The purpose of this study is to characterize the PK and safety profile of LEE011 following a single oral dose in adult subjects with various degrees of renal impairment compared to a matched group of healthy subjects with normal renal function.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
38
400 mg
DaVita Clinical Research
Minneapolis, Minnesota, United States
Novartis Investigative Site
Sofia, Bulgaria
Novartis Investigative Site
Prague, Czech Republic, Czechia
Novartis Investigative Site
Berlin, Germany
Primary Pharmacokinetics (PK) parameters of LEE011 when appropriate
Primary composite PK parameters: Cmax, AUClast, AUCinf, and CL/F. To determine the impact of various degrees of renal impairment on primary PK parameters of LEE011 following a single 400mg oral dose
Time frame: 14 days
Secondary PK parameters of LEE011 when appropriate
Secondary composite PK parameters of LEE011: Tmax, T1/2, Vz/F, and CLr. To determine the impact of various degrees of renal impairment on secondary PK parameters of LEE011 following a single 400 mg oral dose
Time frame: 14 days
PK parameters of LEQ803 (i.e., Cmax, AUClast, AUCinf, Tmax, T1/2)
Composite PK parameters of LEQ803: Cmax, AUClast, AUCinf, Tmax, T1/2. To evaluate the PK profile of LEQ803 in subjects with various degrees of renal impairment following a single 400 mg oral dose
Time frame: 14 days
Frequency of adverse events (AEs)
Safety profile of a single dose of LEE011 in healthy subjects and subjects with varying degrees of hepatic function includes changes observed in physical examination, changes in vital signs, changes in electrocardiograms (ECGs), abnormal laboratory results.
Time frame: From consent to 28 days post-dose
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