Lesinurad Tablet Bioequivalence
A Phase 1, Randomized, Open-Label, Crossover Study to Assess the Bioequivalence of Lesinurad Tablets From Two Manufacturing Sites in Healthy Adult Male Subjects
1 other identifier
interventional
54
1 country
1
Brief Summary
This study will assess the bioequivalence of lesinurad tablets manufactured at two different sites.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Apr 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 28, 2014
CompletedFirst Posted
Study publicly available on registry
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedSeptember 22, 2014
September 1, 2014
2 months
April 28, 2014
September 19, 2014
Conditions
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 from zero to 24 hours post dose (AUC last) and from zero to infinity (AUC ∞); and apparent terminal half-life (t1/2). Point estimates and 90% confidence intervals for the ratio of geometric means for Cmax, AUC last and AUC∞ between test and reference formulations.
Day 1 and Day 5
Secondary Outcomes (1)
Incidence of Adverse Events
5 weeks
Study Arms (2)
Sequence B
EXPERIMENTALDay 1: Lesinurad 400 mg (manufactured at Site 2); Day 5: Lesinurad 400 mg (manufactured at Site 1)
Sequence A
EXPERIMENTALDay 1: Lesinurad 400 mg (manufactured at Site 1); Day 5: Lesinurad 400 mg (manufactured at Site 2)
Interventions
Eligibility Criteria
You may qualify if:
- Subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 40 kg/m2.
- Subject has a Screening serum urate level ≤ 7 mg/dL. ˗ Subject is free of any clinically significant disease or medical condition, per the Investigator's judgment.
You may not qualify if:
- Subject has any gastrointestinal disorder that affects motility and/or absorption.
- Subject has a history or suspicion of kidney stones.
- Subject has undergone major surgery within 3 months prior to Screening.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Austin, Texas, 78744, United States
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
J. Hall
Ardea Biosciences, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2014
First Posted
May 1, 2014
Study Start
April 1, 2014
Primary Completion
June 1, 2014
Study Completion
July 1, 2014
Last Updated
September 22, 2014
Record last verified: 2014-09