Effects of renal function on pharmacokinetics and pharmacodynamics of lesinurad in adult volunteers

Autor: Gillen M, Valdez S, Zhou D, Kerr B, Lee CA, Shen Z
Jazyk: angličtina
Rok vydání: 2016
Předmět:
Zdroj: Drug Design, Development and Therapy, Vol Volume 10, Pp 3555-3562 (2016)
Druh dokumentu: article
ISSN: 1177-8881
Popis: Michael Gillen,1 Shakti Valdez,2 Dongmei Zhou,2 Bradley Kerr,2 Caroline A Lee,2 Zancong Shen2 1AstraZeneca LP, Gaithersburg, MD, 2Ardea Biosciences, Inc., San Diego, CA, USA Introduction: Lesinurad is a selective uric acid reabsorption inhibitor approved for the treatment of gout in combination with a xanthine oxidase inhibitor (XOI) in patients who have not achieved target serum uric acid (sUA) levels with an XOI alone. Most people with gout have chronic kidney disease. The pharmacokinetics, pharmacodynamics, and safety of lesinurad were assessed in subjects with impaired renal function. Methods: Two Phase I, multicenter, open-label, single-dose studies enrolled subjects with normal renal function (estimated creatinine clearance [eCrCl] >90 mL/min; N=12) or mild (eCrCl 60–89 mL/min; N=8), moderate (eCrCl 30–59 mL/min; N=16), or severe (eCrCl
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