HealthyPhase 1NCT02020486
A Multiple Dose Pharmacokinetic Study of Perampanel in Korean Healthy Subjects
A Phase 1 study testing Perampanel in people with Healthy, run by Eisai Co., Ltd. at 1 site in South Korea.
Trial summary
This study will consist of 2 phases: Pretreatment Phase and Treatment Phase. The Pretreatment Phase will have 2 time points: Screening and Baseline. Subjects will be admitted to the clinical study ward the day before starting the study drug administration (Day -1) for PK and safety assessments during Treatment Phase… Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Perampanel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 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 19 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects who meet all of the following criteria will be included in the study:
- Korean healthy adult male volunteers
- Non-smoking, male subjects aged at least 19 years and no more than 55 years old at the time of informed consent
- Body Mass Index (BMI) of greater than 18 and less than or equal to 30 kg/m2 at Screening. Note: BMI (kg/m2) = body weight (kg)/[height (m) x height (m)]
- Male subjects must have had a successful vasectomy (confirmed azoospermia) or they and their female partners are not of childbearing potential or practicing highly effective contraception throughout the study period and for 30 days after study drug discontinuation. No sperm donation is 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 participation in the study:
- Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing
- Evidence of disease that may influence the outcome of the study within 4 weeks prior to dosing; e.g., psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system, or subjects who have a congenital abnormality in metabolism
- Any history of gastrointestinal surgery that may affect PK profiles of perampanel, e.g., hepatectomy, nephrotomy, digestive organ resection at Screening and Baseline
- Evidence of clinically significant organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations. Subjects whose liver enzyme values are outside of the acceptable normal limits will be excluded
- A prolonged QT/QTc interval (QTc greater than 450 ms) demonstrated on ECG at Screening or Baseline
Show all 21Show fewer
- Any suicidal ideation with intent with or without a plan at Screening or within 6 months of Screening
- Any lifetime suicidal behavior
- Known history of clinically significant drug allergy at Screening and Baseline
- Known history of food allergies or presently experiencing significant seasonal or perennial allergy at Screening and Baseline
- Known to be human immunodeficiency virus (HIV) positive at Screening
- Active viral hepatitis (A, B or C) as demonstrated by positive serology at Screening
- History of drug or alcohol dependency or abuse within the 2 years prior to Screening, or those who have a positive urine drug test or breath (or urine) alcohol test at Screening or Baseline
- Intake of caffeinated beverages or food within 72 hours prior to dosing
- Intake of nutritional supplements, juice, and herbal preparations or other foods or beverages that may affect CYP (e.g., alcohol, grapefruit, grapefruit juice, grapefruit-containing beverages, apple or orange juice, vegetables from the mustard green family [e.g., kale, broccoli, watercress, collard greens, kohlrabi, brussel sprouts, mustard], and charbroiled meats) within 1 week prior to dosing
- Intake of herbal preparations containing St. John's Wort within 4 weeks prior to dosing
- Use of prescription drugs within 4 weeks prior to dosing
- Intake of over-the-counter (OTC) medications within 2 weeks prior to dosing
- Currently enrolled in another clinical trial or used any investigational drug or device within 30 days or 5x the half-life, whichever is longer preceding informed consent
- Receipt of blood products within 4 weeks, or donation of blood within 8 weeks, or donation of plasma within one week of dosing
- Engagement in strenuous exercise within 2 weeks prior to check-in (e.g., marathon runners, weight lifters, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
This study will consist of 2 phases: Pretreatment Phase and Treatment Phase. The Pretreatment Phase will have 2 time points: Screening and Baseline. Subjects will be admitted to the clinical study ward the day before starting the study drug administration (Day -1) for PK and safety assessments during Treatment Phase, and discharged at Day 33 (group A) and Day 47 (group B). Post-test will be done at Day 37 (+/-1), Day 42 (+3) (group A) and Day 51 (+/-1), Day 56 (+3) (group B). Study medication will be administered with 240 mL of room temperature water
- Conditions
- Healthy
- Being tested
- Perampanel
- Keywords
- Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PerampanelDrug
2 mg up to 4 mg
PerampanelDrug
2 mg up to 6 mg
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Experimental Receives: Drug: Perampanel |
| Group B | Experimental | Days 1-14: Multiple oral dose of 2 mg perampanel (one 2 mg tablet) Days 15-28: Multiple oral dose of 4 mg perampanel (two 2 mg tablets) Days 29-42: Multiple oral dose of 6 mg perampanel (three 2 mg tablets) Receives: Drug: Perampanel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK) of perampanel in Korean healthy male subjects
PK analysis will be performed on PK Analysis Set using plasma concentrations of perampanel. Plasma concentrations will be tabulated by nominal sampling time and summarized using summary statistics.
