- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Ruddington, Nottngham, United Kingdom, NG11 6JS
- Quotient Clinical
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- Participation in a clinical research study within the previous 3 months
- Subjects who are study site employees, or immediate family members of a study site or sponsor employee
- Subjects who have previously been enrolled in this study or in any other elacytarabine study
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: [14C]-Elacytarabine Microdose
intravenous (IV) administration of one dose of elacytarabine
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Single intravenous administration
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
mass balance of elacytarabine after i.v. dosing
Time Frame: Two weeks after administration
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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) |
Two weeks after administration
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To provide safety and tolerability information for elacytarabine given as a microdose
Time Frame: Two weeks after administration
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Two weeks after administration
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CP4055-110
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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