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OpenTrials
Completed

NCT Number: NCT04347005

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

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

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Nucleus Network Pty, Ltd.

Melbourne, Victoria, 3004, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cohort 1: AR882

Drug

Single dose of AR882 or matching placebo

Cohort 2: AR882

Drug

Single dose of AR882 or matching placebo

Cohort 3: AR882

Drug

Single dose of AR882 or matching placebo

Cohort 4: AR882

Drug

Single dose of AR882 or matching placebo

Cohort 5: AR882

Drug

Single dose of AR882 or matching placebo

Cohort 6: AR882 Food Effect

Drug

Single dose of AR882 or matching placebo in a fed state

Cohort 7: AR882 Solid Oral Formulation

Drug

Single dose of AR882 or matching placebo

Cohort 8: AR882 in combination with allopurinol

Drug

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

Drug

Single dose of febuxostat alone and a single dose of AR882 in combination with a single dose of febuxostat

Primary outcomes

  1. To evaluate the safety profile of AR882 based on incidence of abnormal laboratory findings

    Time frame: 8 Days

    Analysis of abnormal safety laboratory findings

  2. Safety Analyses

    Time frame: 8 Days

    ECG Heart Rate

  3. Safety Analyses

    Time frame: 8 Days

    ECG PR-Interval

  4. Safety Analyses

    Time frame: 8 Days

    ECG RR-Interval

  5. Safety Analyses

    Time frame: 8 Days

    ECG QRS-Interval

  6. Safety Analyses

    Time frame: 8 Days

    ECG QT-Interval

  7. Safety Analyses

    Time frame: 8 Days

    ECG QTc-Interval

  8. Safety Analyses

    Time frame: 8 Days

    Vital Sign - Systolic Blood Pressure

  9. Safety Analyses

    Time frame: 8 Days

    Vital Sign - Diastolic Blood Pressure

  10. Safety Analyses

    Time frame: 8 Days

    Vital Sign - Pulse Rate

  11. Safety Analyses

    Time frame: 8 Days

    Vital Sign - Body Temperature

  12. Safety Analyses

    Time frame: 8 Days

    Vital Sign - Respiratory Rate

  13. Area under the curve (AUC) for plasma AR882

    Time frame: 6 Days

    Profile from plasma in terms of AUC for AR882

  14. Time to maximum plasma concentration (Tmax) for AR882

    Time frame: 6 Days

    Profile from plasma in terms of Tmax for AR882

  15. Maximum plasma concentration (Cmax) for AR882

    Time frame: 6 Days

    Profile from plasma in terms of Cmax for AR882

  16. Apparent terminal half-life (t1/2) for AR882

    Time frame: 6 Days

    Profile from plasma in terms of t1/2 for AR882

  17. Amount excreted (Ae) into urine for AR882

    Time frame: 6 Days

    Profile from urine in terms of Ae for AR882

  18. Fractional Excretion (FEUA) for AR882

    Time frame: 6 Days

    Profile from urine in terms of FEUA for AR882

Secondary outcomes

  1. PD profile of a single dose of AR882

    Time frame: 6 Days

    Profile from serum uric acid concentrations over time

  2. PD profile of a single dose of AR882 in combination with allopurinol

    Time frame: 6 Days

    Profile from serum uric acid concentrations over time

  3. PD profile of a single dose of AR882 in combination with febuxostat

    Time frame: 6 Days

    Profile from serum uric acid concentrations over time

Sponsors and collaborators

Lead sponsor

Arthrosi Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 15, 2020
Registry last updated
Nov 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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