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

November 12, 2020 updated by: Arthrosi Therapeutics

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Australia
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

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: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Cohort 1: AR882
Single dose of AR882 or matching placebo
Drug: Cohort 2: AR882
Single dose of AR882 or matching placebo
Drug: Cohort 6: AR882 Food Effect
Single dose of AR882 or matching placebo in a fed state
Drug: Cohort 3: AR882
Single dose of AR882 or matching placebo
Drug: Cohort 4: AR882
Single dose of AR882 or matching placebo
Drug: Cohort 5: AR882
Single dose of AR882 or matching placebo
Drug: Cohort 7: AR882 Solid Oral Formulation
Single dose of AR882 or matching placebo
Experimental: AR882 (Dose A)
Drug: Cohort 1: AR882
Single dose of AR882 or matching placebo
Experimental: AR882 (Dose B)
Drug: Cohort 2: AR882
Single dose of AR882 or matching placebo
Drug: Cohort 6: AR882 Food Effect
Single dose of AR882 or matching placebo in a fed state
Drug: 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
Drug: 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
Experimental: AR882 (Dose C)
Drug: Cohort 3: AR882
Single dose of AR882 or matching placebo
Experimental: AR882 (Dose D)
Drug: Cohort 4: AR882
Single dose of AR882 or matching placebo
Experimental: AR882 (Dose E)
Drug: Cohort 5: AR882
Single dose of AR882 or matching placebo
Experimental: AR882 (Dose B) Solid Oral Formulation
Drug: Cohort 7: AR882 Solid Oral Formulation
Single dose of AR882 or matching placebo
Active Comparator: Allopurinol
Drug: 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
Active Comparator: Febuxostat
Drug: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To evaluate the safety profile of AR882 based on incidence of abnormal laboratory findings
Time Frame: 8 Days
Analysis of abnormal safety laboratory findings
8 Days
Safety Analyses
Time Frame: 8 Days
ECG Heart Rate
8 Days
Safety Analyses
Time Frame: 8 Days
ECG PR-Interval
8 Days
Safety Analyses
Time Frame: 8 Days
ECG RR-Interval
8 Days
Safety Analyses
Time Frame: 8 Days
ECG QRS-Interval
8 Days
Safety Analyses
Time Frame: 8 Days
ECG QT-Interval
8 Days
Safety Analyses
Time Frame: 8 Days
ECG QTc-Interval
8 Days
Safety Analyses
Time Frame: 8 Days
Vital Sign - Systolic Blood Pressure
8 Days
Safety Analyses
Time Frame: 8 Days
Vital Sign - Diastolic Blood Pressure
8 Days
Safety Analyses
Time Frame: 8 Days
Vital Sign - Pulse Rate
8 Days
Safety Analyses
Time Frame: 8 Days
Vital Sign - Body Temperature
8 Days
Safety Analyses
Time Frame: 8 Days
Vital Sign - Respiratory Rate
8 Days
Area under the curve (AUC) for plasma AR882
Time Frame: 6 Days
Profile from plasma in terms of AUC for AR882
6 Days
Time to maximum plasma concentration (Tmax) for AR882
Time Frame: 6 Days
Profile from plasma in terms of Tmax for AR882
6 Days
Maximum plasma concentration (Cmax) for AR882
Time Frame: 6 Days
Profile from plasma in terms of Cmax for AR882
6 Days
Apparent terminal half-life (t1/2) for AR882
Time Frame: 6 Days
Profile from plasma in terms of t1/2 for AR882
6 Days
Amount excreted (Ae) into urine for AR882
Time Frame: 6 Days
Profile from urine in terms of Ae for AR882
6 Days
Fractional Excretion (FEUA) for AR882
Time Frame: 6 Days
Profile from urine in terms of FEUA for AR882
6 Days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
PD profile of a single dose of AR882
Time Frame: 6 Days
Profile from serum uric acid concentrations over time
6 Days
PD profile of a single dose of AR882 in combination with allopurinol
Time Frame: 6 Days
Profile from serum uric acid concentrations over time
6 Days
PD profile of a single dose of AR882 in combination with febuxostat
Time Frame: 6 Days
Profile from serum uric acid concentrations over time
6 Days

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Arthrosi Therapeutics

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 22, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 15, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 16, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AR882-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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