RDEA3170 AME Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: RDEA3170 10 mg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RDEA3170<br> | Drug: RDEA3170 10 mg<br> <br> * Other names: RDEA3170 10 mg dose oral solution with 500 μCi of [14C]RDEA3170;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characteristics of AME in terms of pharmacokinetics (PK), metabolism, and excretion | 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. | 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters |  | 5 weeks |