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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

Tracking Information
First Submitted Date  ICMJE March 10, 2020
First Posted Date  ICMJE April 15, 2020
Last Update Posted Date November 16, 2020
Actual Study Start Date  ICMJE January 22, 2019
Actual Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 14, 2020)
  • To evaluate the safety profile of AR882 based on incidence of abnormal laboratory findings [ Time Frame: 8 Days ]
    Analysis of abnormal safety laboratory findings
  • Safety Analyses [ Time Frame: 8 Days ]
    ECG Heart Rate
  • Safety Analyses [ Time Frame: 8 Days ]
    ECG PR-Interval
  • Safety Analyses [ Time Frame: 8 Days ]
    ECG RR-Interval
  • Safety Analyses [ Time Frame: 8 Days ]
    ECG QRS-Interval
  • Safety Analyses [ Time Frame: 8 Days ]
    ECG QT-Interval
  • Safety Analyses [ Time Frame: 8 Days ]
    ECG QTc-Interval
  • Safety Analyses [ Time Frame: 8 Days ]
    Vital Sign - Systolic Blood Pressure
  • Safety Analyses [ Time Frame: 8 Days ]
    Vital Sign - Diastolic Blood Pressure
  • Safety Analyses [ Time Frame: 8 Days ]
    Vital Sign - Pulse Rate
  • Safety Analyses [ Time Frame: 8 Days ]
    Vital Sign - Body Temperature
  • Safety Analyses [ Time Frame: 8 Days ]
    Vital Sign - Respiratory Rate
  • Area under the curve (AUC) for plasma AR882 [ Time Frame: 6 Days ]
    Profile from plasma in terms of AUC for AR882
  • Time to maximum plasma concentration (Tmax) for AR882 [ Time Frame: 6 Days ]
    Profile from plasma in terms of Tmax for AR882
  • Maximum plasma concentration (Cmax) for AR882 [ Time Frame: 6 Days ]
    Profile from plasma in terms of Cmax for AR882
  • Apparent terminal half-life (t1/2) for AR882 [ Time Frame: 6 Days ]
    Profile from plasma in terms of t1/2 for AR882
  • Amount excreted (Ae) into urine for AR882 [ Time Frame: 6 Days ]
    Profile from urine in terms of Ae for AR882
  • Fractional Excretion (FEUA) for AR882 [ Time Frame: 6 Days ]
    Profile from urine in terms of FEUA for AR882
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2020)
  • PD profile of a single dose of AR882 [ Time Frame: 6 Days ]
    Profile from serum uric acid concentrations over time
  • PD profile of a single dose of AR882 in combination with allopurinol [ Time Frame: 6 Days ]
    Profile from serum uric acid concentrations over time
  • PD profile of a single dose of AR882 in combination with febuxostat [ Time Frame: 6 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 The Study is Designed to Evaluate Single Ascending Doses of AR882 in Healthy Adult Males
Official Title  ICMJE A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Rising Dose Study of AR882, a Potent Uricosuric Agent, in Healthy Adult Male Volunteers
Brief Summary A randomized, double-blind, placebo-controlled, single ascending dose study 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: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: AR882 (Dose A)
    Intervention: Drug: Cohort 1: AR882
  • Experimental: AR882 (Dose B)
    Interventions:
    • Drug: Cohort 2: AR882
    • Drug: Cohort 6: AR882 Food Effect
    • Drug: Cohort 8: AR882 in combination with allopurinol
    • Drug: Cohort 9: AR882 in combination with febuxostat
  • Experimental: AR882 (Dose C)
    Intervention: Drug: Cohort 3: AR882
  • Experimental: AR882 (Dose D)
    Intervention: Drug: Cohort 4: AR882
  • Experimental: AR882 (Dose E)
    Intervention: Drug: Cohort 5: AR882
  • Experimental: AR882 (Dose B) Solid Oral Formulation
    Intervention: Drug: Cohort 7: AR882 Solid Oral Formulation
  • Placebo Comparator: Placebo
    Interventions:
    • 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
  • Active Comparator: Allopurinol
    Intervention: Drug: Cohort 8: AR882 in combination with allopurinol
  • Active Comparator: Febuxostat
    Intervention: Drug: Cohort 9: AR882 in combination with febuxostat
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: April 14, 2020)
64
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 31, 2019
Actual Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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 NCT04347005
Other Study ID Numbers  ICMJE AR882-101
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
Plan to Share IPD: No
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