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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-14

Study Completion Date

2022-06-27

Brief Summary

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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.

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Detailed Description

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Conditions

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Renal Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Renal Impairment

Subjects with various degrees of renal impairment

Group Type EXPERIMENTAL

AR882 Single Dose

Intervention Type DRUG

A single dose of AR882

AR882 Multiple Dose

Intervention Type DRUG

AR882 taken once daily for 14 days

Normal Renal Function

Subjects with normal renal function

Group Type EXPERIMENTAL

AR882 Single Dose

Intervention Type DRUG

A single dose of AR882

AR882 Multiple Dose

Intervention Type DRUG

AR882 taken once daily for 14 days

Interventions

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AR882 Single Dose

A single dose of AR882

Intervention Type DRUG

AR882 Multiple Dose

AR882 taken once daily for 14 days

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes