Not Applicable as This is a Mass Balance/Pharmacokinetic Study Performed in Healthy SubjectsPhase 1NCT01783964
Elacytarabine Mass Balance Study in Healthy Volunteers
A Phase 1 study testing [14C]-Elacytarabine in people with Not Applicable as This is a Mass Balance/Pharmacokinetic Study Performed in Healthy Subjects, run by Clavis Pharma at 1 site in United Kingdom.
Trial summary
This study is performed to measure the quantity of i.v. applied elacytarabine that leave the body, by which route and how fast. Read more about this study
- Who is it for?
- Ages 50 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Not Applicable as This is a Mass Balance/Pharmacokinetic Study Performed in Healthy Subjects
- What is being tested?
- [14C]-Elacytarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2013to Jun 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
This study is performed to measure the quantity of i.v. applied elacytarabine that leave the body, by which route and how fast.
Read the 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.
- Conditions
- Not Applicable as This is a Mass Balance/Pharmacokinetic Study Performed in Healthy Subjects
- Being tested
- [14C]-Elacytarabine
- Keywords
- Elacytarabine, pharmacokinetic, Microdose, Mass Balance Recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]-ElacytarabineDrug
Also called elacytarabine
Single intravenous administration
| Study group | Role | What they receive |
|---|---|---|
| [14C]-Elacytarabine Microdose | Experimental | intravenous (IV) administration of one dose of elacytarabine Receives: Drug: [14C]-Elacytarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Two weeks after administration
Secondary outcomes (1)
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
Measured: Two weeks after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionFeb 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Not Applicable as This is a Mass Balance/Pharmacokinetic Study Performed in Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clavis Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01783964
- Sponsor's protocol ID
- CP4055-110
- Status last verified
- Aug 2013
- First submitted
- 1 Feb 2013
- Last updated
- 28 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01783964
- Acronym / sponsor ID
- CP4055-110
- Conditions
- Not Applicable as This is a Mass Balance/Pharmacokinetic Study Performed in Healthy Subjects
- Keywords
- Elacytarabine, pharmacokinetic, Microdose, Mass Balance Recovery
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Clavis PharmaIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Feb 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 5 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]-Elacytarabine Microdose | Experimental | Drug: [14C]-Elacytarabineintravenous (IV) administration of one dose of elacytarabine |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [14C]-ElacytarabineAlso: elacytarabineSingle intravenous administration | Drug | [14C]-Elacytarabine Microdose |
Primary outcome
mass balance of elacytarabine after i.v. dosing
Time frame: Two weeks after administration
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)
1 secondary outcome
To provide safety and tolerability information for elacytarabine given as a microdose
Time frame: Two weeks after administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [14C]-Elacytarabine in people with Not Applicable as This is a Mass Balance/Pharmacokinetic Study Performed in Healthy Subjects, run by Clavis Pharma at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mass balance of elacytarabine after i.v. dosing (time frame: Two weeks after administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2013.