Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01613690
Other study ID # CNVA237A2105
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date June 2010
Est. completion date November 2010

Study information

Verified date June 2012
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date November 2010
Est. primary completion date November 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
NVA237
NVA237 is administered via a BREEZHALER device

Locations

Country Name City State
Russian Federation Novartis Investigative Site Moscow

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 Day 1, 2, 3, 4 and 5
Primary 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
Primary 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
Primary 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
Primary 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
Secondary 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
Secondary 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 Day 1 of each treatment period
Secondary 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
See also
  Status Clinical Trial Phase
Completed NCT01937975 - The Pharmacokinetics of Grazoprevir (MK-5172) and Elbasvir (MK-8742) in Participants With Renal Insufficiency (MK-5172-050) Phase 1
Completed NCT03284164 - Evaluation of Effect of Renal Impairment on the PK of Tenofovir Exalidex Phase 1
Completed NCT05992155 - A Study of TAK-279 in Adults With or Without Kidney Problems Phase 1
Completed NCT05004311 - The Effect of Severe Kidney Impairment on Cenerimod Pharmacokinetics Phase 1
Completed NCT04963738 - A Study of JNJ-73763989 in Adult Participants With Renal Impairment Phase 1
Terminated NCT02508740 - Single Oral Dose of Bevenopran in Patients With Varying Degrees of Renal Impairment Phase 1
Active, not recruiting NCT01529658 - Renal Hypothermia During Partial Nephrectomy N/A
Terminated NCT00984113 - Pharmacokinetics of Elinogrel in Healthy Volunteers and Patients With Mild, Moderate, and Severe Renal Impairment Phase 1
Completed NCT00842868 - The CASABLANCA Study: Catheter Sampled Blood Archive in Cardiovascular Diseases N/A
Completed NCT00750620 - A Pharmacokinetic Study of YM178 in Normal Subjects and Those With Mild, Moderate, and Severe Renal Impairment Phase 1
Completed NCT00499187 - Fanconi Syndrome Due to ARVs in HIV-Infected Persons Phase 4
Completed NCT01331941 - A Pharmacokinetic Study of AMG 386 in Cancer Subjects With Normal and Impaired Renal Function Phase 1
Completed NCT05489614 - A Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Olpasiran in Participants With Normal Renal Function and Participants With Various Degrees of Renal Impairment Phase 1
Completed NCT03259087 - Pharmacokinetics (PK) and Safety of a Single Intravenous (IV) Dose of MK-3866 in Participants With Impaired Renal Function and in Healthy Controls (MK-3866-005) Phase 1
Completed NCT05086107 - Pharmacokinetics and Safety of BV100 Administered as Single Intravenous Infusion to Subjects With Renal Impairment Phase 1
Recruiting NCT05349851 - Bowel Cleansing With Renal Impairment
Completed NCT03660241 - A Renal Impairment Study for PF-04965842 Phase 1
Recruiting NCT06037031 - A Study to Learn How the Body Processes the Study Medicine Called PF-07923568 in People With Loss of Kidney Function Phase 1
Completed NCT03289208 - Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Renal Impairment Phase 1
Completed NCT02942810 - To Investigate The Pharmacokinetics Of Intravenous WCK 5222 (FEP-ZID) In Patients With Renal Impairment Phase 1