CompletedNCT01613690Updated Dec 19, 2020

Comparing the Pharmacokinetics, Safety and Tolerability of NVA237 in Renal Impairment

A Phase 1 interventional study of NVA237 in Renal Impairment, sponsored by Novartis Pharmaceuticals. Completed at 1 site in Russian Federation. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-19.

Sponsored by Novartis Pharmaceuticals · Phase 1, Interventional, and Other

Phase: Phase 1
Study type: Interventional
Enrollment: 48
Allocation: Non-randomized
Ages: 18 Years to 70 Years
Sex: All

Study summary

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.

Conditions studied

Renal Impairment

Browse trials for

Renal Insufficiency 1,995

Keywords

Renal impairment
NVA237
Pharmacokinetics

In context

Renal Insufficiency

1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.

This study's enrollment of 48 is above the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.

Browse Renal Insufficiency studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Male and female subjects age 18 to 70 years of age inclusive.
Female subjects of childbearing potential must be using two acceptable methods of contraception, (e.g., intra-uterine device plus condom, spermicidal gel plus condom, diaphragm plus condom, etc.), from the time of screening and for the duration of the study, through study completion.
Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 17 to 35 kg/m2.
Able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent
For renal insufficient subjects only - Subjects must have stable renal disease without evidence of renal progressive disease (for the purpose of this study stable renal disease will be defined as no significant change for 12 weeks).
For health subjects only - A serum creatinine within the normal range and an eGFR >80 mL/min/1.73 m2.
For health subjects only - Matched to at least one renal impaired subjects undergoing study by age (±5 years), sex and weight (±10% BMI).

Exclusion criteria

Exclusion Criteria:

Smokers (use of tobacco products in the previous 3 months). Smokers will be defined as any subject who reports tobacco use and/or who has a urine cotinine ≥ 500 ng/mL. If non-smoking subject are too difficult to recruit, smokers may be allowed to participate in the study provided they commit to smoke no more than 10 cigarettes/day during the days of PK-assessment
For healthy subjects, use of any prescription drugs, herbal and fitness/bodybuilding/athletic performance-enhancing supplements, within four (4) weeks prior to initial dosing, and/or over-the-counter (OTC) medication, dietary supplements (vitamins included) within two (2) weeks prior to initial dosing
Recent (within the last three [3] years) and/or recurrent history of autonomic dysfunction (e.g., recurrent episodes of fainting (unless related to water withdrawal during dialysis), palpitations, etc).
Recent (within the last three [3] years) and/or recurrent history of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated).
History of multiple and recurring allergies or allergy to the investigational compound/compound class being used in this study.
Total WBC count which falls outside the range of 3000-12,000/μL, or platelets \<100,000/μl at screening.
History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.

Other protocol-defined inclusion/exclusion criteria may apply.

Study design

Phase: Phase 1
Primary purpose: Other
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 48 participants (actual)

Study arms

Experimental
Healthy volunteers
control group receiving 100 μg NVA237
Drug: NVA237
Experimental
Mild renal impairment
(eGFR 50-80 mL/min/1.73m2) receiving 100 μg NVA237
Drug: NVA237
Experimental
Moderate renal impairment
(eGFR 30-49 mL/min/1.73m2) receiving 100 μg NVA237
Drug: NVA237
Experimental
Severe renal impairment
(eGFR \<30 mL/min1.73m2) receiving 100 μg NVA237
Drug: NVA237
Experimental
End-stage subjects requiring dialysis (ESRD)
receiving 100 μg NVA237
Drug: NVA237

Interventions

DrugNVA237
NVA237 is administered via a BREEZHALER device

What researchers measure

Primary outcomes

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
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

Secondary outcomes

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

Study locations

1 site

Novartis Investigative Site
Moscow, Russian Federation

References and documents

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 19, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01613690
Lead sponsor: Novartis Pharmaceuticals
Responsible party: Sponsor
First posted: Jun 7, 2012
Start date: Jun 2010
Primary completion: Nov 2010
Completion: Nov 2010
Last update: Dec 19, 2020

Study contacts

Novartis Pharmaceuticals

study director · Novartis Pharmaceuticals

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

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