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Lesinurad Tablet Relative Bioavailability

NCT ID: NCT01986556

Last Updated: 2014-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-05-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

Lesinurad 400 mg (Site 1)

Intervention Type DRUG

Lesinurad 400 mg (Site 2, Lot A)

Intervention Type DRUG

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)

Group Type EXPERIMENTAL

Lesinurad 400 mg (Site 1)

Intervention Type DRUG

Lesinurad 400 mg (Site 2, Lot A)

Intervention Type DRUG

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)

Group Type EXPERIMENTAL

Lesinurad 400 mg (Site 1)

Intervention Type DRUG

Lesinurad 400 mg (Site 2, Lot B)

Intervention Type DRUG

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)

Group Type EXPERIMENTAL

Lesinurad 400 mg (Site 1)

Intervention Type DRUG

Lesinurad 400 mg (Site 2, Lot B)

Intervention Type DRUG

Interventions

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Lesinurad 400 mg (Site 1)

Intervention Type DRUG

Lesinurad 400 mg (Site 2, Lot A)

Intervention Type DRUG

Lesinurad 400 mg (Site 2, Lot B)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ardea Biosciences, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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J. Hall, MD

Role: STUDY_DIRECTOR

Ardea Biosciences, Inc.

Locations

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Glendale, California, United States

Site Status

Countries

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United States

Other Identifiers

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RDEA594-129

Identifier Type: -

Identifier Source: org_study_id

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