This study will assess the absolute bioavailability of a single oral dose of lesinurad and evaluate the pharmacokinetic (PK) parameters of lesinurad and [14C]lesinurad in healthy adult male subjects.
Full Title of Study: “A Phase 1, Open-Label Study to Assess the Absolute Bioavailability of a Single Oral Dose of Lesinurad With Respect to an Intravenous Micro Tracer Dose of [14C]Lesinurad in Healthy Adult Male Subjects”
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Basic Science
- Masking: None (Open Label)
- Study Primary Completion Date: February 2014
In this study a single dose of lesinurad will be administered after an overnight fast followed by a single 15-minute infusion of a radiolabeled intravenous micro tracer dose of [14C]lesinurad to assess the in vivo performance of lesinurad.
- Drug: Lesinurad 400 mg
- Drug: [14C]lesinurad (100 μg per 10 mL)
Arms, Groups and Cohorts
- Experimental: Lesinurad and [14C]lesinurad
- Single oral dose of lesinurad and single infusion of [14C]lesinurad
Clinical Trial Outcome Measures
- Characteristics of bioavailability in terms of lesinurad Pharmacokinetics (PK) profile from plasma.
- Time Frame: Day 1 to Day 5
- PK profile in terms of maximum observed concentration (Cmax), time of occurrence of maximum observed concentration (Tmax), area under the concentration-time curve (AUC), apparent terminal half-life (t½), mean residence time (MRT), mean absorption time (MAT), and absolute bioavailability (F).
- PK profile of [14C]lesinurad from plasma
- Time Frame: Day 1 to Day 5
- PK profile in terms of Cmax, AUC, t½, MRT, total body clearance (CL), and volume of distribution at steady state (Vss).
- Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters
- Time Frame: 5 weeks
Participating in This Clinical Trial
- Subject has a body weight ≥ 50 kg (110 lbs) and body mass index ≥ 18 and ≤ 30 kg/m2.
- Subject is free of any clinically significant disease or medical condition, per the Investigator's judgment
- Subject has a history or suspicion of kidney stones.
- Subject has undergone major surgery within 3 months prior to Screening.
- Subject donated blood or experienced significant blood loss (>450 mL) within 12 weeks prior to Screening or gave a plasma donation within 4 weeks prior to Screening.
- Subject has inadequate venous access or unsuitable veins for repeated venipuncture.
- Subject does not have a normal or clinically acceptable physical examination, per the Investigator's judgment.
- Subject has clinically relevant abnormalities in blood pressure, heart rate, or body temperature, per the Investigator's judgment.
- Subject has Screening clinical safety laboratory parameters (serum chemistry, hematology, or urinalysis) that are outside the normal limits and are considered clinically significant by the Investigator.
- Subject has clinically relevant abnormalities in 12-lead electrocardiogram, per the Investigator's judgment.
- Subject has a Screening serum urate level > 7 mg/dL.
- Subject had radiation exposure that exceeds 5 mSv in the last 12 months or 10 mSv in the last 5 years. This includes radiation exposure from the present study or other clinical studies, including diagnostic X-rays and other medical exposures but excluding exposure to background radiation. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study.
Gender Eligibility: Male
Minimum Age: 18 Years
Maximum Age: 55 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- Ardea Biosciences, Inc.
- Provider of Information About this Clinical Study
- Overall Official(s)
- J. Hall, Study Director, Ardea Biosciences, Inc.
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