Elacytarabine Mass Balance Study in Healthy Volunteers

NCT01783964 | Completed Phase 1

• 1 other identifier: CP4055-110
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Elacytarabine; pharmacokinetic; Microdose; Mass Balance Recovery

Outcome Measures

Primary Outcomes (1)

• 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  Blood samples for determination of total radioactivity in whole blood will be withdrawn at pre dose, 3 h, 9 h, 24 h, 48 h, 72 h, 96 h, 120 h, 144 h and 168 h post-dose and at admission on Days 10 and 14.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 (1)

• To provide safety and tolerability information for elacytarabine given as a microdose

  Two weeks after administration

Study Arms (1)

[14C]-Elacytarabine Microdose

EXPERIMENTAL

intravenous (IV) administration of one dose of elacytarabine

Drug: [14C]-Elacytarabine

Interventions

[14C]-Elacytarabine DRUG

Single intravenous administration

Also known as: elacytarabine

[14C]-Elacytarabine Microdose

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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

You may not qualify if:

• 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
• \. 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

Sponsors & Collaborators

• Clavis Pharma: lead

Study Sites (1)

Quotient Clinical

Ruddington, Nottngham, NG11 6JS, United Kingdom

Location

MeSH Terms

Interventions

5'-oleoyl cytarabine

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2013
• First Posted: February 5, 2013
• Study Start: February 1, 2013
• Primary Completion: February 1, 2013
• Study Completion: June 1, 2013
• Last Updated: August 28, 2013

Record last verified: 2013-08

Locations

GB (1)