NCT01783964

Elacytarabine Mass Balance Study in Healthy Volunteers

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Clavis Pharma · Industry
• Sex: Male
• Age: 50 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
DRUG	[14C]-Elacytarabine	Single intravenous administration

Timeline

• Start date: 2013-02-01
• Primary completion: 2013-02-01
• Completion: 2013-06-01
• First posted: 2013-02-05
• Last updated: 2013-08-28

Locations

1 site across 1 country: United Kingdom