Lesinurad Tablet Relative Bioavailability

NCT01986556 | Completed Phase 1

• 1 other identifier: RDEA594-129
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess the relative bioavailability of lesinurad tablets, manufactured at two different sites.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• PK profile of lesinurad from plasma

  PK endpoints in terms of maximum observed concentration (Cmax); time of occurrence of maximum observed concentration (Tmax); area under the plasma concentration time curve (AUC); and apparent terminal half-life (t1/2).

  Day 1 and Day 5

Secondary Outcomes (1)

• Incidence of Adverse Events

  5 weeks

Study Arms (4)

Lesinurad 400 mg Fasted (Site 1 and Site 2, Lot A)

EXPERIMENTAL

Day 1: Lesinurad 400 mg (Site 1 or Site 2, Lot A) Day 5: Lesinurad 400 mg (Site 1 or Site 2, Lot A)

Drug: Lesinurad 400 mg (Site 1); Drug: Lesinurad 400 mg (Site 2, Lot A)

Lesinurad 400 mg Fed (Site 1 and Site 2, Lot A)

EXPERIMENTAL

Day 1: Lesinurad 400 mg (Site 1 or Site 2, Lot A) Day 5: Lesinurad 400 mg (Site 1 or Site 2, Lot A)

Drug: Lesinurad 400 mg (Site 1); Drug: Lesinurad 400 mg (Site 2, Lot A)

Lesinurad 400 mg Fasted (Site 1 and Site 2, Lot B)

EXPERIMENTAL

Day 1: Lesinurad 400 mg (Site 1 or Site 2, Lot B) Day 5: Lesinurad 400 mg (Site 1 or Site 2, Lot B)

Drug: Lesinurad 400 mg (Site 1); Drug: Lesinurad 400 mg (Site 2, Lot B)

Lesinurad 400 mg Fed (Site 1 and Site 2, Lot B)

EXPERIMENTAL

Day 1: Lesinurad 400 mg (Site 1 or Site 2, Lot B) Day 5: Lesinurad 400 mg (Site 1 or Site 2, Lot B)

Drug: Lesinurad 400 mg (Site 1); Drug: Lesinurad 400 mg (Site 2, Lot B)

Interventions

Lesinurad 400 mg (Site 1) DRUG

Lesinurad 400 mg Fasted (Site 1 and Site 2, Lot A); Lesinurad 400 mg Fasted (Site 1 and Site 2, Lot B); Lesinurad 400 mg Fed (Site 1 and Site 2, Lot A); Lesinurad 400 mg Fed (Site 1 and Site 2, Lot B)

Lesinurad 400 mg (Site 2, Lot A) DRUG

Lesinurad 400 mg Fasted (Site 1 and Site 2, Lot A); Lesinurad 400 mg Fed (Site 1 and Site 2, Lot A)

Lesinurad 400 mg (Site 2, Lot B) DRUG

Lesinurad 400 mg Fasted (Site 1 and Site 2, Lot B); Lesinurad 400 mg Fed (Site 1 and Site 2, Lot B)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has a body weight ≥ 50 kg (110 lbs) and a body mass index (BMI) ≥ 18 and ≤ 40 kg/m2.
• Subject has a Screening sUA value ≤ 7.0 mg/dL.
• Subject is free of any clinically significant disease that requires a physician's care and/or would interfere with study evaluations or procedures.
• Subject has no clinically relevant abnormalities in vital signs, ECG, physical examination or safety laboratory values per the Investigator's judgment.

You may not qualify if:

• Subject has a history or clinical manifestations of significant metabolic, hematological, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urological, or psychiatric disorders.
• Subject has a history or suspicion of kidney stones.
• Subject has a history of asthma.
• Subject has undergone major surgery within 3 months prior to Day 1.
• Subject has donated blood or experienced significant blood loss (\> 450 mL) within 12 weeks prior to Day 1 or gave a plasma donation within 4 weeks prior to the Screening visit.
• Subject has inadequate venous access or unsuitable veins for repeated venipuncture.

Sponsors & Collaborators

• Ardea Biosciences, Inc.: lead

Study Sites (1)

Unknown Facility

Glendale, California, 91206, United States

Location

MeSH Terms

Interventions

lesinurad

Study Officials

• J. Hall, MD

  Ardea Biosciences, Inc.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: November 12, 2013
• First Posted: November 18, 2013
• Study Start: November 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: May 1, 2014
• Last Updated: September 22, 2014

Record last verified: 2014-09

Locations

US (1)