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

Novartis

Status and phase: Completed; Phase 1

Conditions: Renal Impairment

Treatments: Drug: NVA237

Study type: Interventional

Funder types: Industry

Identifiers

NCT01613690

CNVA237A2105

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

• 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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 5 patient groups

Healthy volunteers

Experimental group

Description:

control group receiving 100 μg NVA237

Treatment:

Drug: NVA237

Mild renal impairment

Experimental group

Description:

(eGFR 50-80 mL/min/1.73m2) receiving 100 μg NVA237

Treatment:

Drug: NVA237

Moderate renal impairment

Experimental group

Description:

(eGFR 30-49 mL/min/1.73m2) receiving 100 μg NVA237

Treatment:

Drug: NVA237

Severe renal impairment

Experimental group

Description:

(eGFR \<30 mL/min1.73m2) receiving 100 μg NVA237

Treatment:

Drug: NVA237

End-stage subjects requiring dialysis (ESRD)

Experimental group

Description:

receiving 100 μg NVA237

Treatment:

Drug: NVA237