PK & Scintigraphic Assessment of Colistimethate Sodium (QCL117619)
Research type
Research Study
Full title
A Single-Centre, Open Label Study Consisting of a Pilot Pharmacokinetic Part and a Three-Way Cross Over Pharmacokinetic and Scintigraphic Part to Compare Colistimethate Sodium Delivered as ColistAir®, as Colobreathe®, or by eFlow® Rapid Nebuliser in Healthy Subjects
IRAS ID
194837
Contact name
Tomas Norling
Contact email
Sponsor organisation
Xellia Pharmaceuticals ApS.
Eudract number
2015-004958-17
Duration of Study in the UK
0 years, 3 months, 27 days
Research summary
The Sponsor is developing a product for inhalation (ColistAir®) using an antibiotic called colistimethate sodium (CMS), which is used to treat infection in patients with the lung disorder cystic fibrosis (CF). \n\nThe study will try to identify how the body takes up CMS when administered as ColistAir®, compared with two different inhalation products (eFlow® Rapid Nebuliser and Colobreathe®). The study will also use imaging techniques to look at how the drug is deposited in the lungs. \n\nThe study will consist of 2 parts involving up to 38 healthy male and female subjects. Part 1 will consist of up to 5 periods (Regimens A to E), in which up to 16 subjects will receive up to three doses of the study drug and doses of each of the two comparator products. Part 2 will consist of 3 periods (Regimens F to H), in which up to 22 subjects will receive one radiolabelled dose of CMS administered as ColistAir® and by eFlow® Rapid Nebuliser respectively, and one non-radiolabelled dose of CMS administered as Colobreathe®.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
15/SC/0724
Date of REC Opinion
18 Jan 2016
REC opinion
Further Information Favourable Opinion