NCT04347005

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Arthrosi Therapeutics · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-01-22
• Primary completion: 2019-07-31
• Completion: 2019-07-31
• First posted: 2020-04-15
• Last updated: 2020-11-16

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study