ADME study of [14C]-BLU-5937 in healthy male volunteers (QSC202496)
Research type
Research Study
Full title
A Single Dose Study to Assess the Mass Balance Recovery, Absorption, Metabolism and Excretion of [14C]-BLU-5937 in Healthy Male Subjects After Oral Dosing
IRAS ID
278023
Contact name
Nathalie Chautet
Contact email
Sponsor organisation
BELLUS Health Inc.
Eudract number
2020-000184-22
Duration of Study in the UK
0 years, 1 months, 8 days
Research summary
The sponsor is developing the test medicine, BLU-5937, for the treatment of unexplained or refractory chronic cough. Refractory or unexplained chronic cough is defined as a cough that lasts for 8 weeks or more, where an underlying cause is not identified or a cough resistant to the treatment of the underlying disease. This type of cough is thought to be due to the activation of a certain type of receptor in the upper airways which sends a signal of irritation to the brain that translates into an urge-to-cough. BLU-5937 has the potential to block the ability of the receptor to activate coughing reflex.\n\nThe study involves radiolabelling (labelling the molecule with radioactive 14C) which is used to locate the molecule within the body. The study will try to assess how much radioactivity can be recovered from the blood, urine and faeces (mass balance recovery) after a single oral dose of [14C]-BLU-5937. It will also look to identify the breakdown products (metabolites) of the parent drug. It will additionally determine the rate and route of elimination of [14C]-BLU-5937, along with the level of test medicine in the blood. The safety and tolerability of the test medicine will be assessed. \n\nThe study will consist of 1 study period involving up to 6 healthy male volunteers. Up to 6 volunteers will receive a dose of 100 mg of the radiolabelled test medicine as 2 capsules. Blood, urine and faecal samples will be collected from volunteers whilst they are resident in the clinical unit for up to 168 hours (Day 8). If the required level of radioactivity has not been recovered by this point, the residency period may be extended up to Day 10. \n
REC name
London - Surrey Borders Research Ethics Committee
REC reference
20/LO/0396
Date of REC Opinion
6 Apr 2020
REC opinion
Favourable Opinion