RDEA3170 AME Study

A Phase 1 Absorption, Metabolism and Excretion Study of [14C]RDEA3170 Orally Administered to Healthy Adult Male Subjects

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]RDEA3170 in healthy adult male subjects.

Inclusion Criteria:

• 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 Criteria:

• 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.