Study Complete
Sponsor ID
20080676
Pharmacokinetics Study of AMG 423 in Healthy Subjects and Subjects with Various Degrees of Renal Insufficiency
Study Details
A phase 1, open-label study in subjects with normal renal function and subjects with various degrees of renal insufficiency, including patients with end-stage renal disease (ESRD) requiring hemodialysis. The primary objective is to evaluate the single-dose PK of AMG 423 in subjects with various degrees of renal insufficiency, including patients with end-stage renal disease requiring hemodialysis.
Protocol Summary
Primary Outcome Measures
AMG 423 Pharmacokinetic Parameters
Timeframe: Twenty time points, up to eight days
Secondary Outcome Measures
Other Total AMG 423 PK Parameters
Timeframe: Twenty time points, up to eight days
AMG 423 Dialysis Clearance
Timeframe: Hours 4, 5, 6, 7 & 8 post-dose
AMG 423 Metabolites
Timeframe: Twenty time points, up to eight days
Safety
Timeframe: Up to 46 days, including a 28 day screening period
Locations
Location
Research Site
Orlando, FL, United States, 32809
Status
Recruiting