Mild, Moderate and Severe Renal Impairment Study
Primary Purpose
Gout
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
RDEA3170
Sponsored by
![Ardea Biosciences, Inc.](https://trials-media.s3.amazonaws.com/orgs/ardea-biosciences-inc.jpeg)
About this trial
This is an interventional basic science trial for Gout
Eligibility Criteria
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
Experimental
Experimental
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
RDEA3170 15 mg once daily fasted
RDEA3170 15 mg once daily fasted
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
No
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
Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose
Title
Time of Occurrence of Maximum Observed Concentration (Tmax)
Description
Tmax following a single administration of RDEA3170 to subjects with various degrees of renal function
Time Frame
Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose
Title
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)
Description
AUC last following a single administration of RDEA3170 to subjects with various degrees of renal function
Time Frame
Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose
Title
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞)
Description
AUC∞ following a single administration of RDEA3170 to subjects with various degrees of renal function
Time Frame
Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose
Title
Apparent Terminal Half-life (t1/2)
Description
t1/2 following a single administration of RDEA3170 to subjects with various degrees of renal function
Time Frame
Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose
Title
Non-renal Clearance From Time 0 to 72 Hours Postdose (CLNR 0-72)
Description
CLNR 0-72 following a single administration of RDEA3170 to subjects with various degrees of renal function
Time Frame
Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose
Title
Total Body Clearance Corrected for Bioavailability (CL/F)
Description
CL/F following a single administration of RDEA3170 to subjects with various degrees of renal function
Time Frame
Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose
Title
Renal Clearance Time 0 to 72 Hours Postdose (CLR 0-72)
Description
CLR 0-72 following a single administration of RDEA3170 to subjects with various degrees of renal function
Time Frame
Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose
Secondary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events
Time Frame
5 weeks
Title
Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine
Time Frame
Screening, Day -1 ( -24, -21, -18, -and -12 hours predose), and Day 1 (within 30 minutes prior to dosing and at 3, 6, 12, 24, 30, 36, 48, 54, 60, and 72 hours postdose)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. Hall, MD
Organizational Affiliation
Ardea Biosciences, Inc.
Official's Role
Study Director
Facility Information:
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29949102
Citation
Smith WB, Hall J, Berg JK, Kazimir M, Yamamoto A, Walker S, Lee CA, Shen Z, Wilson DM, Zhou D, Gillen M, Marbury TC. Effect of Renal Impairment on the Pharmacokinetics and Pharmacodynamics of Verinurad, a Selective Uric Acid Reabsorption Inhibitor. Clin Drug Investig. 2018 Aug;38(8):703-713. doi: 10.1007/s40261-018-0652-2.
Results Reference
derived
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Mild, Moderate and Severe Renal Impairment Study
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