Absolute bioavailability of inhaled NVA237

• Research type

  Research Study

• Full title

  A randomized, partly double-blind, two-part, study to determine the absolute bioavailability of inhaled NVA237 and to compare the pharmacodynamics, pharmacokinetics, safety and tolerability of a single dose of inhaled NVA237 with other routes of administration in healthy subjects

• IRAS ID

  60509

• Contact name

  Leonard Siew

• Sponsor organisation

  Novartis

• Eudract number

  2010-020960-39

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The drug being tested in this study is NVA237. It is being developed for the treatment of chronic obstructive pulmonary disease (COPD). COPD refers to chronic bronchitis and emphysema, a pair of two commonly co-existing diseases of the lungs in which the airways become inflamed and the small airsacs of the lungs become damaged. This leads to a limitation of the flow of air to and from the lungs causing shortness of breath. In contrast to asthma, the limitation of airflow is poorly reversible and usually gets progressively worsen over time. There is an urgent medical need for therapies that could slow disease progression by targeting the underlying Mechanisms associated with the changes in the lungs in patients with COPD. NVA237 is a new form of an existing type of medicine, known as long acting bronchodilators, which, by opening up the airways (breathing tubes) helps to make it easier to breathe and control COPD symptoms. Existing long acting bronchodilators open up the airways by either activating the -flight or fight-(sympathetic) response or by inhibiting the -rest and digest- (partsympathetic) response in the airways. Both types of existing long acting bronchodilators are currently used in the treatment of COPD. Some patients with COPD are on both of these types of long acting bronchodilators to make it easier for them to breathe and to control their symptoms. NVA237 like existing long acting bronchodilators act by blocking the partsympathetic response. It has a longer duration of action than most of the current long acting bronchodilators. This longer duration of action allows NVA237 to be an effective treatment when given once a day.NVA237 is being developed by Novartis as an inhaled treatment to control the symptoms and exacerbations of COPD, and reduce the progression and severity of the disease. The intravenous (through the vein) form of the active compound in NVA237 is a licensed medication in the United Kingdom. The purpose of this research study is to evaluate how the body handles (absorbs, distributes, breaks down and eliminates) single doses of NVA237 when delivered by inhalation, intravenously (through the vein) and orally (through the mouth).We will also be evaluating the safety and tolerability of NVA237 (in particular its effect on the heart rate) and how much NVA237 enters the blood circulation by collecting blood and urine samples from healthy volunteers during the study. We are also investigating what it is broken down into, when given by inhalation and how much of the drug is cleared from the body via the kidneys. This will all be done by analysis of blood and urine samples taken from healthy volunteers at various point during the study. The study will take place at Quintiles Drug research Unit at Guy's Hospital, Quintiles Ltd. The study involves several visits to the research unit, with a pre-study screening visit and a post-study follow-up visit. 24 healthy volunteers are expected to complete the study. The information gained in this study will help the sponsor of this study to determine whether NVA237 is a suitable treatment for patients with COPD.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  10/IEC05/26

• Date of REC Opinion

  6 Oct 2010

• REC opinion

  Further Information Favourable Opinion