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

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: NCT04347005
Recruitment Status : Completed
First Posted : April 15, 2020
Last Update Posted : November 16, 2020
Sponsor:
Information provided by (Responsible Party):
Arthrosi Therapeutics

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

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Cohort 1: AR882 Drug: Cohort 2: AR882 Drug: Cohort 3: AR882 Drug: Cohort 4: AR882 Drug: Cohort 5: AR882 Drug: Cohort 6: AR882 Food Effect Drug: Cohort 7: AR882 Solid Oral Formulation Drug: Cohort 8: AR882 in combination with allopurinol Drug: Cohort 9: AR882 in combination with febuxostat Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Rising Dose Study of AR882, a Potent Uricosuric Agent, in Healthy Adult Male Volunteers
Actual Study Start Date : January 22, 2019
Actual Primary Completion Date : July 31, 2019
Actual Study Completion Date : July 31, 2019

Arm Intervention/treatment
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

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 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 6: AR882 Food Effect
Single dose of AR882 or matching placebo in a fed state

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • 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

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): NCT04347005


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: NCT04347005    
Other Study ID Numbers: AR882-101
First Posted: April 15, 2020    Key Record Dates
Last Update Posted: November 16, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Allopurinol
Febuxostat
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs