Elacytarabine Mass Balance Study in Healthy Volunteers | NCT01783964

NCT01783964

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Label	Type	Description	Intervention Names
[14C]-Elacytarabine Microdose	Experimental	intravenous (IV) administration of one dose of elacytarabine	Drug: [14C]-Elacytarabine

Name	Type	Description	Arm Group Labels	Other Names
[14C]-Elacytarabine	Drug	Single intravenous administration	[14C]-Elacytarabine Microdose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
mass balance of elacytarabine after i.v. dosing	Blood samples for determination of total radioactivity in whole blood will be withdrawn at pre dose, 3 h, 9 h, 24 h, 48 h, 72 h, 96 h, 120 h, 144 h and 168 h post-dose and at admission on Days 10 and 14.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

Secondary Outcomes

Measure	Description	Time Frame
To provide safety and tolerability information for elacytarabine given as a microdose	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

Eligibility Module

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:

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