Measured: Approximately 56 days
Secondary outcomes (1)
Safety and tolerability of perampanel
Safety will be assessed by monitoring and recording all adverse events (AEs) and serious adverse events (SAEs), regular monitoring of hematology, blood chemistry and urine values, regular measurement of vital signs, weight, physical examinations and electrocardiograms (ECGs).
Measured: Approximately 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02020486
- Sponsor's protocol ID
- E2007-K082-047
- Status last verified
- Sep 2014
- First submitted
- 4 Dec 2013
- Last updated
- 3 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Dose Pharmacokinetic Study of Perampanel in Korean Healthy Subjects
- ClinicalTrials.gov ID
- NCT02020486
- Acronym / sponsor ID
- E2007-K082-047
- Conditions
- Healthy
- Keywords
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 25 Dec 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 will consist of 2 phases: Pretreatment Phase and Treatment Phase. The Pretreatment Phase will have 2 time points: Screening and Baseline. Subjects will be admitted to the clinical study ward the day before starting the study drug administration (Day -1) for PK and safety assessments during Treatment Phase, and discharged at Day 33 (group A) and Day 47 (group B). Post-test will be done at Day 37 (+/-1), Day 42 (+3) (group A) and Day 51 (+/-1), Day 56 (+3) (group B). Study medication will be administered with 240 mL of room temperature water
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: PerampanelExperimental |
| Group B | Experimental | Drug: PerampanelDays 1-14: Multiple oral dose of 2 mg perampanel (one 2 mg tablet) Days 15-28: Multiple oral dose of 4 mg perampanel (two 2 mg tablets) Days 29-42: Multiple oral dose of 6 mg perampanel (three 2 mg tablets) |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Korean healthy adult male volunteers
- Non-smoking, male subjects aged at least 19 years and no more than 55 years old at the time of informed consent
- Body Mass Index (BMI) of greater than 18 and less than or equal to 30 kg/m2 at Screening. Note: BMI (kg/m2) = body weight (kg)/[height (m) x height (m)]
- Male subjects must have had a successful vasectomy (confirmed azoospermia) or they and their female partners are not of childbearing potential or practicing highly effective contraception throughout the study period and for 30 days after study drug discontinuation. No sperm donation is allowed during the study period and for 30 days after study drug discontinuation
- Provide written informed consent
Key exclusion criteria (21 listed)
- Subjects who meet any of the following criteria will be excluded from participation in the study:
- Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing
- Evidence of disease that may influence the outcome of the study within 4 weeks prior to dosing; e.g., psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system, or subjects who have a congenital abnormality in metabolism
- Any history of gastrointestinal surgery that may affect PK profiles of perampanel, e.g., hepatectomy, nephrotomy, digestive organ resection at Screening and Baseline
- Evidence of clinically significant organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations. Subjects whose liver enzyme values are outside of the acceptable normal limits will be excluded
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 |
|---|---|---|
| Perampanel2 mg up to 4 mg | Drug | Group A |
| Perampanel2 mg up to 6 mg | Drug | Group B |
Primary outcome
Pharmacokinetics (PK) of perampanel in Korean healthy male subjects
Time frame: Approximately 56 days
PK analysis will be performed on PK Analysis Set using plasma concentrations of perampanel. Plasma concentrations will be tabulated by nominal sampling time and summarized using summary statistics.
1 secondary outcome
Safety and tolerability of perampanel
Time frame: Approximately 56 days
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 Mar 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 Perampanel in people with Healthy, run by Eisai Co., Ltd. at 1 site in South Korea.
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 7 inclusion and 21 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 Mar 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 South Korea. 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 (PK) of perampanel in Korean healthy male subjects (time frame: Approximately 56 days). 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 Mar 2015; AzTrials last refreshed its copy on 7 Nov 2026.