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