Healthy SubjectsPhase 1NCT02279485
A Study to Demonstrate Bioequivalence Between a 12-mg Dose of an Oral Suspension Formulation of Perampanel and a 12-mg Tablet Formulation of Perampanel Under Fasted and Fed Conditions in Healthy Subjects
A Phase 1 study testing Perampanel in people with Healthy Subjects, run by Eisai Inc..
Trial summary
This is an open-label, 2-arm, single-dose, randomized crossover study. The study will enroll a total of 100 subjects (2 arms with 50 subjects in each arm). In Arm 1, bioequivalence between the oral suspension and tablet formulations of perampanel will be evaluated under fasted conditions; in Arm 2, bioequivalence… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- 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
- 100 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Jan 2015
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males or females, ages 18 to 55 years, inclusive, at the time of informed consent.
- Body mass index (BMI) of 18 to 32 kg/m2, inclusive at Screening.
- Females must not be lactating or pregnant at Screening or Baseline.
- Females of childbearing potential must not have had unprotected sexual intercourse within 30 days before study entry and must agree to use a highly effective method of contraception (eg, total abstinence, a doublebarrier method [such as condom plus diaphragm with spermicide], have a vasectomized partner with confirmed azoospermia, or an intrauterine device, contraceptive implant, or oral contraceptive that does not contain levogesterol) throughout the entire study period and for 30 days after study drug discontinuation. Females using hormonal contraceptives containing levogesterol must be on another form of contraception (such as double barrier method.) as well. If currently abstinent, the subject must agree to use a doublebarrier method as described above if she becomes sexually active during the study period or for 30 days after study drug discontinuation. Females who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least 4 weeks before dosing and must continue to use the same contraceptive during the study and for 30 days after study drug discontinuation. All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (i.e. bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing).
Who cannot join
- Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical attention within 4 weeks of dosing.
- Evidence of disease that may influence the outcome of the study within 4 weeks of dosing, eg, psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, cardiovascular system, or subjects who have a congenital abnormality in metabolism.
- Any history of gastrointestinal surgery that may affect PK profiles of perampanel, eg, hepatectomy, nephrotomy, cholecystectomy, digestive organ resection or any gastrointestinal procedure for the purpose of weight loss (including Lapband), which would slow gastric emptying.
- 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 or Baseline.
- Any laboratory abnormalities considered clinically significant by the investigator.
- A prolonged QT/QTc interval (QTc greater than 450 msec) as demonstrated upon repeat ECG at Screening or Baseline.
Show all 21Show fewer
- History of prolonged QT/QTc interval.
- History of risk factors for torsade de pointes (eg, heart failure, hypokalemia, family history of long QT syndrome).
- History of ischemic heart disease (eg, acute coronary syndromes, stable angina), syncope or cardiac arrhythmias.
- Siting heart rate less than 40 or greater than 100 beats/min at Screening or Baseline Period 1 and sitting systolic blood pressure greater than 140 mmHg or less than 90 mmHg or diastolic blood pressure greater than 90 mmHg or less than 60 mmHg at Screening or Baseline.
- Hemoglobin less than 11.5 g/dLfor females and less than 12.5 g/dL for males at screen and Baseline check-in Period 1.
- Subjects who experienced a weight loss or gain of greater than 10% between Screening and before dosing.
- Subjects who received blood products within 4 weeks, donated blood within 8 weeks, or donated plasma within 1 week of dosing.
- Hypersensitivity to the study drug or any of its excipients.
- Known history of food allergies or presently experiencing significant seasonal or perennial allergy at Screening.
- Known to be human immunodeficiency virus (HIV) positive at Screening.
- Active viral hepatitis (B or C) as demonstrated by positive serology at Screening.
- History of use of illegal (or legalized) recreational drugs in the past year.
- History of drug or alcohol dependency or abuse within approximately the last 2 years or who have a positive urine drug test or breath alcohol test at Screening or Baseline.
- Engagement in strenuous exercise within 2 weeks before dosing (eg, marathon runners, weight lifters).
- Currently enrolled in another clinical trial or used any investigational drug or device within 30 days preceding informed consent.
