FindTrial
Sign In

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04347005
Enrollment
64
Registered
2020-04-15
Start date
2019-01-22
Completion date
2019-07-31
Last updated
2020-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Brief summary

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

Interventions

DRUGCohort 1: AR882

Single dose of AR882 or matching placebo

DRUGCohort 2: AR882

Single dose of AR882 or matching placebo

DRUGCohort 3: AR882

Single dose of AR882 or matching placebo

DRUGCohort 4: AR882

Single dose of AR882 or matching placebo

DRUGCohort 5: AR882

Single dose of AR882 or matching placebo

DRUGCohort 6: AR882 Food Effect

Single dose of AR882 or matching placebo in a fed state

DRUGCohort 7: AR882 Solid Oral Formulation

Single dose of AR882 or matching placebo

DRUGCohort 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

DRUGCohort 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

Sponsors

Arthrosi Therapeutics
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Fractional Excretion (FEUA) for AR8826 DaysProfile from urine in terms of FEUA for AR882
Maximum plasma concentration (Cmax) for AR8826 DaysProfile from plasma in terms of Cmax for AR882
Apparent terminal half-life (t1/2) for AR8826 DaysProfile from plasma in terms of t1/2 for AR882
Amount excreted (Ae) into urine for AR8826 DaysProfile from urine in terms of Ae for AR882
To evaluate the safety profile of AR882 based on incidence of abnormal laboratory findings8 DaysAnalysis of abnormal safety laboratory findings
Safety Analyses8 DaysECG Heart Rate
Area under the curve (AUC) for plasma AR8826 DaysProfile from plasma in terms of AUC for AR882
Time to maximum plasma concentration (Tmax) for AR8826 DaysProfile from plasma in terms of Tmax for AR882

Secondary

MeasureTime frameDescription
PD profile of a single dose of AR882 in combination with allopurinol6 DaysProfile from serum uric acid concentrations over time
PD profile of a single dose of AR882 in combination with febuxostat6 DaysProfile from serum uric acid concentrations over time
PD profile of a single dose of AR8826 DaysProfile from serum uric acid concentrations over time

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026