[HTML][HTML] Acetylator status impacts amifampridine phosphate (Firdapse™) pharmacokinetics and exposure to a greater extent than renal function
PE Haroldsen, Z Sisic, J Datt, DG Musson… - Clinical Therapeutics, 2017 - Elsevier
Purpose The purpose of this study is to evaluate safety, tolerability, and pharmacokinetic
(PK) properties of amifampridine phosphate (Firdapse™) and its major inactive 3-N-acetyl
metabolite in renally impaired and healthy individuals with slow acetylator (SA) and rapid
acetylator (RA) phenotypes. Methods This was a Phase I, multicenter, open-label study of
the PK properties and safety profile of amifampridine phosphate in individuals with normal,
mild, moderate, or severely impaired renal function. Amifampridine phosphate was given as …
(PK) properties of amifampridine phosphate (Firdapse™) and its major inactive 3-N-acetyl
metabolite in renally impaired and healthy individuals with slow acetylator (SA) and rapid
acetylator (RA) phenotypes. Methods This was a Phase I, multicenter, open-label study of
the PK properties and safety profile of amifampridine phosphate in individuals with normal,
mild, moderate, or severely impaired renal function. Amifampridine phosphate was given as …