RDEA3170 AME Study
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: RDEA3170 10 mg
- Registration Number
- NCT01910506
- Lead Sponsor
- Ardea Biosciences, Inc.
- 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 \[14 C\]RDEA3170 in healthy adult male subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 8
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description RDEA3170 RDEA3170 10 mg -
- Primary Outcome Measures
Name Time Method Characteristics of AME in terms of pharmacokinetics (PK), metabolism, and excretion Day 1 predose, 15, 30, 45 mins, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 30, 36, 48, 54, 60, 72 hrs postdose (blood and plasma only); Day 1, -12 to 0, 0-6, 6-12, 12-24 hrs postdose (urine and feces only) PK profile in terms of AUC, Tmax, Cmax, t1/2, Ae, CLr, and CL/F.
AUC: area under the concentration-time curve; Tmax: time to reach maximum concentration; Cmax: maximum concentration; t1/2: apparent terminal half-life; Ae: amount of compound excreted in urine unchanged; CLr: renal clearance; CL/F: total body clearance corrected for bioavailability
Metabolic profile of RDEA3170 in plasma, urine, and feces.
Excretion in terms of recovery of radioactivity in urine and feces.
- Secondary Outcome Measures
Name Time Method Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters 5 weeks