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Mild, Moderate and Severe Renal Impairment Study

Primary Purpose

Gout

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

RDEA3170

About this trial

This is an interventional basic science trial for Gout

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Cohort 1: Mild renal impairment

Cohort 2: Moderate renal impairment

Cohort 3: Severe renal impairment

Cohort 4: Control subjects with normal renal function

Arm Description

RDEA3170 15 mg once daily fasted

Outcomes

Primary Outcome Measures

Maximum Observed Plasma Concentration (Cmax)

Cmax following a single administration of RDEA3170 to subjects with various degrees of renal function

Time of Occurrence of Maximum Observed Concentration (Tmax)

Tmax following a single administration of RDEA3170 to subjects with various degrees of renal function

Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)

AUC last following a single administration of RDEA3170 to subjects with various degrees of renal function

Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞)

AUC∞ following a single administration of RDEA3170 to subjects with various degrees of renal function

Apparent Terminal Half-life (t1/2)

t1/2 following a single administration of RDEA3170 to subjects with various degrees of renal function

Non-renal Clearance From Time 0 to 72 Hours Postdose (CLNR 0-72)

CLNR 0-72 following a single administration of RDEA3170 to subjects with various degrees of renal function

Total Body Clearance Corrected for Bioavailability (CL/F)

CL/F following a single administration of RDEA3170 to subjects with various degrees of renal function

Renal Clearance Time 0 to 72 Hours Postdose (CLR 0-72)

CLR 0-72 following a single administration of RDEA3170 to subjects with various degrees of renal function

Secondary Outcome Measures

Incidence of Treatment-Emergent Adverse Events

Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine

Full Information

NCT ID

NCT02219516

First Posted

August 15, 2014

Last Updated

March 14, 2017

Sponsor

Ardea Biosciences, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02219516

Brief Title

Mild, Moderate and Severe Renal Impairment Study

Official Title

A Phase 1, Single-Dose, Open Label, Pharmacokinetic and Pharmacodynamic Study of RDEA3170 in Adult Male Subjects With Mild, Moderate, and Severe Renal Impairment

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

August 1, 2014 (Actual)

Primary Completion Date

October 30, 2015 (Actual)

Study Completion Date

May 13, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ardea Biosciences, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gout

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1: Mild renal impairment

Arm Type

Experimental

Arm Description

RDEA3170 15 mg once daily fasted

Arm Title

Cohort 2: Moderate renal impairment

Arm Type

Experimental

Arm Description

RDEA3170 15 mg once daily fasted

Arm Title

Cohort 3: Severe renal impairment

Arm Type

Experimental

Arm Description

RDEA3170 15 mg once daily fasted

Arm Title

Cohort 4: Control subjects with normal renal function

Arm Type

Experimental

Arm Description

RDEA3170 15 mg once daily fasted

Intervention Type

Drug

Intervention Name(s)

RDEA3170

Primary Outcome Measure Information:

Title

Maximum Observed Plasma Concentration (Cmax)

Description

Cmax following a single administration of RDEA3170 to subjects with various degrees of renal function

Time Frame