To assess the effects of inhaled RPL554 in adults with cystic fibrosis
Research type
Research Study
Full title
A Phase IIa, randomised, double blind, placebo controlled, three way crossover study to assess the pharmacokinetics of RPL554 administered to adult patients with Cystic Fibrosis.
IRAS ID
199081
Contact name
Katharine Abbott-Banner
Contact email
Sponsor organisation
Verona Pharma plc
Eudract number
2015-004263-36
Duration of Study in the UK
0 years, 4 months, 0 days
Research summary
This Phase IIa study trials RPL554 (an inhaled phosphodiesterase 3/4 inhibitor) developed by Verona Pharmaceuticals. The main (primary) objective of the study is to measure how two different doses of inhaled RPL554 (1.5mg and 6mg) are ‘biologically’ handled by patients with cystic fibrosis (CF); specifically, this pertains to the biological mechanisms employed by the body which influence how RPL554 is absorbed, distributed, broken-down and finally excreted (processes collectively termed as ‘pharmacokinetics’). Other objectives of the study refer to the effects of RPL554 on the lung function and inflammation levels in CF patients. Additional objectives are to assess safety and tolerability in this patient population.
The study employs a randomised, double blind, placebo controlled, (complete block) three way crossover design. It is planned to enrol sufficient patients to ensure that 10 complete all three treatment periods at one centre (The Cambridge Centre for Lung Infection, Papworth Hospital, Cambridge, UK).
REC name
London - West London & GTAC Research Ethics Committee
REC reference
16/LO/1766
Date of REC Opinion
7 Dec 2016
REC opinion
Further Information Favourable Opinion