ADME study of [14C]-Pracinostat in Healthy Male Subjects (QCL118140)
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]-Pracinostat in Healthy Male Subjects
IRAS ID
237009
Contact name
Tatiana Caccia
Contact email
Sponsor organisation
Helsinn Healthcare SA
Eudract number
2017-004390-13
Duration of Study in the UK
0 years, 1 months, 3 days
Research summary
The sponsor, Helsinn Healthcare SA is developing a new test medicine Pracinostat for the treatment of advanced diseases of the blood such as acute myeloid leukaemia, myelodysplastic syndrome and myelofibrosis. These are a group of cancers that originate in the bone marrow and disrupt the body’s normal production of blood cells, i.e. white blood cells (causing infections), red cells (causing anemia) and platelets (causing bleeding).
The study will try to identify the amount of radioactivity found in the blood, urine and faeces after a single dose of radiolabelled Pracinostat ([14C]- Pracinostat). "Radiolabelled’ means that the test medicine has a radioactive component which helps us to track where the test medicine is ie in the blood, urine and faeces. We will also look for the breakdown products of Pracinostat (it’s 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 60 mg of radiolabelled Pracinostat as a solution to be drunk. 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
HSC REC A
REC reference
17/NI/0242
Date of REC Opinion
27 Dec 2017
REC opinion
Favourable Opinion