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RDEA3170 PK/PD Study

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ClinicalTrials.gov Identifier: NCT02608710
Recruitment Status : Completed
First Posted : November 20, 2015
Last Update Posted : September 2, 2016
Sponsor:
Information provided by (Responsible Party):
Ardea Biosciences, Inc.

Brief Summary:
The purpose of this study is to examine the pharmacokinetic and pharmacodynamic effect of RDEA3170 when given as single or multiple doses

Condition or disease Intervention/treatment Phase
Gout Drug: RDEA3170 4.5 mg Drug: RDEA3170 6 mg Drug: RDEA3170 12 mg Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase 1, Randomized, Open-Label Study in Healthy Adult Male Subjects to Assess the Pharmacokinetics and Pharmacodynamics of RDEA3170
Study Start Date : November 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Gout

Arm Intervention/treatment
Experimental: Single Dose
Single dose of RDEA3170 4.5 mg, RDEA3170 6 mg or RDEA3170 12 mg on Days 1, 5 and 9.
Drug: RDEA3170 4.5 mg
Drug: RDEA3170 6 mg
Drug: RDEA3170 12 mg
Experimental: Multiple Dose
RDEA3170 12 mg once daily (qd)
Drug: RDEA3170 12 mg
Experimental: Single Dose Food Effect
Since dose of RDEA3170 6 mg administered in fed or fasted state on Day 1 and Day 8.
Drug: RDEA3170 6 mg



Primary Outcome Measures :
  1. Maximum observed concentration (Cmax) [ Time Frame: Days -1, 1, 5 and 9 ]
    Single-dose Pharmacokinetic (PK) profile of RDEA3170 4.5 mg, 6 mg and 12 mg

  2. Cmax [ Time Frame: Days -1, 1 and 7 ]
    Multiple-dose Pharmacokinetic (PK) profile of RDEA3170 12 mg

  3. Cmax [ Time Frame: Days -1, 1, 7 and 8 ]
    Single-dose Pharmacokinetic (PK) profile of RDEA3170 6 mg under fed and fasted conditions

  4. Time of Occurrence of maximum observed concentration (Tmax) [ Time Frame: Days -1, 1, 5 and 9 ]
    Single-dose Pharmacokinetic (PK) profile of RDEA3170 4.5 mg, 6 mg and 12 mg

  5. Area under the plasma concentration time curve (AUC) [ Time Frame: Days -1, 1, 5 and 9 ]
    Single-dose Pharmacokinetic (PK) profile of RDEA3170 4.5 mg, 6 mg and 12 mg

  6. Tmax [ Time Frame: Days -1, 1 and 7 ]
    Multiple-dose Pharmacokinetic (PK) profile of RDEA3170 12 mg

  7. AUC [ Time Frame: Days -1, 1 and 7 ]
    Multiple-dose Pharmacokinetic (PK) profile of RDEA3170 12 mg

  8. Tmax [ Time Frame: Days -1, 1, 7 and 8 ]
    Single-dose Pharmacokinetic (PK) profile of RDEA3170 6 mg under fed and fasted conditions

  9. AUC [ Time Frame: Days -1, 1, 7 and 8 ]
    Single-dose Pharmacokinetic (PK) profile of RDEA3170 6 mg under fed and fasted conditions

  10. Serum urate concentration [ Time Frame: Days -1, 1, 5 and 9 ]
    Single-dose Pharmacodynamic (PD) profile of RDEA3170 4.5 mg, 6 mg and 12 mg

  11. Urine uric acid excretion amount [ Time Frame: Days -1, 1, 5 and 9 ]
    Single-dose Pharmacodynamic (PD) profile of RDEA3170 4.5 mg, 6 mg and 12 mg

  12. Renal clearance of uric acid [ Time Frame: Days -1, 1, 5 and 9 ]
    Single-dose Pharmacodynamic (PD) profile of RDEA3170 4.5 mg, 6 mg and 12 mg

  13. Fractional excretion of uric acid [ Time Frame: Days -1, 1, 5 and 9 ]
    Single-dose Pharmacodynamic (PD) profile of RDEA3170 4.5 mg, 6 mg and 12 mg

  14. Serum urate concentration [ Time Frame: Days -1, 1 and 7 ]
    Multiple-dose Pharmacodynamic (PD) profile of RDEA3170 12 mg

