Status:
COMPLETED
RDEA3170 and Febuxostat Drug Interaction Study
Lead Sponsor:
Ardea Biosciences, Inc.
Conditions:
Healthy
Eligibility:
MALE
18-65 years
Phase:
PHASE1
Brief 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 inform...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01883167
Start Date
June 1 2013
End Date
December 1 2013
Last Update
January 9 2014
Active Locations (1)
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1
Kalamazoo, Michigan, United States, 49007