	22 Days
Primary	To evaluate the safety profile of AR882 based on incidence of abnormal electrocardiogram findings	Incidence of abnormal electrocardiogram findings following multiple doses of AR882	22 Days
Primary	To evaluate the safety profile of AR882 based on incidence of abnormal vital signs findings	Incidence of abnormal vital signs findings following multiple doses of AR882	22 Days
Primary	Area under the curve (AUC) for plasma AR882	Profile from plasma in terms of AUC following multiple doses of AR882	15 Days
Primary	Time to maximum plasma concentration (Tmax) for AR882	Profile from plasma in terms of Tmax following multiple doses of AR882	15 Days
Primary	Maximum plasma concentration (Cmax) for AR882	Profile from plasma in terms of Cmax following multiple doses of AR882	15 Days
Primary	Apparent terminal half-life (t1/2) for AR882	Profile from plasma in terms of t1/2 following multiple doses of AR882	15 Days
Primary	Amount excreted (Ae) into urine for AR882	Profile from urine in terms of Ae following multiple doses of AR882	15 Days
Primary	Fractional Excretion (FEUA) for AR882	Profile from urine in terms of FEUA following multiple doses of AR882	15 Days
Secondary	PD profile following multiple doses of AR882	Profile from serum uric acid concentrations over time	15 Days