Healthy SubjectsPhase 1NCT02116907
An Open-Label, Single-Dose Study to Determine the Metabolism and Elimination of 14C-Perampanel in Healthy Male Subjects
A Phase 1 study testing E2007 in people with Healthy Subjects, run by Eisai Inc. at 1 site in United States.
Trial summary
This is an open-label, single-dose study in healthy male subjects. The study will have 2 phases: Pretreatment and Treatment. The Pretreatment Phase will last up to 21 days and will consist of a Screening Period and a Baseline Period, during which each subject's study eligibility will be determined and baseline… 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
- Healthy Subjects
- What is being tested?
- E2007
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Sep 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
- Healthy male 18 to 55 years, inclusive, at the time of informed consent
- Body mass index (BMI) of 18 to 30 kg/m2, inclusive, at Screening
- Must have had a successful vasectomy (confirmed azoospermia) or they and their female partners must not be of childbearing potential or must be practicing highly effective contraception throughout the study period and for 90 days after study drug discontinuation. No sperm donation is allowed during the study period and for 90 days after study drug discontinuation.
- Provide written informed consent
- Willing and able to comply with all aspects of the protocol
Who cannot join
- Participated in a 14C research study within the 6 months before Day-2. The total exposure from this and any previous study must be within the recommended levels considered safe (per 21 Code of Federal Regulations [CFR] 361.1)
- Exposure to clinically significant radiation within 12 months before Day-2
- Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical attention within 4 weeks of dosing
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Unit Inc.
Madison, Wisconsin, 53704
About this study
This is an open-label, single-dose study in healthy male subjects. The study will have 2 phases: Pretreatment and Treatment. The Pretreatment Phase will last up to 21 days and will consist of a Screening Period and a Baseline Period, during which each subject's study eligibility will be determined and baseline assessments will be conducted.
- Conditions
- Healthy Subjects
- Being tested
- E2007
- Keywords
- Healthy, Male Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E2007Drug
14C-labeled perampanel dissolved in ethanol and administered using a capsule formulation in a single dose, one day
| Study group | Role | What they receive |
|---|---|---|
| Perampanel | Experimental | 14C-labeled perampanel dissolved in ethanol and administered using a capsule formulation in a single dose, one day Receives: Drug: E2007 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mass balance recovery of 14C as a cumulative percent of the radiolabeled dose and the identification and quantification of metabolites in humans in vivo after administration of a single dose of radiolabeled 14C-perampanel in healthy male subjects.
These will be guided by analysis of 14C-perampanel, perampanel, and metabolites in the biological matrices.
Measured: Approximately 14 Weeks
Pharmacokinetics of total radioactivity and E2007: Maximum observed concentration (Cmax)
Measured: Approximately 14 Weeks
Pharmacokinetics of total radioactivity and E2007: time to reach maximum (peak) concentration following drug administration (tmax)
Measured: Approximately 14 Weeks
Pharmacokinetics of total radioactivity and E2007: AUC(0-24h)
Area under the concentration x time curve from time 0 to 24 hours
Measured: Approximately 14 Weeks
Pharmacokinetics of total radioactivity and E2007: AUC(0-t)
Area under the concentration x time curve from time 0 to time of last measurable concentration
Measured: Approximately 14 Weeks
Pharmacokinetics of total radioactivity and E2007: AUC(0-inf)
Area under the concentration x time curve from time 0 to infinity
Measured: Approximately 14 Weeks
Pharmacokinetics of total radioactivity and E2007: terminal elimination half-life (t1/2)
Measured: Approximately 14 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionJul 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- 7 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
- NCT02116907
- Sponsor's protocol ID
- E2007-A001-049
- Other IDs
- 2010-018518-56
- Status last verified
- Nov 2015
- First submitted
- 14 Apr 2014
- Last updated
- 3 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. 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-Perampanel in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02116907
- Acronym / sponsor ID
- E2007-A001-049
- Conditions
- Healthy Subjects
- Keywords
- Healthy, Male Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 17 Apr 2014 (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. The study will have 2 phases: Pretreatment and Treatment. The Pretreatment Phase will last up to 21 days and will consist of a Screening Period and a Baseline Period, during which each subject's study eligibility will be determined and baseline assessments will be conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Perampanel | Experimental | Drug: E200714C-labeled perampanel dissolved in ethanol and administered using a capsule formulation in a single dose, one day |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male 18 to 55 years, inclusive, at the time of informed consent
- Body mass index (BMI) of 18 to 30 kg/m2, inclusive, at Screening
- Must have had a successful vasectomy (confirmed azoospermia) or they and their female partners must not be of childbearing potential or must be practicing highly effective contraception throughout the study period and for 90 days after study drug discontinuation. No sperm donation is allowed during the study period and for 90 days after study drug discontinuation.
- Provide written informed consent
- Willing and able to comply with all aspects of the protocol
Key exclusion criteria (3 listed)
- Participated in a 14C research study within the 6 months before Day-2. The total exposure from this and any previous study must be within the recommended levels considered safe (per 21 Code of Federal Regulations [CFR] 361.1)
- Exposure to clinically significant radiation within 12 months before Day-2
- Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical attention within 4 weeks of dosing
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 |
|---|---|---|
| E200714C-labeled perampanel dissolved in ethanol and administered using a capsule formulation in a single dose, one day | Drug | Perampanel |
Primary outcome
Mass balance recovery of 14C as a cumulative percent of the radiolabeled dose and the identification and quantification of metabolites in humans in vivo after administration of a single dose of radiolabeled 14C-perampanel in healthy male subjects.
Time frame: Approximately 14 Weeks
These will be guided by analysis of 14C-perampanel, perampanel, and metabolites in the biological matrices.
Pharmacokinetics of total radioactivity and E2007: Maximum observed concentration (Cmax)
Time frame: Approximately 14 Weeks
Pharmacokinetics of total radioactivity and E2007: time to reach maximum (peak) concentration following drug administration (tmax)
Time frame: Approximately 14 Weeks
Pharmacokinetics of total radioactivity and E2007: AUC(0-24h)
Time frame: Approximately 14 Weeks
Area under the concentration x time curve from time 0 to 24 hours
Pharmacokinetics of total radioactivity and E2007: AUC(0-t)
Time frame: Approximately 14 Weeks
Area under the concentration x time curve from time 0 to time of last measurable concentration
Pharmacokinetics of total radioactivity and E2007: AUC(0-inf)
Time frame: Approximately 14 Weeks
Area under the concentration x time curve from time 0 to infinity
Pharmacokinetics of total radioactivity and E2007: terminal elimination half-life (t1/2)
Time frame: Approximately 14 Weeks
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 3 Nov 2015.
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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.
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 E2007 in people with Healthy Subjects, run by Eisai Inc. at 1 site 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 5 inclusion and 3 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 3 Nov 2015. 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 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?
Mass balance recovery of 14C as a cumulative percent of the radiolabeled dose and the identification and quantification of metabolites in humans in vivo after administration of a single dose of radiolabeled 14C-perampanel in healthy male subjects. (time frame: Approximately 14 Weeks). The study lists 7 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 3 Nov 2015; AzTrials last refreshed its copy on 2 Nov 2026.