Lesinurad/Allopurinol 200/300 FDC Tablets Bioavailability

Completed · Phase 1

Conditions studied: Healthy

In brief

This study will assess relative bioavailability of lesinurad/allopurinol fixed dose combination (FDC), its individual components and the effect of food.

Key facts

Study ID

NCT02581553

Run by

Ardea Biosciences, Inc.

People needed

116

Starts

2015-10-01

Expected to finish

2016-08-01

Last updated by the study team

2016-12-19

Who can join

Age: 18 and older, up to 65. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Body mass index ranging between 18 kg/m2 and 40 kg/m2.
• Screening serum urate level is ≤ 7.0 mg/dL.

You may not qualify if…

• Asian subject who has a positive test for the HLA-B*5801 allele.
• History or suspicion of kidney stones.
• Estimated creatinine clearance, as determined at Screening, of < 90 mL/min calculated by the Cockcroft-Gault formula using ideal body weight.
• Undergone major surgery within 3 months prior to Screening.
• Donated blood or experienced significant blood loss (> 450 mL) within 12 weeks prior to Day 1or has given a plasma donation within 4 weeks prior to Day 1.
• Inadequate venous access or unsuitable veins for repeated venipuncture.
• Received any strong or moderate enzyme-inducing drug or product within 2 months prior to Screening.

Where it is running

• Study site — Austin, Texas, United States

Full record on ClinicalTrials.gov

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