Trial | NCT04347005  Report issue

Title

The Study is Designed to Evaluate Single Ascending Doses of AR882 in Healthy Adult Males
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Rising Dose Study of AR882, a Potent Uricosuric Agent, in Healthy Adult Male Volunteers

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    64
A randomized, double-blind, placebo-controlled, single ascending dose study of AR882 in healthy adult males.
Study Started
Jan 22
2019
Primary Completion
Jul 31
2019
Study Completion
Jul 31
2019
Last Update
Nov 16
2020

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 1: 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 [ar882, allopurinol (zyloprim)]

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 [ar882, febuxostat (uloric)]

Single dose of febuxostat alone and a single dose of AR882 in combination with a single dose of febuxostat

AR882 (Dose A) Experimental

AR882 (Dose B) Experimental

AR882 (Dose C) Experimental

AR882 (Dose D) Experimental

AR882 (Dose E) Experimental

AR882 (Dose B) Solid Oral Formulation Experimental

Placebo Placebo Comparator

Allopurinol Active Comparator

Febuxostat Active Comparator

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
No Results Posted