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Bioavailability of Lesinurad and Intravenous [14C]Lesinurad

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT02039700
First received: January 16, 2014
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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: Endpoint Classification: Bio-availability Study
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

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: January 2014
Estimated Study Completion Date: March 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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02039700

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

No publications provided

Responsible Party: Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT02039700     History of Changes
Other Study ID Numbers: RDEA594-131
Study First Received: January 16, 2014
Last Updated: March 4, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 17, 2014