CHF6302 - Phase 1 study in healthy volunteers
Research type
Research Study
Full title
An Open Label, Randomized, Repeated-Dose, 3-way Crossover Study to Investigate the Pharmacokinetic Interaction and the Safety of Inhaled CHF 5259 (glycopyrronium bromide) and CHF 6001 Administered in Healthy Subjects via a Multidose Reservoir NEXThaler® Dry Powder Inhaler.
IRAS ID
192690
Contact name
Ronnie Beboso
Contact email
Sponsor organisation
Quintiles Ltd.
Eudract number
2015-003161-28
Duration of Study in the UK
0 years, 11 months, 13 days
Research summary
CHF 5259 and CHF 6001 are being developed by Chiesi Farmaceutici S.p.A., (the Sponsor, a pharmaceutical company based in Parma, Italy) and this study is being carried out on behalf of the Sponsor by Quintiles.
CHF 5259 and CHF 6001 are drugs that may be useful in the treatment of chronic obstructive pulmonary disease (COPD). COPD is a type of lung disease that blocks airflow to the lungs and makes it difficult to breathe.
The purpose of this study is to examine how CHF 5259 and CHF 6001 interact with each other in the body, the safety, tolerability and the way the body handles (absorbs, distributes, breaks down and excretes) CHF 5259 and CHF 6001, when taken separately or when administered together.
This study is open label (the subjects, Investigator and Sponsor will all know what drug the subject is being given). The study will only involve healthy volunteers. CHF 6001 and the active substance found in CHF 5259 have both been given to humans before.
The study is not expected to last longer than 23 weeks. This will consist of three treatment periods, during each treatment period the subject will be admitted to the clinical unit for 18 days and 17 nights. Each period will be separated by a washout period of 21-24 days. There will be a follow up visit 9-11 days after Day 16 of the final treatment period (Period 3).
REC name
HSC REC B
REC reference
15/NI/0225
Date of REC Opinion
17 Nov 2015
REC opinion
Favourable Opinion