ADME study of [14C]-RPC1063 in healthy male subjects (QCL117686)
Research type
Research Study
Full title
A Phase I, Single-Centre, Single Dose Oral Excretion Balance Study of [14C]-RPC1063 in Healthy Male Adults
IRAS ID
213826
Contact name
Jonathan Tran
Contact email
Sponsor organisation
Celgene International II Sàrl
Eudract number
2016-003073-18
Duration of Study in the UK
0 years, 1 months, 5 days
Research summary
The Sponsor is developing the study drug Ozanimod (RPC1063), for the potential treatment of adult patients with relapsing multiple sclerosis (RMS). RMS refers to attacks of a condition which can affect the brain and/or spinal cord, causing a wide range of potential symptoms, including problems with vision, arm or leg movement, sensation or balance. The study drug Ozanimod will also be a potential treatment for adult patients with moderately to severely active inflammatory bowel disease, including ulcerative colitis (UC) and Crohn’s disease (CD). These conditions cause discomfort of the gut.
The study will try to identify the routes and rate of removal of the study drug from the body as well as the amount of radioactivity found in blood, urine and faecal samples after a single dose.
The study will consist of a single Part involving up to 6 healthy male subjects. The subjects will receive a dose of 1mg Ozanimod which is radiolabelled. ‘Radiolabelled’ means that the test drug has a radioactive component which helps us to track where the drug is in the body. Samples of blood, urine and faecal samples will be taken throughout the study to look at the concentrations of the radiolabelled drug in the body.
REC name
Wales REC 2
REC reference
16/WA/0261
Date of REC Opinion
29 Sep 2016
REC opinion
Further Information Favourable Opinion