About this study
Official title: A Randomized, Open-Label, Crossover Study to Demonstrate Bioequivalence Between a 12-mg Dose of an Oral Suspension Formulation of Perampanel and a 12-mg Tablet Formulation of Perampanel Under Fasted and Fed Conditions in Healthy Subjects
This is an open-label, 2-arm, single-dose, randomized crossover study. The study will enroll a total of 100 subjects (2 arms with 50 subjects in each arm). In Arm 1, bioequivalence between the oral suspension and tablet formulations of perampanel will be evaluated under fasted conditions; in Arm 2, bioequivalence between the oral suspension and tablet formulations will be evaluated under fed conditions. In both study arms, subjects will be randomized on Study Day 1 for Treatment Period 1 to receive a single 12-mg dose for perampanel as either oral suspension or a tablet, and will then receive the alternative treatment on Study Day 43 of Treatment Period 2. Drug administration will be separated by a washout of at least 6 weeks between the two treatment periods.
- Conditions
- Healthy Subjects
- Being tested
- Perampanel
- Keywords
- Healthy Subjects, Bioequivalence, Fasted, Fed
- Medical subject headings
- Lecithin Cholesterol Acyltransferase Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PerampanelDrug
| Study group | Role | What they receive |
|---|---|---|
| Perampanel - Group 1 | Experimental | Treatment A: Single oral dose of a 12-mg perampanel tablet under fasted condition.
Treatment B: Single 12 mg dose of perampanel oral suspension under fasted condition.
Subjects will be randomized on Study Day 1 for Treatment Period 1 to Treatment A or Treatment B. On Study Day 43 the subject will then receive the alternate Treatment for Treatment Period 2. Receives: Drug: Perampanel |
| Perampanel - Group 2 | Experimental | Treatment C: Single oral dose of a 12-mg perampanel tablet co-administered with high fat meal.
Treatment D: Single 12 mg dose of perampanel oral suspension co-administered with high fat meal.
Subjects will be randomized on Study Day 1 for Treatment Period 1 to Treatment C or Treatment D. On Study Day 43 the subject will then receive the alternate Treatment for Treatment Period 2. Receives: Drug: Perampanel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of Perampanel: AUC(0-t)
Measured: Up to 504 hours postdose in each treatment period
Pharmacokinetics of Perampanel: AUC(0-inf)
Measured: Up to 504 hours postdose in each treatment period
Pharmacokinetics of Perampanel: Cmax
Measured: Up to 504 hours postdose in each treatment period
Secondary outcomes (5)
Pharmacokinetics of Perampanel: AUC(0-72h)
Measured: Up to 504 hours postdose in each treatment period
Pharmacokinetics of Perampanel: tmax
Measured: Up to 504 hours postdose in each treatment period
Pharmacokinetics of Perampanel: tlag
Measured: Up to 504 hours postdose in each treatment period
Pharmacokinetics of Perampanel: Lambda-z
Measured: Up to 504 hours postdose in each treatment period
Pharmacokinetics of Perampanel: t1/2
Measured: Up to 504 hours postdose in each treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2014
- Study completionJan 2015
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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 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
- NCT02279485
- Sponsor's protocol ID
- E2007-A001-048
- Status last verified
- Nov 2015
- First submitted
- 15 Oct 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
- A Randomized, Open-Label, Crossover Study to Demonstrate Bioequivalence Between a 12-mg Dose of an Oral Suspension Formulation of Perampanel and a 12-mg Tablet Formulation of Perampanel Under Fasted and Fed Conditions in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02279485
- Acronym / sponsor ID
- E2007-A001-048
- Conditions
- Healthy Subjects
- Keywords
- Healthy Subjects, Bioequivalence, Fasted, Fed
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 31 Oct 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, 2-arm, single-dose, randomized crossover study. The study will enroll a total of 100 subjects (2 arms with 50 subjects in each arm). In Arm 1, bioequivalence between the oral suspension and tablet formulations of perampanel will be evaluated under fasted conditions; in Arm 2, bioequivalence between the oral suspension and tablet formulations will be evaluated under fed conditions. In both study arms, subjects will be randomized on Study Day 1 for Treatment Period 1 to receive a single 12-mg dose for perampanel as either oral suspension or a tablet, and will then receive the alternative treatment on Study Day 43 of Treatment Period 2. Drug administration will be separated by a washout of at least 6 weeks between the two treatment periods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perampanel - Group 1 | Experimental | Drug: PerampanelTreatment A: Single oral dose of a 12-mg perampanel tablet under fasted condition. Treatment B: Single 12 mg dose of perampanel oral suspension under fasted condition. Subjects will be randomized on Study Day 1 for Treatment Period 1 to Treatment A or Treatment B. On Study Day 43 the subject will then receive the alternate Treatment for Treatment Period 2. |
| Perampanel - Group 2 | Experimental | Drug: PerampanelTreatment C: Single oral dose of a 12-mg perampanel tablet co-administered with high fat meal. Treatment D: Single 12 mg dose of perampanel oral suspension co-administered with high fat meal. Subjects will be randomized on Study Day 1 for Treatment Period 1 to Treatment C or Treatment D. On Study Day 43 the subject will then receive the alternate Treatment for Treatment Period 2. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy males or females, ages 18 to 55 years, inclusive, at the time of informed consent.
