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OpenTrials
Completed

NCT Number: NCT04314986

Multiple Ascending Dose Study of AR882 in Healthy Adult Male Volunteers

A study to assess multiple ascending doses 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

  • 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

Treatment and study plan

Cohort 1: AR882 or placebo

Drug

AR882 or matching placebo administered once daily for 10 days

Cohort 2: AR882 or placebo

Drug

AR882 or matching placebo administered once daily for 10 days.

Cohort 3: AR882 or placebo

Drug

AR882 or matching placebo administered once daily for 10 days

Cohort 4: AR882 or placebo

Drug

AR882 or matching placebo administered once daily for 10 days

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

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

    Time frame: 15 Days

    Profile from plasma in terms of AUC following multiple doses of AR882

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

    Time frame: 15 Days

    Profile from plasma in terms of Tmax following multiple doses of AR882

  7. Maximum plasma concentration (Cmax) for AR882

    Time frame: 15 Days

    Profile from plasma in terms of Cmax following multiple doses of AR882

  8. 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

  9. Amount excreted (Ae) into urine for AR882

    Time frame: 15 Days

    Profile from urine in terms of Ae following multiple doses of AR882

  10. Fractional Excretion (FEUA) for AR882

    Time frame: 15 Days

    Profile from urine in terms of FEUA following multiple doses of AR882

Secondary outcomes

  1. PD profile following multiple doses of AR882

    Time frame: 15 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, Multiple Ascending 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
Mar 19, 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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