A Phase Ib, multicentre, double blind, randomized, two-part study, first part multiple rising dose and second part two-way cross-over

• Research type

  Research Study

• Full title

  A Phase Ib, multicentre, double blind, randomized, two-part study, first part multiple rising dose and second part two-way cross-over, to assess safety, tolerability, efficacy and pharmacokinetics of BI 443651 compared to placebo via Respimat® in healthy volunteers and CF subjects.

• IRAS ID

  211638

• Contact name

  Dave Singh

• Contact email

  dsingh@meu.org.uk

• Sponsor organisation

  Boehringer Ingelheim

• Eudract number

  2016-001504-31

• Duration of Study in the UK

  1 years, 0 months, 27 days

• Research summary

  This is a two part phase 1b study to investigate the safety, tolerability, efficacy and pharmacokinetics (the action of drugs in the body over a period of time) of inhaled BI 443651 compared to placebo. A placebo is a substance that looks like the investigational drug but contains no active drug.

  Part one of this study is a multiple rising-dose design and will involve healthy volunteers and subjects with Chronic Obstructive Pulmonary Disease (COPD). This is followed by a cross-over part (part 2) involving subjects with cystic fibrosis. The study is sponsored by Boehringer Ingelheim, a pharmaceutical company.

• REC name

  East of England - Cambridge Central Research Ethics Committee

• REC reference

  16/EE/0536

• Date of REC Opinion

  9 Feb 2017

• REC opinion

  Further Information Favourable Opinion