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Mild, Moderate and Severe Renal Impairment Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02219516
Recruitment Status : Completed
First Posted : August 19, 2014
Results First Posted : April 25, 2017
Last Update Posted : April 25, 2017
Sponsor:
Information provided by (Responsible Party):
Ardea Biosciences, Inc.

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.

Condition or disease Intervention/treatment Phase
Gout Drug: RDEA3170 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Actual Study Start Date : August 1, 2014
Actual Primary Completion Date : October 30, 2015
Actual Study Completion Date : May 13, 2016

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Gout

Arm Intervention/treatment
Experimental: Cohort 1: Mild renal impairment
RDEA3170 15 mg once daily fasted
Drug: RDEA3170
Experimental: Cohort 2: Moderate renal impairment
RDEA3170 15 mg once daily fasted
Drug: RDEA3170
Experimental: Cohort 3: Severe renal impairment
RDEA3170 15 mg once daily fasted
Drug: RDEA3170
Experimental: Cohort 4: Control subjects with normal renal function
RDEA3170 15 mg once daily fasted
Drug: RDEA3170



Primary Outcome Measures :
  1. Maximum Observed Plasma Concentration (Cmax) [ 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 ]
    Cmax following a single administration of RDEA3170 to subjects with various degrees of renal function

  2. Time of Occurrence of Maximum Observed Concentration (Tmax) [ 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 ]
    Tmax following a single administration of RDEA3170 to subjects with various degrees of renal function

  3. Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last) [ 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 ]
    AUC last following a single administration of RDEA3170 to subjects with various degrees of renal function

  4. Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞) [ 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 ]
    AUC∞ following a single administration of RDEA3170 to subjects with various degrees of renal function

  5. Apparent Terminal Half-life (t1/2) [ 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 ]
    t1/2 following a single administration of RDEA3170 to subjects with various degrees of renal function

  6. Non-renal Clearance From Time 0 to 72 Hours Postdose (CLNR 0-72) [ 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 ]
    CLNR 0-72 following a single administration of RDEA3170 to subjects with various degrees of renal function

  7. Total Body Clearance Corrected for Bioavailability (CL/F) [ 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 ]
    CL/F following a single administration of RDEA3170 to subjects with various degrees of renal function

  8. Renal Clearance Time 0 to 72 Hours Postdose (CLR 0-72) [ 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 ]
    CLR 0-72 following a single administration of RDEA3170 to subjects with various degrees of renal function


Secondary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [ Time Frame: 5 weeks ]
  2. 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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02219516


Locations
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United States, Colorado
Lakewood, Colorado, United States, 80228
United States, Florida
Orlando, Florida, United States, 32809
United States, Minnesota
Minneapolis, Minnesota, United States, 55404
United States, Tennessee
Knoxville, Tennessee, United States, 37920
Sponsors and Collaborators
Ardea Biosciences, Inc.
Investigators
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Study Director: J. Hall, MD Ardea Biosciences, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT02219516    
Other Study ID Numbers: RDEA3170-108
First Posted: August 19, 2014    Key Record Dates
Results First Posted: April 25, 2017
Last Update Posted: April 25, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases
Verinurad
Gout Suppressants
Antirheumatic Agents