Elacytarabine Mass Balance Study in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Clavis Pharma
ClinicalTrials.gov Identifier:
NCT01783964
First received: February 1, 2013
Last updated: August 27, 2013
Last verified: August 2013
  Purpose

This study is performed to measure the quantity of i.v. applied elacytarabine that leave the body, by which route and how fast.


Condition Intervention Phase
Not Applicable as This is a Mass Balance/Pharmacokinetic Study Performed in Healthy Subjects
Drug: [14C]-Elacytarabine
Phase 1

Study Type: Interventional
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

Further study details as provided by Clavis Pharma:

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    Blood samples for determination of total radioactivity in whole blood will be withdrawn at pre dose, 3 h, 9 h, 24 h, 48 h, 72 h, 96 h, 120 h, 144 h and 168 h post-dose and at admission on Days 10 and 14.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



Secondary Outcome Measures:
  • 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


Enrollment: 6
Study Start Date: February 2013
Study Completion Date: June 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: [14C]-Elacytarabine Microdose
intravenous (IV) administration of one dose of elacytarabine
Drug: [14C]-Elacytarabine
Single intravenous administration
Other Name: elacytarabine

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

Ages Eligible for Study:   50 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01783964

Locations
United Kingdom
Quotient Clinical
Ruddington, Nottngham, United Kingdom, NG11 6JS
Sponsors and Collaborators
Clavis Pharma
  More Information

No publications provided

Responsible Party: Clavis Pharma
ClinicalTrials.gov Identifier: NCT01783964     History of Changes
Other Study ID Numbers: CP4055-110
Study First Received: February 1, 2013
Last Updated: August 27, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Clavis Pharma:
Elacytarabine
pharmacokinetic
Microdose
Mass Balance Recovery

Additional relevant MeSH terms:
Cytarabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014