MicroADME of 14C-AB1010 in Healthy Male Subjects (QCL118054)
Research type
Research Study
Full title
An Open-Label, Non-Randomised, Single-Dose, Single-Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of 14C-AB1010 in Healthy Male Subjects
IRAS ID
228529
Contact name
Franck Pitré
Contact email
Sponsor organisation
AB Science
Eudract number
2017-001948-34
Duration of Study in the UK
0 years, 3 months, 27 days
Research summary
The Sponsor is developing the study drug, AB1010, for the potential treatment of a number of different diseases including; anti-inflammatory diseases such as mastocytosis (a build-up of a type of white blood cells), rheumatoid arthritis and crohns disease, diseases that affect the central nervous system such as Parkinson's disease, Alzheimer's disease and some forms of cancer.
Certain cells within our body send messages to other cells, the test medicine targets tome of the messages the cells in our body sends and these messages and prevents them from happening.
The study will use radiolabelled doses of the test medicine (AB1010) to identify how the test medicine is taken up, broken down and removed from the body when given orally. ‘Radiolabelled’ means that the test medicine has a radioactive component which helps us to track where the drug is in the body. The type of radioactivity used, carbon-14, is naturally occurring radioactivity that will allow us to trace the study drug in the blood and assess how much is being taken up into / broken down in the body.
The study will consist of 1 study period involving up to 6 healthy male subjects who will receive a single dose of 200mg study drug and remain resident in the clinical unit up to 7 days after dosing (day 8).
REC name
HSC REC A
REC reference
17/NI/0100
Date of REC Opinion
13 Jun 2017
REC opinion
Further Information Favourable Opinion