Safety and blood levels of RV568; version1

• Research type

  Research Study

• Full title

  A randomised, double blind, placebo-controlled, two part study to evaluate the safety, tolerability and pharmacokinetics of treatment with single and repeat doses of inhaled RV568 in healthy volunteers (HMR code: 12-010)

• IRAS ID

  103375

• Contact name

  Malcolm Boyce

• Eudract number

  2011-004971-36

• ISRCTN Number

  ISRCTN

• Research summary

  RV568 is an experimental new medicine to treat chronic obstructive pulmonary disease (COPD). Patients with COPD have inflamed and narrowed lung airways, which causes coughing, difficulty breathing, and attacks of wheezing and breathlessness. RV568 may be useful in the treatment of COPD by blocking substances that cause inflammation. A liquid form of RV568, in a nasal spray or inhaler, has already been tested in people. We will test a new powder form of RV568 in an inhaler, to find out if it has any side effects, how much gets into the bloodstream and how long it stays there. This study in healthy adults is in 2 parts: A and B.Part A (single doses) 10 volunteers will have 5 study sessions and take 4 single doses of study medicine and 1 dose of dummy medicine. They will stay on the ward for 2 nights in each session, and make 5 outpatient visits in total. They will take up to 12 weeks to finish the study. 2 groups of 8 volunteers each will take a single dose of RV586 or dummy medicine. They will stay on the ward for 2 nights, make 4 outpatient visits and will take up to 7 weeks to finish the study. Part B (repeated doses) 2 groups of 12 volunteers each will take 14 daily doses of RV568, or dummy medicine. They will stay on the ward for 15 nights and make 4 outpatient visits. They will take up to 9 weeks to finish the study. In each part of the study, we will start with a small dose, and increase the dose as the study progresses. A pharmaceutical company (RespiVert Ltd.) is paying for the study. The study will take place at 1 centre in London. We will recruit healthy volunteers by word of mouth, volunteer databases and our websites.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  12/LO/0429

• Date of REC Opinion

  4 Apr 2012

• REC opinion

  Favourable Opinion