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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy volunteers | Experimental | control group receiving 100 μg NVA237 |
|
| Mild renal impairment | Experimental | (eGFR 50-80 mL/min/1.73m2) receiving 100 μg NVA237 |
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| Moderate renal impairment | Experimental | (eGFR 30-49 mL/min/1.73m2) receiving 100 μg NVA237 |
|
| Severe renal impairment | Experimental | (eGFR <30 mL/min1.73m2) receiving 100 μg NVA237 |
|
| End-stage subjects requiring dialysis (ESRD) | Experimental | receiving 100 μg NVA237 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NVA237 | Drug | NVA237 is administered via a BREEZHALER device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 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 | 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 | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 1 of each treatment period |
| Change in effect of dialysis in End-stage subjects requiring dialysis using PK parameter AUClast |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Moscow | Russia |
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| Label | URL |
|---|---|
| Results for CNVA237A2105 can be found on the Novartis Clinical Trial Results Website | View source |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D006024 | Glycopyrrolate |
| ID | Term |
|---|---|
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |
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Blood samples will be collected at various time points on each visit day; Compound: NVA237 100ug, Matrix: Plasma, Analyte: NVA237
| 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 | 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 | 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 | 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 | Day 1, 2, 3, 4 and 5 |
Blood samples will be collected at various time points on each visit day; Compound: NVA237 100ug, Matrix: Plasma, Analyte: NVA237 |
| 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 | Reviewed during each study visit |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D011759 |
| Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |