Microdose Study Establishes Mass Balance of Elacytarabine

Jul 15, 2013
By PharmTech Editors

Quotient Clinical, a business unit of Quotient Bioresearch, announced the completion of a 14C microdose study with Clavis Pharma, to establish the mass balance of elacytarabine in healthy subjects. 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 request from the US Food and Drug Administration (FDA) to provide information on the routes of elimination of total radioactivity and total recovery.  By performing the study in healthy subjects, Clavis Pharma was able to avoid the complications of extended recruitment periods and potential inconsistency in compliance of a study in patients, according to a company press release.