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Trial record 1 of 19 for:    lesinurad
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Bioavailability of Lesinurad and Intravenous [14C]Lesinurad

This study has been completed.
Information provided by (Responsible Party):
Ardea Biosciences, Inc. Identifier:
First received: January 16, 2014
Last updated: May 16, 2014
Last verified: May 2014
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.

Condition Intervention Phase
Healthy Drug: Lesinurad 400 mg Drug: [14C]lesinurad (100 μg per 10 mL) Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Ardea Biosciences, Inc.:

Primary 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).

Secondary Outcome Measures:
  • Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters [ Time Frame: 5 weeks ]

Enrollment: 10
Study Start Date: January 2014
Study Completion Date: April 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lesinurad and [14C]lesinurad
Single oral dose of lesinurad and single infusion of [14C]lesinurad
Drug: Lesinurad 400 mg Drug: [14C]lesinurad (100 μg per 10 mL)

Detailed 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.

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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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Please refer to this study by its identifier: NCT02039700

United States, Wisconsin
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Ardea Biosciences, Inc.
Study Director: J. Hall Ardea Biosciences, Inc.
  More Information

Responsible Party: Ardea Biosciences, Inc. Identifier: NCT02039700     History of Changes
Other Study ID Numbers: RDEA594-131
Study First Received: January 16, 2014
Last Updated: May 16, 2014

Additional relevant MeSH terms:
Uricosuric Agents
Gout Suppressants
Antirheumatic Agents
Renal Agents processed this record on June 23, 2017