PK/PD and safety of a single dose of TMX-67 (febuxostat) in subjects with mild and moderate renal impairment.
A single oral dose of 20 mg febuxostat was administered to subjects with normal, mild or moderate impairment in renal function. There was less than a 2-fold difference in AUC of plasma unchanged febuxostat among the renal function groups, and changes in plasma urate levels from pre-dose levels were not significant. A total of five adverse events were reported with all mild in severity. The results indicate that renal impairment will have little clinical impact on the pharmacokinetics (PK), pharmacodynamics (PD) and safety of the study drug.
Hoshide
S
S
Teijin Ltd., Tokyo, Japan.
Takahashi
Y
Y
Ishikawa
T
T
Kubo
J
J
Tsuchimoto
M
M
Komoriya
K
K
Ohno
I
I
Hosoya
T
T
D019540:Area Under Curve; D004791:Enzyme Inhibitors / Q000009:adverse effects / Q000493:pharmacokinetics; D000069465:Febuxostat; D005260:Female; D006801:Humans; D007668:Kidney / Q000187:drug effects; D007674:Kidney Diseases / Q000188:drug therapy*; D008297:Male; D051437:Renal Insufficiency / Q000188:drug therapy; D013844:Thiazoles / Q000009:adverse effects / Q000493:pharmacokinetics* / Q000627:therapeutic use; D013997:Time Factors; D014969:Xanthine Oxidase / Q000037:antagonists & inhibitors*
D004791:Enzyme Inhibitors; D013844:Thiazoles; D000069465:Febuxostat; D014969:Xanthine Oxidase