This study will assess the pharmacokinetics, safety and tolerability of a single dose of AGO178C in subjects with mild, moderate, severe renal impairment and end-stage renal disease with that in healthy matched control subjects.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
32
Novartis Investigative Site
Miami, Florida, United States
Novartis Investigative Site
Orlando, Florida, United States
Novartis Investigative Site
Minneapolis, Minnesota, United States
Novartis Investigative Site
Knoxville, Tennessee, United States
Measure: Composite of AGO178C pharmacokinetics in blood and urine samples.
Time frame: pre dose, 2 min, 5 min, 10 min, 20 min, 30 min, 45 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 12 h, 24 h and 36 h post dose
Measure: Safety and tolerability of AGO178C as assessed by adverse events reports, vital signs, ECGs and safety laboratory tests.
Time frame: Up to 9 Days post dose
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