Assessment of mass balance recovery of [14C]-Elacytarabine (QBR112387)
Research type
Research Study
Full title
An Open Label, Single-Dose Study Designed to Assess the Mass Balance Recovery of an Intravenous Microdose of [14C]-Elacytarabine in Healthy Male Subjects
IRAS ID
117842
Contact name
Stuart Mair
Sponsor organisation
Clavis Pharma
Eudract number
2012-004161-40
Research summary
The study drug, Elacytarabine is being developed by the Sponsor for the treatment of patients with haematological malignancies (cancers of the blood cells, bone marrow and lymph nodes). The purpose of the study is to look at how a radiolabelled microdose of Elacytarabine is taken up, broken down and removed from the body when given as an intravenous infusion. ??Radiolabelled?? means that the test drug has a radioactive addition which helps us to track the drug as it moves through and out of the body. In this study 6 healthy male subjects will receive a single 15 minute intravenous infusion of the study drug which has been radiolabelled. Blood, urine and faecal samples will be collected at intervals after administration of the drug to determine the amount of radioactivity present. Safety and tolerability information for elacytarabine given as a microdose will also be collected. This study is performed to fulfil regulatory requirements, and the study results will be included in the documentation to support a Marketing Authorisation Application/New Drug Application.
REC name
HSC REC A
REC reference
12/NI/0171
Date of REC Opinion
5 Dec 2012
REC opinion
Favourable Opinion