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Completed

NCT Number: NCT02608710

RDEA3170 PK/PD Study

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

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RDEA3170 4.5 mg

Drug

RDEA3170 6 mg

Drug

RDEA3170 12 mg

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Ardea Biosciences, Inc.

Industry

Registry information

Official study title

A Phase 1, Randomized, Open-Label Study in Healthy Adult Male Subjects to Assess the Pharmacokinetics and Pharmacodynamics of RDEA3170

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Nov 20, 2015
Registry last updated
Sep 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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