Multiple Ascending Dose Study of AR882 in Healthy Adult Male Volunteers

November 12, 2020 updated by: Arthrosi Therapeutics

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

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

Study Overview

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
AR882 or matching placebo administered once daily for 10 days
AR882 or matching placebo administered once daily for 10 days.
AR882 or matching placebo administered once daily for 10 days
AR882 or matching placebo administered once daily for 10 days
Experimental: AR882 (Dose A)
AR882 or matching placebo administered once daily for 10 days
Experimental: AR882 (Dose B)
AR882 or matching placebo administered once daily for 10 days.
Experimental: AR882 (Dose C)
AR882 or matching placebo administered once daily for 10 days
Experimental: AR882 (Dose D)
AR882 or matching placebo administered once daily for 10 days

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PD profile following multiple doses of AR882
Time Frame: 15 Days
Profile from serum uric acid concentrations over time
15 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2019

Primary Completion (Actual)

September 18, 2019

Study Completion (Actual)

September 18, 2019

Study Registration Dates

First Submitted

March 10, 2020

First Submitted That Met QC Criteria

March 17, 2020

First Posted (Actual)

March 19, 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

Other Study ID Numbers

  • AR882-102

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy Volunteers

Clinical Trials on Cohort 1: AR882 or placebo

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