Status:
COMPLETED
RDEA3170 AME Study
Lead Sponsor:
Ardea Biosciences, Inc.
Conditions:
Healthy
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
This study will determine the characteristics of absorption, metabolism, and excretion (AME) of RDEA3170 following a single 10 mg dose of RDEA3170 oral solution with 500 microcuries (µCi) of \[14 C\]R...
Eligibility Criteria
Inclusion
- Body weight ≥ 50 kg (110 lbs.) and body mass index ≥ 18 and ≤ 30 kg/m2.
- No clinically relevant abnormalities in vital signs, ECG, physical examination or safety laboratory values.
- Screening serum urate level ≤ 7.0 mg/dL.
- Subject has a minimum of 1 bowel movement a day.
Exclusion
- History or suspicion of kidney stones.
- History of gastrointestinal ulcers, Helicobacter pylori infection, or other disorders of gastric pH.
- History of previous surgery on the stomach or small intestine (appendectomy is acceptable). Subject has donated blood or experienced significant blood loss (\> 450 mL) within 12 weeks prior to Day 1 or has given a plasma donation within 6 weeks prior to Day 1.
- Inadequate venous access or unsuitable veins for repeated venipuncture.
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01910506
Start Date
August 1 2013
End Date
November 1 2013
Last Update
January 9 2014
Active Locations (1)
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1
Madison, Wisconsin, United States, 53704