Bioavailability of Lesinurad and Intravenous [14C]Lesinurad



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 55
Updated:3/1/2014
Start Date:January 2014
End Date:May 2014
Contact:S. Szambelan
Phone:858.652.6563

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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

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.

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.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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.
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