Bioavailability of Lesinurad and Intravenous [14C]Lesinurad

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ardea Biosciences, Inc.
• Treatments: Lesinurad

Criteria

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.