Back to resultsRDEA3170 and Allopurinol Combination Study in Gout Subjects
Primary Purpose
Gout
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
RDEA3170 10 mg
allopurinol 300 mg
Sponsored by
About this trial
This is an interventional basic science trial for Gout
Eligibility Criteria
Inclusion Criteria:
- Subject meets one or more criteria for the diagnosis of gout as per the American Rheumatism Association Criteria for the Classification of Acute Arthritis of Primary Gout.
- Subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 45 kg/m2.
- Subject has a Screening serum urate level ≥ 8 mg/dL and ≤ 10 mg/dL
- Subject is free of any clinically significant disease or medical condition, per the Investigator's judgment.
Exclusion Criteria:
- Subject is unable to take colchicine for gout flare prophylaxis.
- Subject has a history or suspicion of kidney stones.
- Subject has an estimated creatinine clearance < 60 mL/min calculated by the Cockcroft-Gault formula using ideal body weight at Screening prior to Day -2.
- Subject is on unstable doses of chronic medications. Subjects taking medications for chronic medical conditions must be on stable doses during the course of the study, including the Screening period. Dose adjustments are allowed if deemed medically necessary by the investigator and following discussion with the medical monitor
- Chronic and stable doses of losartan, fenofibrate, guaifenesin, and sodium-glucose linked transporter-2 inhibitors are permitted if the dose is stable for at least 14 days prior to study medication dosing.
- Subject is unable or unwilling to comply with the study requirements or has a situation or condition that, in the opinion of the Investigator, may interfere with participation in the study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Sequence A
Sequence B
Arm Description
RDEA3170 qd (once daily), RDEA3170 + allopurinol qd, allopurinol qd
allopurinol qd, RDEA3170 + allopurinol qd, RDEA3170 qd
Outcomes
Primary Outcome Measures
Maximum Observed Plasma Concentration (Cmax)
Cmax of Allopurinol/Oxypurinol Alone and In Combination with RDEA3170
Time of Occurrence of Maximum Observed Concentration (Tmax)
Tmax of Allopurinol/Oxypurinol and RDEA3170 Alone and In Combination
Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)
AUC 0-24 of Allopurinol/Oxypurinol Alone and In Combination with RDEA3170
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)
AUC last of Allopurinol/Oxypurinol Alone and In Combination with RDEA3170
Apparent Terminal Half-life (t1/2)
t1/2 of Allopurinol/Oxypurinol and RDEA3170 Alone and In Combination
Amount Excreted in Urine as Unchanged Drug or Metabolite (Ae0-24)
Ae0-24 of Allopurinol/Oxypurinol Alone and In Combination with RDEA3170
Renal Clearance of the Drug From Time Zero up to 24 Hours Postdose (CRL0-24)
CLR0-24 of Allopurinol/Oxypurinol and RDEA3170 Alone and In Combination
Pharmacodynamics (PD) Profile of Uric Acid From Serum and Urine
Maximum Observed Plasma Concentration (Cmax)
Cmax of RDEA3170 Alone and In Combination with Allopurinol
Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)
AUC 0-24 of RDEA3170 Alone and In Combination with Allopurinol
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)
AUC last of RDEA3170 Alone and In Combination with Allopurinol
Amount Excreted in Urine as Unchanged Drug or Metabolite (Ae0-24)
Ae0-24 of RDEA3170 Alone and In Combination with Allopurinol
Secondary Outcome Measures
Incidence of Treatment-Emergent Adverse Events
Full Information
NCT ID
NCT02279641
First Posted
October 28, 2014
Last Updated
December 19, 2017
Sponsor
Ardea Biosciences, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02279641
Brief Title
RDEA3170 and Allopurinol Combination Study in Gout Subjects
Official Title
A Phase 1b, Randomized, Open-label Study to Evaluate the Potential Pharmacokinetic and Pharmacodynamic Interactions Between RDEA3170 and Allopurinol in Adult Male Subjects With Gout
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
November 1, 2014 (Actual)
Primary Completion Date
April 6, 2015 (Actual)
Study Completion Date
September 11, 2015 (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 1b, randomized, open-label, drug-drug interaction study in adult male subjects with gout. It is designed to assess the pharmacokinetics (PK) and pharmacodynamics (PD) of RDEA3170 or allopurinol alone and in combination in the fed state.
