Mild, Moderate and Severe Renal Impairment Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-01

Study Completion Date

2016-05-13

Brief Summary

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This is a Phase 1, single-dose, open-label, pharmacokinetic (PK) and pharmacodynamic (PD) study of RDEA3170 in adult male subjects with mild, moderate, and severe renal impairment.

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Detailed Description

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Conditions

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Gout

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Cohort 1: Mild renal impairment

RDEA3170 15 mg once daily fasted

Group Type EXPERIMENTAL

RDEA3170

Intervention Type DRUG

Cohort 2: Moderate renal impairment

RDEA3170 15 mg once daily fasted

Group Type EXPERIMENTAL

RDEA3170

Intervention Type DRUG

Cohort 3: Severe renal impairment

RDEA3170 15 mg once daily fasted

Group Type EXPERIMENTAL

RDEA3170

Intervention Type DRUG

Cohort 4: Control subjects with normal renal function

RDEA3170 15 mg once daily fasted

Group Type EXPERIMENTAL

RDEA3170

Intervention Type DRUG

Interventions

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RDEA3170

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 40 kg/m2.
* Subject with renal impairment, as determined at Screening, with creatinine clearance as calculated by the Cockcroft-Gault formula of 60 to \< 90 mL/min (mild impairment), 30 to \< 60 mL/min (moderate impairment), or 15 to \< 30 mL/min (severe impairment), or a matched control subject (by age and body mass index) with a creatinine clearance of ≥ 90 mL/min.
* Subject has a Screening serum urate level ≥ 4.5 mg/dL and ≤ 10 mg/dL

Exclusion Criteria

* Subject has a history or clinical manifestations of significant metabolic, hematological, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urological, or psychiatric disorders.
* Subject has a history or suspicion of kidney stones.
* Subject has a history of asthma.
* Subject has undergone major surgery within 3 months prior to Day 1.
* Subject has donated blood or experienced significant blood loss (\> 450 mL) within 12 weeks prior to Day 1 or gave a plasma donation

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No