An investigation of QVA149 in healthy volunteers

• Research type

  Research Study

• Full title

  A double-blind, randomized, placebo and active drug controlled, incomplete cross-over study to investigate the secondary pharmacodynamic effects, the pharmacokinetics, safety and tolerability of QVA149 in healthy volunteers

• IRAS ID

  82849

• Contact name

  Salvatore Febbraro

• Sponsor organisation

  Novartis Pharmaceuticals UK Limited

• Eudract number

  2011-002197-23

• ISRCTN Number

  1

• Research summary

  The purpose of this study is to investigate the effects of a new drug called QVA149, which is being developed for the treatment of a disease which affects the lungs, called chronic obstructive pulmonary disease (or COPD as it is known). QVA149 is an inhaled treatment and it works by widening the airways to the lungs and can therefore be helpful in the treatment of patients with COPD, since it helps them breathe more easily. QVA149 has already been tested in a number of healthy volunteers as well as patients with COPD and has proved to be safe and well tolerated. In this study, the effects of QVA149 on heart rate will be investigated over a 24 hour period. These effects will also be compared to those seen when other treatments are given instead of QVA149. The alternative treatments are drugs called: QAB149, NVA237 and Salmeterol, a placebo treatment may also be given. At each of the treatment visits subjects will receive a different inhaled treatment according to a pre-determined treatment sequence. Subjects will be randomized on Day 1 of Treatment Period 1 and will receive a different treatment at each of the 3 treatment periods from the following:?½QVA149, ?½QAB149, ?½NVA237, ?½Salmeterol,?½Placebo.Heart rate will be monitored using continuous holter monitoring and 12 lead ECGs. Other safety parameters will also be measured at pre-determined time-points during the study including blood pressure and pulse. Adverse events will be monitored throughout the study. Blood samples will also be taken to measure the levels of drug, potassium and glucose in the blood.

• REC name

  Wales REC 2

• REC reference

  11/WA/0169

• Date of REC Opinion

  17 Jun 2011

• REC opinion

  Favourable Opinion