Bioavailability of Lesinurad and Intravenous [14C]Lesinurad

NCT02039700 | Completed Phase 1

• 1 other identifier: RDEA594-131
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Characteristics of bioavailability in terms of lesinurad Pharmacokinetics (PK) profile from plasma.

  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).

  Day 1 to Day 5

• PK profile of [14C]lesinurad from plasma

  PK profile in terms of Cmax, AUC, t½, MRT, total body clearance (CL), and volume of distribution at steady state (Vss).

  Day 1 to Day 5

Secondary Outcomes (1)

• Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters

  5 weeks

Study Arms (1)

Lesinurad and [14C]lesinurad

EXPERIMENTAL

Single oral dose of lesinurad and single infusion of \[14C\]lesinurad

Drug: Lesinurad 400 mg; Drug: [14C]lesinurad (100 μg per 10 mL)

Interventions

Lesinurad 400 mg DRUG

Lesinurad and [14C]lesinurad

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

Lesinurad and [14C]lesinurad

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ardea Biosciences, Inc.: lead

Study Sites (1)

Unknown Facility

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Interventions

lesinurad

Study Officials

• J. Hall

  Ardea Biosciences, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2014
• First Posted: January 20, 2014
• Study Start: January 1, 2014
• Primary Completion: February 1, 2014
• Study Completion: April 1, 2014
• Last Updated: May 20, 2014

Record last verified: 2014-05

Locations

US (1)