Lesinurad Tablet Relative Bioavailability

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT01986556
First received: November 12, 2013
Last updated: September 19, 2014
Last verified: September 2014
  Purpose

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


Condition Intervention Phase
Healthy
Drug: Lesinurad 400 mg (Site 1)
Drug: Lesinurad 400 mg (Site 2, Lot A)
Drug: Lesinurad 400 mg (Site 2, Lot B)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Phase 1, Randomized, Open-Label, Crossover Study in Healthy Adult Male Subjects to Assess the Relative Bioavailability of Lesinurad Tablets Manufactured at Two Different Sites

Further study details as provided by Ardea Biosciences, Inc.:

Primary Outcome Measures:
  • PK profile of lesinurad from plasma [ Time Frame: Day 1 and Day 5 ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Incidence of Adverse Events [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]
    Changes in Laboratory, Electrocardiogram and Vital Signs Parameters


Enrollment: 36
Study Start Date: November 2013
Study Completion Date: May 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lesinurad 400 mg Fasted (Site 1 and Site 2, Lot A)
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)
Experimental: Lesinurad 400 mg Fed (Site 1 and Site 2, Lot A)
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)
Experimental: Lesinurad 400 mg Fasted (Site 1 and Site 2, Lot B)
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)
Experimental: Lesinurad 400 mg Fed (Site 1 and Site 2, Lot B)
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)

Detailed Description:

A change in manufacturing site of lesinurad tablets has been implemented. This study is intended to evaluate the clinical comparability of lesinurad tablets manufactured at the two different sites by assessing relevant clinical Pharmacokinetics (PK) parameters.

  Eligibility

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

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01986556

Locations
United States, California
Glendale, California, United States, 91206
Sponsors and Collaborators
Ardea Biosciences, Inc.
Investigators
Study Director: J. Hall, MD Ardea Biosciences, Inc.
  More Information

No publications provided

Responsible Party: Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT01986556     History of Changes
Other Study ID Numbers: RDEA594-129
Study First Received: November 12, 2013
Last Updated: September 19, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 23, 2014