ADME study of [14C]-Acebilustat (CTX-4430) in Healthy Males(QSC118147)
Research type
Research Study
Full title
An Open Label, Single-Dose, Single-Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-Acebilustat (CTX-4430) in Healthy Male Subjects
IRAS ID
254049
Contact name
Sanjeev Ahuja
Contact email
Sponsor organisation
Celtaxsys, Inc.
Eudract number
2018-004433-32
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 1 months, 5 days
Research summary
The Sponsor is developing the new test medicine, acebilustat, for the potential treatment of inflammatory diseases such as Cystic Fibrosis (a genetic disease that involves the lungs).
The study will try to identify the amount of radioactivity found in the blood, urine and faeces after a single dose of radiolabelled acebilustat([14C]-acebilustat). "Radiolabelled’ means that the test medicine has a radioactive component (14C) which helps us to track where and how much of the test medicine is distributed i.e. in the blood, urine and faeces. We will also look for the breakdown products of acebilustat (its' metabolites) to find out the structure of these products.
The study will involve 6 healthy male volunteers. The 6 volunteers will each receive a single dose of 100 mg of radiolabelled acebilustat as a solution to drink. Blood, urine and faecal samples will then be collected at regular intervals from each volunteer who will be resident in the clinical unit for approximately 8 days.
REC name
Wales REC 2
REC reference
19/WA/0053
Date of REC Opinion
14 Feb 2019
REC opinion
Favourable Opinion