This study will assess the pharmacokinetics of AFQ056 in subjects with mild, moderate, severe hepatic impairment compared with healthy control subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
118
Novartis Investigative Site
Orlando, Florida, United States
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Balatonfüred, Hungary
Measure: Profile of Pharmacokinetics of AFQ056 in each subjects groups
AUClast, AUCinf, Cmax, Tmax, T1/2, CL/F, Vz/F
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 36, 48, 72, 96, 120 hours post-dose
Measure: : Number of subjects with adverse event in each group
Number and type of adverse events, number and type of findings in standard laboratory results, special laboratory results (Hypothaliamic-pituitary axis, porphyrin profile) electrocardiogram holters, or in vital signs
Time frame: From dose administration (day 1) to 13+/- 2 days after the single dose administration
Measure: Plasma protein binding results of AFQ056 in each groups.
Time frame: 2 hours after single dose administration
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