Quotient Clinical announces the novel application of a 14C microdose study to establish the mass balance of Elacytarabine in healthy subjects
16 July 2013 – Quotient Clinical, a business unit of Quotient Bioresearch (“Quotient”) today announced the completion of a 14c microdose study to establish the mass balance of elacytarabine in healthy subjects. The study was conducted together with Clavis Pharma.
The program of work was delivered via Quotient’s Synthesis-to-Clinic™ platform, from the radiosynthesis of the 14c
API through to the final study report. The clinical study was an open label, single-dose study to assess the mass balance recovery of an intravenous microdose of 14C-elacytarabine and involved the first dosing of elacytarabine, a cytotoxic molecule, to healthy male subjects.
The study requirement was driven by a specific request from the US Food and Drug Administration (FDA) to provide information on the routes of elimination of total radioactivity and total recovery. The study synopsis was reviewed by FDA before submission to the MHRA and implementation at Quotient’s UK-based clinic. By performing the study in healthy subjects Clavis Pharma were able to avoid the complications of extended recruitment periods and potential inconsistency in compliance of a study in patients.
Mark Egerton, Managing Director of Quotient Clinical, commented:
“This study with Clavis highlights our ability to provide innovative clinical solutions to drug development challenges through our integrated 14C Synthesis-to-Clinic platform.”
Athos Gianella-Borradori, MD, Chief Medical Officer of Clavis Pharma, commented: “The cooperation with Quotient, who delivered this program using their Synthesis-to-Clinic platform, was very effective. We are confident that studies performed at such high standards can help clarify important aspects of drug distribution and can fully meet the expectations of regulatory agencies”