Status:
COMPLETED
Lesinurad Interaction Study With Ranitidine
Lead Sponsor:
Ardea Biosciences, Inc.
Conditions:
Healthy
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
This is a drug-drug interaction study in healthy volunteers to evaluate the potential pharmacokinetic (PK) effects of ranitidine on lesinurad.
Detailed Description
This study will evaluate the potential effect of ranitidine on the pharmacokinetics of lesinurad. An earlier study demonstrated an effect on lesinurad PK in the presence of both calcium-containing and...
Eligibility Criteria
Inclusion
- body weight ≥ 50 kg (110 lbs) and body mass index ≥ 18 and ≤ 30 kg/m2.
- Screening sUA value ≤ 7.0 mg/dL.
- free of any clinically significant disease that requires a physician's care and/or would interfere with study evaluations or procedures.
- Subject has no clinically relevant abnormalties in vital signs, ECG, physical examination or safety laboratory values per the Investigator's judgment.
Exclusion
- history or clinical manifestations of significant metabolic, hematological, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic renal,urological, or psychiatric disorders.
- history or suspicion of kidney stones.
- 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 visit.
- inadequate venous access or unsuitable veins for repeated venipuncture.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01908257
Start Date
July 1 2013
End Date
November 1 2013
Last Update
January 9 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cypress, California, United States, 90630