Clincosm LogoSign in Get a demo

Lesinurad Tablet Bioequivalence

Sponsor
Ardea Biosciences, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02127775
Collaborator
(none)
54
Enrollment
1
Location
2
Arms
3
Duration (Months)
18.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will assess the bioequivalence of lesinurad tablets manufactured at two different sites.

Condition or Disease Intervention/Treatment Phase
  • Drug: Lesinurad 400 mg (manufactured at Site 1)
  • Drug: Lesinurad 400 mg (manufactured at Site 2)
 Phase 1

Detailed Description

This study is intended to evaluate the clinical comparability of lesinurad tablets manufactured at the 2 different sites by assessing relevant clinical Pharmacokinetics (PK) parameters.

Study Design

Study Type:
Interventional
Actual Enrollment :
54 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
A Phase 1, Randomized, Open-Label, Crossover Study to Assess the Bioequivalence of Lesinurad Tablets From Two Manufacturing Sites in Healthy Adult Male Subjects
Study Start Date :
Apr 1, 2014
Actual Primary Completion Date :
Jun 1, 2014
Actual Study Completion Date :
Jul 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sequence B

Day 1: Lesinurad 400 mg (manufactured at Site 2); Day 5: Lesinurad 400 mg (manufactured at Site 1)

Drug: Lesinurad 400 mg (manufactured at Site 1)

Drug: Lesinurad 400 mg (manufactured at Site 2)
Experimental: Sequence A

Day 1: Lesinurad 400 mg (manufactured at Site 1); Day 5: Lesinurad 400 mg (manufactured at Site 2)

Drug: Lesinurad 400 mg (manufactured at Site 1)

Drug: Lesinurad 400 mg (manufactured at Site 2)

Outcome Measures

Primary Outcome Measures

  1. PK profile of lesinurad from plasma [Day 1 and Day 5]

    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.

Secondary Outcome Measures

  1. Incidence of Adverse Events [5 weeks]

    Changes in Laboratory, Electrocardiogram and Vital Signs Parameters

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Austin Texas United States 78744

Sponsors and Collaborators

  • Ardea Biosciences, Inc.

Investigators

  • Study Director: J. Hall, Ardea Biosciences, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT02127775
Other Study ID Numbers:
  • RDEA594-132
First Posted:
May 1, 2014
Last Update Posted:
Sep 22, 2014
Last Verified:
Sep 1, 2014
Additional relevant MeSH terms:
Lesinurad

Study Results

No Results Posted as of Sep 22, 2014