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Multiple Ascending Dose Study of AR882 in Healthy Adult Male Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04314986
Recruitment Status : Completed
First Posted : March 19, 2020
Last Update Posted : November 16, 2020
Sponsor:
Information provided by (Responsible Party):
Arthrosi Therapeutics

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

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Cohort 1: AR882 or placebo Drug: Cohort 2: AR882 or placebo Drug: Cohort 3: AR882 or placebo Drug: Cohort 4: AR882 or placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of AR882, a Potent Uricosuric Agent, in Healthy Adult Male Volunteers
Actual Study Start Date : June 28, 2019
Actual Primary Completion Date : September 18, 2019
Actual Study Completion Date : September 18, 2019

Arm Intervention/treatment
Experimental: AR882 (Dose A) Drug: Cohort 1: AR882 or placebo
AR882 or matching placebo administered once daily for 10 days

Experimental: AR882 (Dose B) Drug: Cohort 2: AR882 or placebo
AR882 or matching placebo administered once daily for 10 days.

Experimental: AR882 (Dose C) Drug: Cohort 3: AR882 or placebo
AR882 or matching placebo administered once daily for 10 days

Experimental: AR882 (Dose D) Drug: Cohort 4: AR882 or placebo
AR882 or matching placebo administered once daily for 10 days

Placebo Comparator: Placebo Drug: Cohort 1: AR882 or placebo
AR882 or matching placebo administered once daily for 10 days

Drug: Cohort 2: AR882 or placebo
AR882 or matching placebo administered once daily for 10 days.

Drug: Cohort 3: AR882 or placebo
AR882 or matching placebo administered once daily for 10 days

Drug: Cohort 4: AR882 or placebo
AR882 or matching placebo administered once daily for 10 days




Primary Outcome Measures :
  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 Outcome Measures :
  1. PD profile following multiple doses of AR882 [ Time Frame: 15 Days ]
    Profile from serum uric acid concentrations over time



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04314986


Locations
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Australia, Victoria
Nucleus Network Pty, Ltd.
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Arthrosi Therapeutics
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Responsible Party: Arthrosi Therapeutics
ClinicalTrials.gov Identifier: NCT04314986    
Other Study ID Numbers: AR882-102
First Posted: March 19, 2020    Key Record Dates
Last Update Posted: November 16, 2020
Last Verified: March 2020

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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