- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04314986
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
Status
Completed
Conditions
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.
Sponsor
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.
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