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
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sequence A
Arm Type
Experimental
Arm Description
RDEA3170 qd (once daily), RDEA3170 + allopurinol qd, allopurinol qd
Arm Title
Sequence B
Arm Type
Experimental
Arm Description
allopurinol qd, RDEA3170 + allopurinol qd, RDEA3170 qd
Intervention Type
Drug
Intervention Name(s)
RDEA3170 10 mg
Intervention Type
Drug
Intervention Name(s)
allopurinol 300 mg
Primary Outcome Measure Information:
Title
Maximum Observed Plasma Concentration (Cmax)
Description
Cmax of Allopurinol/Oxypurinol Alone and In Combination with RDEA3170
Time Frame
22 days
Title
Time of Occurrence of Maximum Observed Concentration (Tmax)
Description
Tmax of Allopurinol/Oxypurinol and RDEA3170 Alone and In Combination
Time Frame
22 days
Title
Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)
Description
AUC 0-24 of Allopurinol/Oxypurinol Alone and In Combination with RDEA3170
Time Frame
22 days
Title
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)
Description
AUC last of Allopurinol/Oxypurinol Alone and In Combination with RDEA3170
Time Frame
22 days
Title
Apparent Terminal Half-life (t1/2)
Description
t1/2 of Allopurinol/Oxypurinol and RDEA3170 Alone and In Combination
Time Frame
22 days
Title
Amount Excreted in Urine as Unchanged Drug or Metabolite (Ae0-24)
Description
Ae0-24 of Allopurinol/Oxypurinol Alone and In Combination with RDEA3170
Time Frame
22 days
Title
Renal Clearance of the Drug From Time Zero up to 24 Hours Postdose (CRL0-24)
Description
CLR0-24 of Allopurinol/Oxypurinol and RDEA3170 Alone and In Combination
Time Frame
22 days
Title
Pharmacodynamics (PD) Profile of Uric Acid From Serum and Urine
Time Frame
22 days
Title
Maximum Observed Plasma Concentration (Cmax)
Description
Cmax of RDEA3170 Alone and In Combination with Allopurinol
Time Frame
22 days
Title
Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)
Description
AUC 0-24 of RDEA3170 Alone and In Combination with Allopurinol
Time Frame
22 days
Title
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)
Description
AUC last of RDEA3170 Alone and In Combination with Allopurinol
Time Frame
22 days
Title
Amount Excreted in Urine as Unchanged Drug or Metabolite (Ae0-24)
Description
Ae0-24 of RDEA3170 Alone and In Combination with Allopurinol
Time Frame
22 days
Secondary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events
Time Frame
22 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject meets one or more criteria for the diagnosis of gout as per the American Rheumatism Association Criteria for the Classification of Acute Arthritis of Primary Gout.
Subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 45 kg/m2.
Subject has a Screening serum urate level ≥ 8 mg/dL and ≤ 10 mg/dL
Subject is free of any clinically significant disease or medical condition, per the Investigator's judgment.
Exclusion Criteria:
Subject is unable to take colchicine for gout flare prophylaxis.
Subject has a history or suspicion of kidney stones.
Subject has an estimated creatinine clearance < 60 mL/min calculated by the Cockcroft-Gault formula using ideal body weight at Screening prior to Day -2.
Subject is on unstable doses of chronic medications. Subjects taking medications for chronic medical conditions must be on stable doses during the course of the study, including the Screening period. Dose adjustments are allowed if deemed medically necessary by the investigator and following discussion with the medical monitor
Chronic and stable doses of losartan, fenofibrate, guaifenesin, and sodium-glucose linked transporter-2 inhibitors are permitted if the dose is stable for at least 14 days prior to study medication dosing.
Subject is unable or unwilling to comply with the study requirements or has a situation or condition that, in the opinion of the Investigator, may interfere with participation in the study.
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
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
12. IPD Sharing Statement
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RDEA3170 and Allopurinol Combination Study in Gout Subjects
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