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Abstract: ASN Annual Meeting -- San Diego |
Albrecht D, Daniel S, Halfon S, et al.
A Double-Blind, Randomized, Placebo-Controlled, Study To Evaluate the Effects of AMG 223 on Tolerability and Phosphorus Excretion in Healthy Volunteers.
ASN Annual Meeting -- San Diego
J Am Soc Nephrol (Nov) 20:367A 2009
AMG 223 (previously ILY101) is a novel, metal free polymer-based phosphate binder in development for the treatment of hyperphosphatemia. This study evaluated the pharmacologic effects and tolerability of AMG 223 in healthy subjects. Twenty-three healthy volunteers were randomized to receive 1 g, 2.5 g, or 5 g doses of AMG 223 or matching placebo TID for 8 days. Subjects were required to consume a phosphate-controlled diet during the study. Urine and feces were collected over a 96-hr interval at the end of baseline and end of study treatment periods to determine change in phosphorus excretion. Tolerability was assessed based on the incidence and severity of adverse events.
No clinically significant drug-related changes were noted in clinical laboratory parameters, vital signs, ECG, or physical examination data. Four drug-related adverse events occurred transiently in 2 subjects who received AMG 223 at 5g TID and were mild to moderate in severity (dyspepsia, eructation, flatulence; dysgeusia). AMG 223 caused a significant dose dependant decrease in urinary phosphorus excretion and a significant increase in fecal phosphorus excretion (see Table).
Mean (+SD) change from baseline in urinary and local phosphorus excretion (mg/day) Endpoint Placebo (N=6) 1g ILY101 (N=6) 2.5g ILY101 (N=5) 5G ILY101 (N=6) Fecal Phosphorus -168 230
-147 218 422 Urine Phosphorus 125 -10 -123 - 302 P-values: *p<0.05; **p<0.001; ***p<0.0001 for comparison vs. placebo group effects
In conclusion, AMG 223 at doses up to 15 g/day was well-tolerated in healthy subjects. AMG 223 effectively and irreversibly bound intestinal phosphorus resulting in a significant dose-dependent increase in fecal phosphorus excretion and a significant decrease in urinary phosphorus excretion.
1Ilypsa is a wholly owned subsidiary of Amgen Inc.
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