Healthy ParticipantsPhase 1NCT03399734
Bioequivalence Study Between a 4-mg Dose of Fine Granules of Perampanel and a 4-mg Tablet of Perampanel in Healthy Japanese Subjects
A Phase 1 study testing Perampanel in people with Healthy Participants, run by Eisai Co., Ltd. at 1 site in Japan.
Trial summary
This study will be conducted to demonstrate the bioequivalence between a single 4 milligram (mg) dose of fine granules of perampanel and a single 4 mg tablet of perampanel. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- 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
- 24 participants
- Where
- 1 siteJapan
- Study dates
- 18 Dec 2017to 9 Mar 2018
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must meet all of the following criteria to be included in this study:
- Non-smoking, male or female age ≥20 years and ≤45 years old at the time of obtaining written informed consent. To be considered non-smokers, participants must have discontinued smoking from Screening before first dosing.
- Body Mass Index ≥18.5 and <25.0 kilograms per meters squared at Screening
Who cannot join
- Participants who meet any of the following criteria will be excluded from this study:
- Females who are breastfeeding or pregnant at Screening or Baseline
- Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks before first dosing
- Evidence of disease that may influence the outcome of the study within 4 weeks before first dosing
- Any history of gastrointestinal surgery that may affect pharmacokinetic profiles of perampanel at Screening
- Any clinically abnormal symptom or organ impairment found by medical history at Screening, and physical examinations, vital signs, electrocardiogram (ECG) finding, or laboratory test results that require medical treatment at Screening
- A prolonged QT/QT corrected interval (QT interval, Fridericia correction >450 milliseconds) as demonstrated by a repeated ECG at Screening or Baseline
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-Label, Crossover Study to Demonstrate Bioequivalence Between a 4-mg Dose of Fine Granules of Perampanel and a 4-mg Tablet of Perampanel in Healthy Japanese Subjects
This study will be conducted to demonstrate the bioequivalence between a single 4 milligram (mg) dose of fine granules of perampanel and a single 4 mg tablet of perampanel.
- Conditions
- Healthy Participants
- Being tested
- Perampanel
- Keywords
- Perampanel, Bioequivalence, fine granules, E2007, Japanese
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PerampanelDrug
Also called E2007
Single oral dose of 1 x 4-mg perampanel tablet
PerampanelDrug
Also called E2007
Single 4-mg dose of perampanel fine granules
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | 4 milligrams (mg) perampanel tablet Receives: Drug: Perampanel |
| Treatment B | Experimental | 4 mg perampanel fine granules Receives: Drug: Perampanel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed concentration (Cmax)
Measured: 0-168 hours postdose of Treatment Period 1 and Treatment Period 2
Area under the concentration-time curve from zero time to 168 hours (AUC[0-168h])
Measured: 0-168 hours postdose of Treatment Period 1 and Treatment Period 2
Secondary outcomes (8)
Time at which the highest drug concentration occurs (tmax)
Measured: 0-168 hours postdose of Treatment Period 1 and Treatment Period 2
Lag time (tlag)
tlag is the time delay between drug administration and the onset of drug absorption.
