CWoW - Verona RPL554-MD-201 single & repeat doses of RPL554 in COPD patients
Research type
Research Study
Full title
A PHASE II, RANDOMIZED STUDY TO ASSESS THE PHARMACOKINETICS, SAFETY AND PHARMACODYNAMICS OF SINGLE AND REPEAT DOSES OF RPL554 ADMINISTERED BY METERED DOSE INHALER IN PATIENTS WITH COPD
IRAS ID
261409
Contact name
Brian Leaker
Contact email
Sponsor organisation
Verona Pharma plc
Eudract number
2018-004896-11
Duration of Study in the UK
1 years, 0 months, 4 days
Research summary
The purpose of this study is to see how well a new drug called RPL554 works when administered as single and repeat doses for moderate to severe Chronic Obstructive Pulmonary Disease (COPD), a type of lung disease. It will also evaluate how safe the drug is and how the body processes it (called pharmacokinetics (PK)). RPL554 is a new inhaled drug being developed for the treatment of COPD and has not yet been approved for use. RPL554 appears to decrease inflammation in the lung (thought to play a role in COPD) and helps to open up lung airways (called “bronchodilation”), making it easier to breathe.
Approximately 36 participants will be enrolled at up to 3 centres in the UK. The study will consist of 2 parts. Part A has 6 different treatment arms; 5 are double blind (neither the patient nor the study doctor and their team know what dose of study drug is being administered) and 1 will be single-blind (the patient is not aware of the study treatment). Participants will be randomised equally to 1 of 6 treatment arms. A single dose of RPL554 or placebo will be administered followed by 12 hours of study assessments, including PK, safety and serial spirometry. Participants will return 24 hours post dose for assessments. The data from Part A will be unblinded (finding out the treatment arm of each patient) and analysed prior to starting Part B. Safety, PK and pharmacodynamic (what RPL554 does to the body) data will be assessed for each treatment arm to decide which dose levels should be evaluated in Part B.
In Part B, the participants from Part A will be randomly assigned to 1 of 4/5 treatment groups, each consisting of 7 days treatment, with 7 to 10 days between treatment periods. Each treatment group will include up to 4 dose levels of RPL554 administered by Pressurised metered dose inhaler (pMDI) as repeat doses (twice daily) over 4/5 treatment periods within a known range (100 up to 3000 µg), plus placebo, depending on the results from Part A. An End of Study Visit will take place 4 to 10 days after the completion of Treatment Period 4. Each participant will be in the study for between 139 and 149 days.REC name
North West - Haydock Research Ethics Committee
REC reference
19/NW/0162
Date of REC Opinion
10 Apr 2019
REC opinion
Favourable Opinion