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RDEA3170 and Febuxostat Drug Interaction 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: NCT01883167
Recruitment Status : Completed
First Posted : June 21, 2013
Last Update Posted : January 9, 2014
Sponsor:
Information provided by (Responsible Party):
Ardea Biosciences, Inc.

Brief Summary:
This study will evaluate the potential pharmacokinetic (PK) and pharmacodynamic (PD) interaction between the XO inhibitor febuxostat and the investigational URAT1 inhibitor RDEA3170 and provide information for potential future clinical studies using this combination. Combination treatment using 2 drugs with different mechanisms of action may achieve improved response and may allow the use of lower doses, resulting in fewer side effects than the use of either drug alone.

Condition or disease Intervention/treatment Phase
Healthy Drug: RDEA3170 10 mg Drug: Febuxostat 40 mg Drug: placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Phase 1 Study to Evaluate the Potential Pharmacokinetic and Pharmacodynamic Interactions Between RDEA3170 and Febuxostat in Healthy Adult Male Subjects
Study Start Date : June 2013
Actual Primary Completion Date : September 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
Drug Information available for: Febuxostat

Arm Intervention/treatment
Experimental: Febuxostat

Days 1-7: febuxostat 40 mg qd. Days 8-14: RDEA3170 10 mg or placebo qd in combination with febuxostat 40 mg qd.

Days 15-21: RDEA3170 10 mg or placebo qd.

Drug: RDEA3170 10 mg
RDEA3170 10 mg once daily (qd)

Drug: Febuxostat 40 mg
Febuxostat 40 mg qd

Drug: placebo
placebo qd

Experimental: RDEA3170

Days 1-7: RDEA3170 10 mg or placebo qd. Days 8-14: RDEA3170 10 mg or placebo qd in combination with febuxostat 40 mg qd.

Days 15-21: febuxostat 40 mg qd.

Drug: RDEA3170 10 mg
RDEA3170 10 mg once daily (qd)

Drug: Febuxostat 40 mg
Febuxostat 40 mg qd

Drug: placebo
placebo qd




Primary Outcome Measures :
  1. PK profile of RDEA3170 from plasma and urine and febuxostat from plasma [ Time Frame: Days -1 (urine only), 7, 14, 21 and Days 8, 15, 22 (plasma only) ]

    Profile from plasma and urine in terms of AUC, Tmax, Cmax, t1/2, Ae, and CLr

    AUC: area under the concentration-time curve; Tmax: time to maximum plasma concentration; Cmax: maximum plasma drug concentration; t1/2: apparent terminal half-life; Ae: amount excreted of unchanged drug into urine; CLr: renal clearance



Secondary Outcome Measures :
  1. PD profile of RDEA3170 and febuxostat alone and in combination [ Time Frame: Days -1, 7, 14, 21 and Days 8, 15, 22 (serum only) ]

    Profile from serum and urine in terms of sUA concentration, renal clearance of uric acid, urine uric acid excretion amounts, and fractional excretion of uric acid.

    sUA: serum urate


  2. Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 40 kg/m2.
  • no clinically relevant abnormalities in vital signs, ECG, physical examination or safety laboratory values, per the Investigator's judgment.
  • a screening serum urate level ≥ 4.5 mg/dL.

Exclusion Criteria:

  • history or suspicion of kidney stones.
  • history of cardiac abnormalities as assessed during screening, including abnormal and clinically relevant electrocardiogram changes and/or family history of sudden death in otherwise healthy individual between the ages of 1 and 30 years.
  • undergone major surgery within 3 months prior to Day 1.
  • donated blood or experienced significant blood loss (> 450 mL) within 12 weeks prior to Day 1 or gave a plasma donation within 4 weeks prior to the Screening Period.
  • inadequate venous access or unsuitable veins for repeated venipuncture.

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): NCT01883167


Locations
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United States, Michigan
Kalamazoo, Michigan, United States, 49007
Sponsors and Collaborators
Ardea Biosciences, Inc.
Investigators
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Study Director: S. Baumgartner Ardea Biosciences, Inc.
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Responsible Party: Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT01883167    
Other Study ID Numbers: RDEA3170-105
First Posted: June 21, 2013    Key Record Dates
Last Update Posted: January 9, 2014
Last Verified: January 2014
Additional relevant MeSH terms:
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Febuxostat
Verinurad
Gout Suppressants
Antirheumatic Agents