This study will compare the pharmacokinetics of LCQ908 in subjects with varying degrees of renal impairment to healthy subjects
Study Type
INTERVENTIONAL
Purpose
OTHER
Masking
NONE
Enrollment
58
Participants will receive a single oral dose of LCQ908
Novartis Investigative Site
Orlando, Florida, United States
Novartis Investigative Site
Knoxville, Tennessee, United States
Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (AUClast) of LCQ908
Time frame: Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing
Area under the plasma concentration-time profile from time zero extrapolated to infinite time [AUC(0-inf)] of LCQ908
Time frame: Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing
Maximum plasma concentration (Cmax) of LCQ908
Time frame: Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing
Number of participants with adverse events (AEs), serious adverse events (SAEs) and death
AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. SAEs are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital abnormalities or birth defects, or are other conditions which in the judgment of investigators represent significant hazards.
Time frame: Day 29
The apparent systemic clearance (CL/F) of LCQ908 following extra vascular administration
Time frame: Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing
Time to maximum plasma concentration of LCQ908
Time frame: Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing
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The time required for the concentration of the drug to reach half of its original value
Time frame: Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing
Apparent volume of distribution of LCQ908 during the terminal elimination phase following extra vascular administration
Time frame: Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing
LCQ908 protein binding: unbound area under curve (AUCc) of LCQ908
Time frame: 10 and 24 hours
LCQ908 protein binding: unbound observed maximum plasma (Cmax) of LCQ908
Time frame: 10 and 24 hours
LCQ908 protein binding: unbound apparent systemic clearance from plasma (CL/Fu) following extra vascular administration
Time frame: 10 and 24 hours