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CompletedNCT01883167Updated Jan 9, 2014

RDEA3170 and Febuxostat Drug Interaction Study

A Phase 1 interventional study of RDEA3170 10 mg and Febuxostat 40 mg in Healthy, sponsored by Ardea Biosciences, Inc.. Completed at 1 site in United States. Open to male participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-01-09.

Sponsored by Ardea Biosciences, Inc. · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
21
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Male
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Study 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.

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Conditions studied

  • Healthy
03

In context

Lead sponsor

Ardea Biosciences, Inc. is the lead sponsor of 36 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
21 participants (actual)

Study arms

  • 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 · Drug: Febuxostat 40 mg · Drug: placebo

  • 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 · Drug: Febuxostat 40 mg · Drug: placebo

Interventions

  • DrugRDEA3170 10 mg

    RDEA3170 10 mg once daily (qd)

  • DrugFebuxostat 40 mg

    Febuxostat 40 mg qd

  • Drugplacebo

    placebo qd

06

What researchers measure

Primary outcomes

  1. PK profile of RDEA3170 from plasma and urine and febuxostat from plasma

    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

    Time frame: Days -1 (urine only), 7, 14, 21 and Days 8, 15, 22 (plasma only)

Secondary outcomes

  1. PD profile of RDEA3170 and febuxostat alone and in combination

    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

    Time frame: Days -1, 7, 14, 21 and Days 8, 15, 22 (serum only)

  2. Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters

    Time frame: 8 weeks

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Study locations

1 site
  • Kalamazoo, Michigan 49007, United States
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References and documents

Publications

  • Rekic D, Johansson S, Leander J. Higher Febuxostat Exposure Observed in Asian Compared with Caucasian Subjects Independent of Bodyweight. Clin Pharmacokinet. 2021 Mar;60(3):319-328. doi: 10.1007/s40262-020-00943-6. Epub 2020 Sep 19. PubMed 32951150 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01883167
Lead sponsor
Ardea Biosciences, Inc.
Responsible party
Sponsor
First posted
Jun 21, 2013
Start date
Jun 2013
Primary completion
Sep 2013
Completion
Dec 2013
Last update
Jan 9, 2014

Study contacts

S. Baumgartner
study director · Ardea Biosciences, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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