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Completed

NCT Number: NCT01883167

RDEA3170 and Febuxostat Drug Interaction Study

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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Kalamazoo, Michigan, 49007, United States

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

RDEA3170 10 mg

Drug

RDEA3170 10 mg once daily (qd)

Febuxostat 40 mg

Drug

Febuxostat 40 mg qd

Placebo

Drug

placebo qd

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Ardea Biosciences, Inc.

Industry

Registry information

Official study title

A Phase 1 Study to Evaluate the Potential Pharmacokinetic and Pharmacodynamic Interactions Between RDEA3170 and Febuxostat in Healthy Adult Male Subjects

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jun 21, 2013
Registry last updated
Jan 9, 2014

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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