CHF6001 mass balance study
Research type
Research Study
Full title
Evaluation of the Absolute Bioavailability and Mass Balance of CHF6001 Following a Single Inhaled Dose Co-Administered With an Intravenous Radiolabelled Microtracer Dose in Healthy Volunteers
IRAS ID
282799
Contact name
Ashley Brooks
Contact email
Sponsor organisation
Chiesi Farmaceutici
Eudract number
2020-004201-31
Clinicaltrials.gov Identifier
20/NE/0155, REC Ref
Duration of Study in the UK
0 years, 1 months, 20 days
Research summary
The purpose of the planned study is to investigate a drug (CH6001) being developed by the study sponsor as a potential inhalational treatment for chronic obstructive lung disease (COPD), a disease associated with chronic inflammation.
The study will be conducted in healthy male subjects at a single site, Covance Clinical Research Leeds and will enroll a total of 8 healthy male subjects. Phosphodiesterase-4 (PDE4) is an enzyme that mediates the breakdown of cyclic adenosine monophosphate (cAMP), with PDE4 inhibition having anti-inflammatory effects.
This study will evaluate the absolute bioavailability and mass balance of the study drug CHF6001 following the administration of a single inhaled dose co-administered with an intravenous radiolabelled microtracer dose which will be administered as 4 inhalations of the study medication CH6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg). This will be co-administered with an intravenous micro dose (18.5µg and 500nCi (18.5kBq)) of [14C]-labelled CHF6001.
Subjects will be enrolled into this study once their eligibility has been confirmed prior to admission. Subjects will be trained in the use of the inhalation device, at the screening visit, on Day-1 and Day 1 following admission to the unit. Subjects will be admitted to the study site on Day-1, and will be dosed in accordance with the study protocol on Day 1 intravenously and using the DPI device following which the subjects will remain on site until the morning of day 11.
The subjects will be discharged following the 240-hour post dose assessments have been completed.
There will be a follow up phone call performed 7-10 days following discharge from the study site. Blood samples as well as urine and faecal samples will be collected up to 241.75 hours.REC name
North East - York Research Ethics Committee
REC reference
20/NE/0155
Date of REC Opinion
10 Dec 2020
REC opinion
Favourable Opinion