Elacytarabine Mass Balance Study in Healthy Volunteers
This study is performed to measure the quantity of i.v. applied elacytarabine that leave the body, by which route and how fast.
Not Applicable as This is a Mass Balance/Pharmacokinetic Study Performed in Healthy Subjects
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|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|
- mass balance of elacytarabine after i.v. dosing [ Time Frame: Two weeks after administration ] [ Designated as safety issue: No ]
Blood samples for determination of total radioactivity in whole blood will be withdrawn at pre dose, 3 h, 9 h, 24 h, 48 h, 72 h, 96 h, 120 h, 144 h and 168 h post-dose and at admission on Days 10 and 14.
No pharmacokinetic parameter estimations will be performed on the whole blood total radioactivity data.
Urine samples will be collected daily for Days 1 to 7 (i.e., ending on the morning of Day 8) and for a 24 h period on Days 10 and 14. On Day 1, urine collections will be pre dose, 0 to 6, 6 to 12 and 12 to 24 h post dose. Thereafter collections will be for 24 h periods Faecal samples will be collected pre-dose and daily for Days 1 to 7 (i.e., ending on the morning of Day 8), 10 and 14 (wherever possible)
- To provide safety and tolerability information for elacytarabine given as a microdose [ Time Frame: Two weeks after administration ] [ Designated as safety issue: Yes ]
- Clinical chemistry, haematology and urinalysis assessments will be performed at screening, pre-dose, 168 h post-dose and at admission on Day 14
- Electrocardiograms (ECG) will be performed at screening, admission on Day -1, and at 4 h and 168 h post-dose.
- Vital signs (heart rate and blood pressure) will be performed at screening, admission on Day -1, pre-dose, at the end of the infusion and at 1 h, 4 h, 24 h and 168 h post-dose.
- Temperature will be performed on admission on Day -1 and pre-dose.
- Physical examinations will be performed at screening.
- Drugs of abuse tests, and alcohol and carbon monoxide breath tests will be performed at screening and at admission on Day -1.
- Subjects will be tested for hepatitis B, hepatitis C and human immunodeficiency virus at screening.
- Adverse events (AEs) will be monitored throughout the study. Any AEs that are ongoing at discharge from the study on Day 15 will be followed up until stable or resolution
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
Experimental: [14C]-Elacytarabine Microdose
intravenous (IV) administration of one dose of elacytarabine
Single intravenous administration
Other Name: elacytarabine
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.