- Body mass index (BMI) of 18 to 32 kg/m2, inclusive at Screening.
- Females must not be lactating or pregnant at Screening or Baseline.
- Females of childbearing potential must not have had unprotected sexual intercourse within 30 days before study entry and must agree to use a highly effective method of contraception (eg, total abstinence, a doublebarrier method [such as condom plus diaphragm with spermicide], have a vasectomized partner with confirmed azoospermia, or an intrauterine device, contraceptive implant, or oral contraceptive that does not contain levogesterol) throughout the entire study period and for 30 days after study drug discontinuation. Females using hormonal contraceptives containing levogesterol must be on another form of contraception (such as double barrier method.) as well. If currently abstinent, the subject must agree to use a doublebarrier method as described above if she becomes sexually active during the study period or for 30 days after study drug discontinuation. Females who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least 4 weeks before dosing and must continue to use the same contraceptive during the study and for 30 days after study drug discontinuation. All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (i.e. bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing).
Key exclusion criteria (21 listed)
- Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical attention within 4 weeks of dosing.
- Evidence of disease that may influence the outcome of the study within 4 weeks of dosing, eg, psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, cardiovascular system, or subjects who have a congenital abnormality in metabolism.
- Any history of gastrointestinal surgery that may affect PK profiles of perampanel, eg, hepatectomy, nephrotomy, cholecystectomy, digestive organ resection or any gastrointestinal procedure for the purpose of weight loss (including Lapband), which would slow gastric emptying.
- 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 or Baseline.
- Any laboratory abnormalities considered clinically significant by the investigator.
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 |
|---|---|---|
| Perampanel | Drug | Perampanel - Group 1, Perampanel - Group 2 |
Primary outcome
Pharmacokinetics of Perampanel: AUC(0-t)
Time frame: Up to 504 hours postdose in each treatment period
Pharmacokinetics of Perampanel: AUC(0-inf)
Time frame: Up to 504 hours postdose in each treatment period
Pharmacokinetics of Perampanel: Cmax
Time frame: Up to 504 hours postdose in each treatment period
5 secondary outcomes
Pharmacokinetics of Perampanel: AUC(0-72h)
Time frame: Up to 504 hours postdose in each treatment period
Pharmacokinetics of Perampanel: tmax
Time frame: Up to 504 hours postdose in each treatment period
Pharmacokinetics of Perampanel: tlag
Time frame: Up to 504 hours postdose in each treatment period
Pharmacokinetics of Perampanel: Lambda-z
Time frame: Up to 504 hours postdose in each treatment period
Pharmacokinetics of Perampanel: t1/2
Time frame: Up to 504 hours postdose in each treatment period
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.
Related trials for Healthy Subjects
Not yet recruitingPhase 1
A Study of Phenytoin Mucoadhesive Film for Oral Ulcers in Healthy Volunteers
Oral Ulcer, Oral Mucositis
Not yet recruiting
SUVY VerSus SAccharose (SUVISA)
Healthy Volunteers, Erythritol
Not yet recruitingObservational study
Microneurographic Assessment of Peripheral Nerves in Healthy Volunteers and Individuals With Sensory Dysfunction Caused by Inherited Mutations in the PIEZO2 Gene
PIEZO2-Deficiency Syndrome
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples
RecruitingPhase 1
First-in-Human Evaluation of [11C]JMJ-129-d2 for PDE4D Imaging in Healthy Volunteers
Healthy
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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Perampanel in people with Healthy Subjects, run by Eisai Inc..
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 4 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 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
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 of Perampanel: AUC(0-t) (time frame: Up to 504 hours postdose in each treatment period). The study lists 3 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.