  15. Urine uric acid excretion amount [ Time Frame: Days -1, 1 and 7 ]
    Multiple-dose Pharmacodynamic (PD) profile of RDEA3170 12 mg

  16. Renal clearance of uric acid [ Time Frame: Days -1, 1 and 7 ]
    Multiple-dose Pharmacodynamic (PD) profile of RDEA3170 12 mg

  17. Fractional excretion of uric acid [ Time Frame: Days -1, 1 and 7 ]
    Multiple-dose Pharmacodynamic (PD) profile of RDEA3170 12 mg

  18. Serum urate concentration [ Time Frame: Days -1, 1, 7 and 8 ]
    Single-dose Pharmacodynamic (PD) profile of RDEA3170 6 mg under fed and fasted conditions

  19. Urine uric acid excretion amount [ Time Frame: Days -1, 1, 7 and 8 ]
    Single-dose Pharmacodynamic (PD) profile of RDEA3170 6 mg under fed and fasted conditions

  20. Renal Clearance of Uric Acid [ Time Frame: Days -1, 1, 7 and 8 ]
    Single-dose Pharmacodynamic (PD) profile of RDEA3170 6 mg under fed and fasted conditions

  21. Fractional excretion of uric acid [ Time Frame: Days -1, 1, 7 and 8 ]
    Single-dose Pharmacodynamic (PD) profile of RDEA3170 6 mg under fed and fasted conditions


Secondary Outcome Measures :
  1. Incidence of Adverse Events in terms of changes in laboratory parameters [ Time Frame: 6 weeks ]
  2. Incidence of Adverse Events in terms of electrocardiogram parameters [ Time Frame: 6 weeks ]
  3. Incidence of Adverse Events in terms of vital signs [ Time Frame: 6 weeks ]
  4. Incidence of Adverse Events in terms of physical examination findings [ Time Frame: 6 weeks ]
  5. Apparent terminal half-life (t1/2) [ Time Frame: Days -1, 1, 5 and 9 ]
    Single-dose Pharmacokinetic (PK) profile of RDEA3170 4.5 mg, 6 mg and 12 mg from plasma and urine

  6. t1/2 [ Time Frame: Days -1, 1, 7 and 8 ]
    Single-dose Pharmacokinetic (PK) profile of RDEA3170 6 mg under fed and fasted conditions

  7. t1/2 [ Time Frame: Days -1, 1 and 7 ]
    Multiple-dose Pharmacokinetic (PK) profile of RDEA3170 12 mg from plasma and urine



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:

  • Subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 40 kg/m2.
  • Subject has a Screening serum urate level 4 to 7 mg/dL
  • Subject is free of any clinically significant disease or medical condition, per the Investigator's judgment.

Exclusion Criteria:

  • Subject has a history or suspicion of kidney stones.
  • Subject has undergone major surgery within 3 months prior to Screening.
  • Subject donated blood or experienced significant blood loss within 12 weeks prior to Day 1 or gave a plasma donation within 4 weeks prior to Day 1.
  • Subject has clinically unacceptable physical examination, per the Investigator's judgment.
  • Subject has clinically relevant abnormalities in blood pressure, heart rate, or body temperature, per the Investigator's judgment.
  • Subject has Screening clinical safety laboratory parameters (serum chemistry [other than serum creatinine and serum urate], hematology, coagulation or urinalysis) that are outside the normal limits and are considered clinically significant by the Investigator.
  • Subject has a serum creatinine value above the upper limit of normal at the Screening visit.
  • Subject has clinically relevant abnormalities in 12-lead electrocardiogram, per the Investigator's judgment.
  • Subject has a history of cardiac abnormalities
  • Subject has received any strong or moderate enzyme-inducing drug or product within 2 months prior to Day 1.

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): NCT02608710


Locations
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United States, Texas
Austin, Texas, United States, 78744
Sponsors and Collaborators
Ardea Biosciences, Inc.
Investigators
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Study Director: J. Hall, MD Ardea Biosciences, Inc.

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Responsible Party: Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT02608710    
Other Study ID Numbers: RDEA3170-112
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: September 2, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Verinurad
Gout Suppressants
Antirheumatic Agents