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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

Tracking Information
First Submitted Date  ICMJE March 10, 2020
First Posted Date  ICMJE March 19, 2020
Last Update Posted Date November 16, 2020
Actual Study Start Date  ICMJE June 28, 2019
Actual Primary Completion Date September 18, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 17, 2020)
  • 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
  • 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
  • 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
  • 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
  • Area under the curve (AUC) for plasma AR882 [ Time Frame: 15 Days ]
    Profile from plasma in terms of AUC following multiple doses of AR882
  • Time to maximum plasma concentration (Tmax) for AR882 [ Time Frame: 15 Days ]
    Profile from plasma in terms of Tmax following multiple doses of AR882
  • Maximum plasma concentration (Cmax) for AR882 [ Time Frame: 15 Days ]
    Profile from plasma in terms of Cmax following multiple doses of AR882
  • 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
  • Amount excreted (Ae) into urine for AR882 [ Time Frame: 15 Days ]
    Profile from urine in terms of Ae following multiple doses of AR882
  • Fractional Excretion (FEUA) for AR882 [ Time Frame: 15 Days ]
    Profile from urine in terms of FEUA following multiple doses of AR882
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2020)
PD profile following multiple doses of AR882 [ Time Frame: 15 Days ]
Profile from serum uric acid concentrations over time
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multiple Ascending Dose Study of AR882 in Healthy Adult Male Volunteers
Official Title  ICMJE A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of AR882, a Potent Uricosuric Agent, in Healthy Adult Male Volunteers
Brief Summary A study to assess multiple ascending doses of AR882 in healthy adult males.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: AR882 (Dose A)
    Intervention: Drug: Cohort 1: AR882 or placebo
  • Experimental: AR882 (Dose B)
    Intervention: Drug: Cohort 2: AR882 or placebo
  • Experimental: AR882 (Dose C)
    Intervention: Drug: Cohort 3: AR882 or placebo
  • Experimental: AR882 (Dose D)
    Intervention: Drug: Cohort 4: AR882 or placebo
  • Placebo Comparator: Placebo
    Interventions:
    • Drug: Cohort 1: AR882 or placebo
    • Drug: Cohort 2: AR882 or placebo
    • Drug: Cohort 3: AR882 or placebo
    • Drug: Cohort 4: AR882 or placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 17, 2020)
30
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 18, 2019
Actual Primary Completion Date September 18, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04314986
Other Study ID Numbers  ICMJE AR882-102
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Arthrosi Therapeutics
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Arthrosi Therapeutics
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Arthrosi Therapeutics
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP