ADME study of [14C]-A4250 in healthy male subjects (QCL117743)
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]-A4250 in Healthy Male Subjects
IRAS ID
212083
Contact name
Terese Wallefors
Contact email
Sponsor organisation
Albireo AB
Eudract number
2016-002923-27
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 1 months, 13 days
Research summary
The Sponsor is developing the study drug, A4250, for the potential treatment of a rare set of liver diseases, referred to as orphan cholestatic liver diseases, which are caused by a build-up of bile in the liver. The liver makes and releases bile acids into the intestine to aid digestion of fat from food and to aid the removal of digestive waste products. Bile acids are recycled by moving back into the liver. It is hoped that the study drug, A4250, will work by preventing the movement of bile acids back into the liver, so preventing the excess build-up in patients with cholestatic liver diseases.
The study will be carried out in six healthy male subjects to measure how the study drug, A4250, is taken up, broken down and removed by the body. The break down products of A4250 will also be identified.
The study will consist of a single study period where all six subjects will receive a single dose of 3 mg of radiolabelled A4250 ([14C]-A4250) as a capsule by mouth. ‘Radiolabelled’ means that the study drug has a radioactive component which enables researchers to track where the study drug is in the body. Subjects will remain resident in the clinical unit for a maximum of ten days during which blood, urine and faecal samples will be collected at regular intervals.
REC name
HSC REC A
REC reference
16/NI/0254
Date of REC Opinion
16 Dec 2016
REC opinion
Favourable Opinion