RDEA3170 and Febuxostat Drug Interaction Study

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT01883167

Run by

Ardea Biosciences, Inc.

People needed

21

Starts

2013-06-01

Expected to finish

2013-12-01

Last updated by the study team

2014-01-09

Who can join

Age: 18 and older, up to 65. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Kalamazoo, Michigan, United States

Full record on ClinicalTrials.gov

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