The aim of this study was to characterize the pharmacokinetics and safety of AFQ056 in subjects with a different degree of renal impairment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
48
Novartis Investigative Site
Kiel, Germany
Measure: Area under the plasma concentration-time curve from time zero to infinity (AUCinf)
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 48, 72 hours post dose
Measure: Area under the curve from time zero to the last measurable concentration sampling time (Tlast) [mass x time x volume-1] (AUClast)
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 48, 72 hours post dose
Measure: Maximum observed plasma concentration (Cmax)
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 48, 72 hours post dose
Measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 48, 72 hours post dose
Measure: Terminal elimination half-life (T1/2)
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 48, 72 hours post dose
Measure: The apparent systemic (or total body) clearance from plasma following extravascular administration [volume / time] (CL/F)
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 48, 72 hours post dose
Measure: The apparent volume of distribution during the terminal elimination phase following oral administration [volume] (Vz/F)
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 48, 72 hours post dose
Measure: Amount of drug excreted into the urine from time zero to time't' where t is a defined time point after administration [mass units or % of dose] (Ae0-t)
Time frame: 4 days
Measure: The renal clearance from plasma [volume / time] (CLr)
Time frame: 4 days
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Physical examination
Time frame: Screening, Day -1, Day 8 +/- 2 days
Measure: Vital signs and body measurements
Time frame: Screening, Day -1, Day 1, Day 8 +/- 2 days
Measure: ECG
Time frame: Screening, Day -1, Day 1, Day 8 +/- 2 days
Measure: pulse oximetry
Time frame: Screening, Day -1, Day 1, Day 8 +/- 2 days
Measure: hematology
Time frame: Screening, Day -1, Day 4, Day 8 +/- 2 days
Measure: blood chemistry
Time frame: Screening, Day -1, Day 2, Day 4, Day 8 +/- 2 days
Measure: urinalysis
Time frame: Screening, Day -1, Day 4, Day 8 +/- 2 days
Measure: AE (adverse events) monitoring
Time frame: During the study (up to 10 days)
SAE (serious adverse events) monitoring
Time frame: During the study (up to 10 days) and up to 30 days after study completion