Bioavailability of Lesinurad and Intravenous [14C]Lesinurad

Ardea Biosciences

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: [14C]lesinurad (100 μg per 10 mL)

Drug: Lesinurad 400 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT02039700

RDEA594-131

Details and patient eligibility

About

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 description

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.

Enrollment

10 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.