Clinical trial NCT01783964: Elacytarabine Mass Balance Study in Healthy Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Not Applicable as This is a Mass Balance/Pharmacokinetic Study Performed in Healthy Subjects
Keywords: Elacytarabine
pharmacokinetic
Microdose
Mass Balance Recovery
Lead sponsor: Clavis Pharma
Sponsor class: INDUSTRY
First posted: 2013-02-05
Enrollment: 6
Sex: MALE
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Healthy males 2. Age 50 to 65 years of age 4. Must be willing and able to communicate and participate in the whole study 5. Must provide written informed consent 6. Must agree to use an adequate method of contraception

Exclusion Criteria:

1. Participation in a clinical research study within the previous 3 months
2. Subjects who are study site employees, or immediate family members of a study site or sponsor employee
3. Subjects who have previously been enrolled in this study or in any other elacytarabine study
4. History of any drug or alcohol abuse in the past 2 years

7. Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study 8. Subjects who do not have suitable veins for multiple venepunctures and IV administration as assessed by the investigator at screening 9. Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator 10. Positive drugs of abuse test result 11. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results 12. History of cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease as judged by the investigator 13. Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients 14. Presence or history of allergy requiring treatment. Hayfever is allowed unless it is active 15. Donation or loss of greater than 400 mL of blood within the previous 3 months 16. Subjects who are taking, or have taken, any prescribed or over-the-counter drug (other than 4 g per day paracetamol) or herbal remedies in the 14 days before IMP administration 17. Failure to satisfy the investigator of fitness to participate for any other reason

Primary outcomes:
measure: mass balance of elacytarabine after i.v. dosing
timeFrame: Two weeks after administration
Secondary outcomes:
measure: To provide safety and tolerability information for elacytarabine given as a microdose
timeFrame: Two weeks after administration
Other outcomes:
Locations:
city: Ruddington, Nottngham
country: United Kingdom
facility: Quotient Clinical
Study officials:
References: