RDEA3170 AME Study
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 10/3/2013 |
| Start Date: | August 2013 |
| End Date: | November 2013 |
| Contact: | C. Winnett |
| Phone: | 858.652.6649 |
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.
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