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History of Changes for Study: NCT04347005
The Study is Designed to Evaluate Single Ascending Doses of AR882 in Healthy Adult Males
Latest version (submitted November 12, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 14, 2020 None (earliest Version on record)
2 November 12, 2020 Conditions and Study Status
Comparison Format:

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Study NCT04347005
Submitted Date:  April 14, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: AR882-101
Brief Title: The Study is Designed to Evaluate Single Ascending Doses of AR882 in Healthy Adult Males
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
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2020
Overall Status: Completed
Study Start: January 22, 2019
Primary Completion: July 31, 2019 [Actual]
Study Completion: July 31, 2019 [Actual]
First Submitted: March 10, 2020
First Submitted that
Met QC Criteria:
April 14, 2020
First Posted: April 15, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
April 14, 2020
Last Update Posted: April 15, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Arthrosi Therapeutics
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief Summary: A randomized, double-blind, placebo-controlled, single ascending dose study of AR882 in healthy adult males.
Detailed Description:
Open or close this module Conditions
Conditions: Gout
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Parallel Assignment
Number of Arms: 9
Masking: Triple (Participant, Care Provider, Investigator)
Allocation: Randomized
Enrollment: 64 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 55 Years
Sex: Male
Gender Based:
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
Open or close this module Contacts/Locations
Locations: Australia, Victoria
Nucleus Network Pty, Ltd.
Melbourne, Victoria, Australia, 3004
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services