Measured: 0-168 hours postdose of Treatment Period 1 and Treatment Period 2
Area under the concentration-time curve from zero time to 72 hours (AUC[0-72h])
Measured: 0-72 hours postdose of Treatment Period 1 and Treatment Period 2
Area under the concentration-time curve from zero time to time of the last quantifiable concentration (AUC[0-t])
Measured: 0-168 hours postdose of Treatment Period 1 and Treatment Period 2
Area under the concentration-time curve from zero time extrapolated to infinite time (AUC[0-inf])
Measured: 0-168 hours postdose of Treatment Period 1 and Treatment Period 2
Terminal phase rate constant (λz)
Measured: 0-168 hours postdose of Treatment Period 1 and Treatment Period 2
Terminal elimination phase half-life (t1/2)
Measured: 0-168 hours postdose of Treatment Period 1 and Treatment Period 2
Mean residence time (MRT)
Measured: 0-168 hours postdose of Treatment Period 1 and Treatment Period 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2018
- Study start18 Dec 2017
- Primary completion9 Mar 2018
- Study completion9 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT03399734
- Sponsor's protocol ID
- E2007-J081-053
- Status last verified
- Jan 2018
- First submitted
- 8 Jan 2018
- Last updated
- 29 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Crossover Study to Demonstrate Bioequivalence Between a 4-mg Dose of Fine Granules of Perampanel and a 4-mg Tablet of Perampanel in Healthy Japanese Subjects
- ClinicalTrials.gov ID
- NCT03399734
- Acronym / sponsor ID
- E2007-J081-053
- Conditions
- Healthy Participants
- Keywords
- Perampanel, Bioequivalence, fine granules, E2007, Japanese
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Dec 2017 (actual)
- Primary completion
- 9 Mar 2018 (actual)
- Study completion
- 9 Mar 2018 (actual)
- First posted
- 16 Jan 2018 (actual)
- 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 be conducted to demonstrate the bioequivalence between a single 4 milligram (mg) dose of fine granules of perampanel and a single 4 mg tablet of perampanel.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: Perampanel4 milligrams (mg) perampanel tablet |
| Treatment B | Experimental | Drug: Perampanel4 mg perampanel fine granules |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Non-smoking, male or female age ≥20 years and ≤45 years old at the time of obtaining written informed consent. To be considered non-smokers, participants must have discontinued smoking from Screening before first dosing.
- Body Mass Index ≥18.5 and <25.0 kilograms per meters squared at Screening
Key exclusion criteria (7 listed)
- Females who are breastfeeding or pregnant at Screening or Baseline
- Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks before first dosing
- Evidence of disease that may influence the outcome of the study within 4 weeks before first dosing
- Any history of gastrointestinal surgery that may affect pharmacokinetic profiles of perampanel at Screening
- Any clinically abnormal symptom or organ impairment found by medical history at Screening, and physical examinations, vital signs, electrocardiogram (ECG) finding, or laboratory test results that require medical treatment at Screening
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 |
|---|---|---|
| PerampanelAlso: E2007Single oral dose of 1 x 4-mg perampanel tablet | Drug | Treatment A |
| PerampanelAlso: E2007Single 4-mg dose of perampanel fine granules | Drug | Treatment B |
Primary outcome
Maximum observed concentration (Cmax)
Time frame: 0-168 hours postdose of Treatment Period 1 and Treatment Period 2
Area under the concentration-time curve from zero time to 168 hours (AUC[0-168h])
Time frame: 0-168 hours postdose of Treatment Period 1 and Treatment Period 2
8 secondary outcomes
Time at which the highest drug concentration occurs (tmax)
Time frame: 0-168 hours postdose of Treatment Period 1 and Treatment Period 2
Lag time (tlag)
Time frame: 0-168 hours postdose of Treatment Period 1 and Treatment Period 2
Area under the concentration-time curve from zero time to 72 hours (AUC[0-72h])
Time frame: 0-72 hours postdose of Treatment Period 1 and Treatment Period 2
Area under the concentration-time curve from zero time to time of the last quantifiable concentration (AUC[0-t])
Time frame: 0-168 hours postdose of Treatment Period 1 and Treatment Period 2
Area under the concentration-time curve from zero time extrapolated to infinite time (AUC[0-inf])
Time frame: 0-168 hours postdose of Treatment Period 1 and Treatment Period 2
Terminal phase rate constant (λz)
Time frame: 0-168 hours postdose of Treatment Period 1 and Treatment Period 2
Terminal elimination phase half-life (t1/2)
Time frame: 0-168 hours postdose of Treatment Period 1 and Treatment Period 2
Mean residence time (MRT)
Time frame: 0-168 hours postdose of Treatment Period 1 and Treatment Period 2
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 29 Oct 2018.
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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 Participants, run by Eisai Co., Ltd. at 1 site in Japan.
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 3 inclusion and 7 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 29 Oct 2018. 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 Japan. 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?
Maximum observed concentration (Cmax) (time frame: 0-168 hours postdose of Treatment Period 1 and Treatment Period 2). 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 29 Oct 2018.