RDEA3170 AME Study

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT01910506

Run by

Ardea Biosciences, Inc.

People needed

8

Starts

2013-08-01

Expected to finish

2013-11-01

Last updated by the study team

2014-01-09

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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