Lesinurad Tablet Relative Bioavailability

Ardea Biosciences

Status and phase: Completed; Phase 1

Conditions: Healthy

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01986556

RDEA594-129

Details and patient eligibility

About

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

Full 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.

Enrollment: 36 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 4 patient groups

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

Experimental group

Description:

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

Treatment:

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

Drug: Lesinurad 400 mg (Site 1)

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

Experimental group

Description:

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

Treatment:

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

Drug: Lesinurad 400 mg (Site 1)

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

Experimental group

Description:

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

Treatment:

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

Drug: Lesinurad 400 mg (Site 1)

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

Experimental group

Description:

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

Treatment:

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

Drug: Lesinurad 400 mg (Site 1)