Pharmacokinetic Study of AR882 in Subjects With Various Degrees of Renal Impairment

A Phase 1, Pharmacokinetic and Pharmacodynamic Study of AR882 in Adult Volunteers With Various Degrees of Renal Impairment

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04646889

Enrollment

Registered

2020-11-30

Start date

2021-01-14

Completion date

2022-06-27

Last updated

2022-08-05

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

Conditions

Renal Impairment

Brief summary

This is a 2-segment, multi-center, phase 1, open-label, study evaluating the pharmacokinetics and pharmacodynamics of AR882 in subjects with various degrees of renal impairment.

Interventions

DRUGAR882 Single Dose

A single dose of AR882

DRUGAR882 Multiple Dose

AR882 taken once daily for 14 days

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

Inclusion criteria

All Subjects: * Males and non-pregnant, non-lactating females * Body weight no less than 50 kg * sUA greater than or equal to 4.0 mg/dL Renal Impaired Subjects: • History of chronic renal impairment (\> 6 months)

Exclusion criteria

All Subjects: * Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin * History of cardiac abnormalities * Active peptic ulcer disease or active liver disease * History of kidney stones Renal Impaired Subjects: • Requires dialysis

Design outcomes

Primary

Measure	Time frame
t 1/2 following multiple doses of AR882 in subjects with renal impairment and normal renal function	15 days
Tmax following multiple doses of AR882 in subjects with renal impairment and normal renal function	15 days
Cmax following multiple doses of AR882 in subjects with renal impairment and normal renal function	15 days
Area under the curve (AUC) for plasma following a single dose of AR882 in subjects with renal impairment and normal renal function	6 days
Time to maximum plasma concentration (Tmax) following a single dose of AR882 in subjects with renal impairment and normal renal function	6 days
Maximum plasma concentration (Cmax) following a single dose of AR882 in subjects with renal impairment and normal renal function	6 days
Terminal half-life (t 1/2) following a single dose of AR882 in subjects with renal impairment and normal renal function	6 days
Amount excreted (Ae) into urine following a single dose of AR882 in subjects with renal impairment and normal renal function	6 days
Renal clearance (CLr) following a single dose of AR882 in subjects with renal impairment and normal renal function	6 days
AUC for plasma following multiple doses of AR882 in subjects with renal impairment and normal renal function	15 days

Secondary

Measure	Time frame
Incidence of Adverse Events, changes in laboratory, electrocardiogram, and vital signs following multiple doses of AR882 in subjects with renal impairment and normal renal function	21 days
Incidence of Adverse Events, changes in laboratory, electrocardiogram, and vital signs following a single dose of AR882 in subjects with renal impairment and normal renal function	14 days

Countries

New Zealand, United States

Outcome results

None listed

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