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
1 other identifier
interventional
64
1 country
1
Brief Summary
A randomized, double-blind, placebo-controlled, single ascending dose study of AR882 in healthy adult males.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy-volunteers
Started Jan 2019
Typical duration for phase_1 healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2019
CompletedFirst Submitted
Initial submission to the registry
March 10, 2020
CompletedFirst Posted
Study publicly available on registry
April 15, 2020
CompletedNovember 16, 2020
March 1, 2020
6 months
March 10, 2020
November 12, 2020
Conditions
Outcome Measures
Primary Outcomes (18)
To evaluate the safety profile of AR882 based on incidence of abnormal laboratory findings
Analysis of abnormal safety laboratory findings
8 Days
Safety Analyses
ECG Heart Rate
8 Days
Safety Analyses
ECG PR-Interval
8 Days
Safety Analyses
ECG RR-Interval
8 Days
Safety Analyses
ECG QRS-Interval
8 Days
Safety Analyses
ECG QT-Interval
8 Days
Safety Analyses
ECG QTc-Interval
8 Days
Safety Analyses
Vital Sign - Systolic Blood Pressure
8 Days
Safety Analyses
Vital Sign - Diastolic Blood Pressure
8 Days
Safety Analyses
Vital Sign - Pulse Rate
8 Days
Safety Analyses
Vital Sign - Body Temperature
8 Days
Safety Analyses
Vital Sign - Respiratory Rate
8 Days
Area under the curve (AUC) for plasma AR882
Profile from plasma in terms of AUC for AR882
6 Days
Time to maximum plasma concentration (Tmax) for AR882
Profile from plasma in terms of Tmax for AR882
6 Days
Maximum plasma concentration (Cmax) for AR882
Profile from plasma in terms of Cmax for AR882
6 Days
Apparent terminal half-life (t1/2) for AR882
Profile from plasma in terms of t1/2 for AR882
6 Days
Amount excreted (Ae) into urine for AR882
Profile from urine in terms of Ae for AR882
6 Days
Fractional Excretion (FEUA) for AR882
Profile from urine in terms of FEUA for AR882
6 Days
Secondary Outcomes (3)
PD profile of a single dose of AR882
6 Days
PD profile of a single dose of AR882 in combination with allopurinol
6 Days
PD profile of a single dose of AR882 in combination with febuxostat
6 Days
Study Arms (9)
AR882 (Dose A)
EXPERIMENTALAR882 (Dose B)
EXPERIMENTALAR882 (Dose C)
EXPERIMENTALAR882 (Dose D)
EXPERIMENTALAR882 (Dose E)
EXPERIMENTALAR882 (Dose B) Solid Oral Formulation
EXPERIMENTALPlacebo
PLACEBO COMPARATORAllopurinol
ACTIVE COMPARATORFebuxostat
ACTIVE COMPARATORInterventions
Single dose of AR882 or matching placebo in a fed state
Single dose of AR882 or matching placebo
Single dose of allopurinol alone and a single dose of AR882 in combination with a single dose of allopurinol
Single dose of febuxostat alone and a single dose of AR882 in combination with a single dose of febuxostat
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nucleus Network Pty, Ltd.
Melbourne, Victoria, 3004, Australia
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2020
First Posted
April 15, 2020
Study Start
January 22, 2019
Primary Completion
July 31, 2019
Study Completion
July 31, 2019
Last Updated
November 16, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share