Metabolism and EliminationPhase 1NCT01975636
An Open-label, Single Dose Study to Determine the Metabolism and Elimination of [14C]E2609 in Healthy Male Subjects
A Phase 1 study testing E2609 in people with Metabolism and Elimination, run by Eisai Inc. at 2 sites in United States.
Trial summary
This is an open-label, single dose study in healthy male subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolism and Elimination
- What is being tested?
- E2609
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2013to Mar 2014
- 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 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must meet criteria to be included in this study, including but not limited to the following:
- Healthy male 18 - 55 years, inclusive, at the time of informed consent
- Body mass index (BMI) of 18 to 32 kg/m2 at Screening
- Subjects must have had a successful vasectomy (confirmed azoospermia) or they and their female partners not be of childbearing potential or must be practicing highly effective contraception throughout the study period and for 30 days after study drug discontinuation. Sperm donation is not allowed during the study period and for 30 days after study drug discontinuation.
- Provide written informed consent
- Willing and able to comply with all aspects of the protocol
Who cannot join
- Subjects who meet any of the following criteria will be excluded from this study:
- Have participated in a 14C-research study within the 6 months prior to Day -2. The total exposure from this and any previous study must be within the recommended levels considered safe.
- Exposure to clinically significant radiation within 12 months prior to Day -2.
- Any laboratory abnormalities considered clinically significant by the investigator, which may require further investigations or treatment
- Clinically significant illness which required medical treatment within 8 weeks or a clinically significant infection within 4 weeks of dosing
- Any history of gastrointestinal surgery (e.g., hepatectomy, nephrotomy, digestive organ resection) that may affect PK profiles of study drugs
Show all 9Show fewer
- Hypersensitivity to the study drugs or any of their excipients
- Known to be human immunodeficiency virus (HIV) positive
- Restrictions will apply on prior and concomitant medications, food and beverages
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Covance Clinical Research Unit Inc.
Madison, Wisconsin, 53704
Covance Laboratories
Madison, Wisconsin, 53704
About this study
This is an open-label, single dose study in healthy male subjects.
Read the detailed description
A baseline (predose) fecal sample and a baseline (predose) urine sample will be obtained at the clinic prior to dosing on Day 1.
On Day 1, subjects will begin the Treatment Phase. Subjects will be released from the clinic after at least 10 days since dosing and as soon as the following conditions are met:
- greater than 90% of the administered radioactivity has been recovered, and
- less than 1% of the administered radioactive dose is recovered in two consecutive 24-hour samples each of urine and feces
- Conditions
- Metabolism and Elimination
- Being tested
- E2609
- Keywords
- Metabolism and Elimination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E2609Drug
Single oral 100 mg +/- 10 mg E2609 with a level of radioactive exposure consistent with the Radioactive Drug Research Committee allowance
| Study group | Role | What they receive |
|---|---|---|
| E2609 | Experimental | Single oral 100 mg +/- 10 mg E2609 with a level of radioactive exposure consistent with the Radioactive Drug Research Committee allowance Receives: Drug: E2609 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics: Elimination of E2609: urine/feces concentration
Total radioactivity will be analyzed in urine and feces predose and up to 28 days postdose.
Measured: Predose and every 24 hours postdose up to 28 days
Pharmacokinetics: Plasma concentration of E2609/metabolite
Total radioactivity will be analyzed in whole blood, plasma, and red blood cells.
Measured: Predose andup to 648 hours postdose
Secondary outcomes (1)
Pharmacokinetics: Metabolic profile of E2609: plasma/urine/feces concentration
Metabolite profiling in plasma, urine, and feces will be performed by liquid chromatography with radiodetection (radio-high performance liquid chromatography [HPLC]) methods. A scintillation counter and/or AMS will be used to detect radioactivity. If needed, plasma and feces samples will be treated with cysteine and/or other reagents before radio-HPLC analyses.
Measured: Predose andup to 648 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2013 (estimated)
- Study startJun 2013
- Primary completionNov 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolism and EliminationStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01975636
- Sponsor's protocol ID
- E2609-A001-005
- Status last verified
- Nov 2015
- First submitted
- 29 Oct 2013
- Last updated
- 8 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single Dose Study to Determine the Metabolism and Elimination of [14C]E2609 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01975636
- Acronym / sponsor ID
- E2609-A001-005
- Conditions
- Metabolism and Elimination
- Keywords
- Metabolism and Elimination
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 5 Nov 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 is an open-label, single dose study in healthy male subjects.
Detailed description
A baseline (predose) fecal sample and a baseline (predose) urine sample will be obtained at the clinic prior to dosing on Day 1.
On Day 1, subjects will begin the Treatment Phase. Subjects will be released from the clinic after at least 10 days since dosing and as soon as the following conditions are met:
- greater than 90% of the administered radioactivity has been recovered, and
- less than 1% of the administered radioactive dose is recovered in two consecutive 24-hour samples each of urine and feces
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| E2609 | Experimental | Drug: E2609Single oral 100 mg +/- 10 mg E2609 with a level of radioactive exposure consistent with the Radioactive Drug Research Committee allowance |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subjects must meet criteria to be included in this study, including but not limited to the following:
- Healthy male 18 - 55 years, inclusive, at the time of informed consent
- Body mass index (BMI) of 18 to 32 kg/m2 at Screening
- Subjects must have had a successful vasectomy (confirmed azoospermia) or they and their female partners not be of childbearing potential or must be practicing highly effective contraception throughout the study period and for 30 days after study drug discontinuation. Sperm donation is not allowed during the study period and for 30 days after study drug discontinuation.
- Provide written informed consent
Key exclusion criteria (9 listed)
- Have participated in a 14C-research study within the 6 months prior to Day -2. The total exposure from this and any previous study must be within the recommended levels considered safe.
- Exposure to clinically significant radiation within 12 months prior to Day -2.
- Any laboratory abnormalities considered clinically significant by the investigator, which may require further investigations or treatment
- Clinically significant illness which required medical treatment within 8 weeks or a clinically significant infection within 4 weeks of dosing
- Any history of gastrointestinal surgery (e.g., hepatectomy, nephrotomy, digestive organ resection) that may affect PK profiles of study drugs
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 |
|---|---|---|
| E2609Single oral 100 mg +/- 10 mg E2609 with a level of radioactive exposure consistent with the Radioactive Drug Research Committee allowance | Drug | E2609 |
Primary outcome
Pharmacokinetics: Elimination of E2609: urine/feces concentration
Time frame: Predose and every 24 hours postdose up to 28 days
Total radioactivity will be analyzed in urine and feces predose and up to 28 days postdose.
Pharmacokinetics: Plasma concentration of E2609/metabolite
Time frame: Predose andup to 648 hours postdose
Total radioactivity will be analyzed in whole blood, plasma, and red blood cells.
1 secondary outcome
Pharmacokinetics: Metabolic profile of E2609: plasma/urine/feces concentration
Time frame: Predose andup to 648 hours postdose
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 8 Jan 2016.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing E2609 in people with Metabolism and Elimination, run by Eisai Inc. at 2 sites in United States.
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 6 inclusion and 9 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 8 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Pharmacokinetics: Elimination of E2609: urine/feces concentration (time frame: Predose and every 24 hours postdose up to 28 days). The study lists 2 primary outcomes in all. 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 8 Jan 2016.