Elacytarabine Mass Balance Study in Healthy Volunteers

Not Applicable as This is a Mass Balance/Pharmacokinetic Study Performed in Healthy Subjects Clinical Trial

Official 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

Status Completed

Clinical Trial Summary

This study is performed to measure the quantity of i.v. applied elacytarabine that leave the body, by which route and how fast.

Clinical Trial Description

This is a single centre, open-label, non-randomised single dose study in healthy male subjects. Each subject will receive a single 15 min IV administration of 14C labelled elacytarabine.

In this study, at least 6 subjects will be dosed in order to obtain data in 4 evaluable subjects. ;

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Not Applicable as This is a Mass Balance/Pharmacokinetic Study Performed in Healthy Subjects

• NCT number: NCT01783964
• Study type: Interventional
• Source: Clavis Pharma
• Status: Completed
• Phase: Phase 1
• Start date: February 2013
• Completion date: June 2013