Mild, Moderate and Severe Renal Impairment Study

Ardea Biosciences

Status and phase: Completed; Phase 1

Conditions: Gout

Treatments: Drug: RDEA3170

Study type: Interventional

Funder types: Industry

Identifiers

NCT02219516

RDEA3170-108

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: Male

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 4 patient groups

Cohort 1: Mild renal impairment

Experimental group

Description:

RDEA3170 15 mg once daily fasted

Treatment:

Drug: RDEA3170

Cohort 2: Moderate renal impairment

Experimental group

Description:

RDEA3170 15 mg once daily fasted

Treatment:

Drug: RDEA3170

Cohort 3: Severe renal impairment

Experimental group

Description:

RDEA3170 15 mg once daily fasted

Treatment:

Drug: RDEA3170

Cohort 4: Control subjects with normal renal function

Experimental group

Description:

RDEA3170 15 mg once daily fasted

Treatment:

Drug: RDEA3170