The purpose of this study is to see how the body processes and gets rid of NVA237 in people who have impaired kidney function compared to people whose kidney function is normal.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
48
NVA237 is administered via a BREEZHALER device
Novartis Investigative Site
Moscow, Russia
Concentration of NVA2105 using PK parameter of primary interest - area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUClast)
Blood samples will be collected at various time points on each visit day; Compound: NVA237 100ug, Matrix: Plasma, Analyte: NVA237
Time frame: Day 1, 2, 3, 4 and 5
Concentration of NVA2105 using PK parameter of primary interest - maximum plasma concentration (Cmax)
Blood samples will be collected at various time points on each visit day; Compound: NVA237 100ug, Matrix: Plasma, Analyte: NVA237
Time frame: Day 1, 2, 3, 4 and 5
Concentration of NVA2105 using PK parameter of primary interest - renal clearance (CLR)
Blood samples will be collected at various time points on each visit day; Compound: NVA237 100ug, Matrix: Plasma, Analyte: NVA237
Time frame: Day 1, 2, 3, 4 and 5
Concentration of NVA2105 using PK parameter of secondary interest - time to Cmax (Tmax)
Blood samples will be collected at various time points on each visit day; Compound: NVA237 100ug, Matrix: Plasma, Analyte: NVA237
Time frame: Day 1, 2, 3, 4 and 5
Concentration of NVA2105 using PK parameter of secondary interest - AUC extrapolated to infinity (AUCinf)
Blood samples will be collected at various time points on each visit day; Compound: NVA237 100ug, Matrix: Plasma, Analyte: NVA237
Time frame: Day 1, 2, 3, 4 and 5
Concentration of NVA2105 using PK parameter of secondary interest - terminal elimination half-life, determined from plasma concentrations and urinary excretion rates (T1/2)
Blood samples will be collected at various time points on each visit day; Compound: NVA237 100ug, Matrix: Plasma, Analyte: NVA237
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Time frame: Day 1, 2, 3, 4 and 5
Concentration of NVA2105 using PK parameter of secondary interest - apparent systemic clearance (CL/F)
Blood samples will be collected at various time points on each visit day; Compound: NVA237 100ug, Matrix: Plasma, Analyte: NVA237
Time frame: Day 1, 2, 3, 4 and 5
Concentration of NVA2105 using PK parameter - amount excreted into the urine from time 0 to 96 h post-dose (Ae0-96h)
Samples will be collected at various time points on each visit day; Compound: NVA237 100ug, Matrix: Urine, Analyte: NVA237
Time frame: Day 1, 2, 3, 4 and 5
Concentration of NVA2105 using PK parameter - T1/2
Samples will be collected at various time points on each visit day; Compound: NVA237 100ug, Matrix: Urine, Analyte: NVA237
Time frame: Day 1, 2, 3, 4 and 5
Concentration of NVA2105 using PK parameter - CLR
Samples will be collected at various time points on each visit day; Compound: NVA237 100ug, Matrix: Urine, Analyte: NVA237
Time frame: Day 1, 2, 3, 4 and 5
Change in effect of dialysis in End-stage subjects requiring dialysis (ESRD) using PK parameter Cmax
Blood samples will be collected at various time points on each visit day; Compound: NVA237 100ug, Matrix: Plasma, Analyte: NVA237
Time frame: Day 1 of each treatment period
Change in effect of dialysis in End-stage subjects requiring dialysis using PK parameter AUClast
Blood samples will be collected at various time points on each visit day; Compound: NVA237 100ug, Matrix: Plasma, Analyte: NVA237
Time frame: Day 1 of each treatment period
Safety and tolerability of a single inhalation dose of 100μg NVA237 in subjects with mild, moderate, severe, and end-stage renal impairment
Adverse events will be based on evaluation of physical signs, electrocardiograms and clinical laboratory assessments
Time frame: Reviewed during each study visit