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Healthy ParticipantsPhase 1NCT03376997

Study to Evaluate Bioavailability of a Single 12 mg Dose of Perampanel for Three Intravenous Infusion Durations Relative to a Single 12 mg Perampanel Oral Tablet in Healthy Subjects

A Phase 1 study testing Perampanel in people with Healthy Participants, run by Eisai Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will be conducted to evaluate the bioavailability of a single 12 milligram (mg) dose of perampanel intravenous infusions of different durations relative to a single 12 mg dose of perampanel oral tablet in healthy participants. Read more about this study

Who is it for?
Ages 20 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Participants
What is being tested?
Perampanel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteUnited States
Study dates
8 Nov 2017to 16 Feb 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 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Non-smoking, male or female, between 20 and 55 years of age (inclusive) at the time of informed consent
  • Body mass index (BMI) of 18 to 32 kilograms per meters squared (kg/m^2) (inclusive) at Screening
  • For Japanese participants:
  • Born in Japan to Japanese parents and grandparents of Japanese descent; ii. Have been living outside Japan for less than 5 years; and iii. Lifestyle, including diet, has not changed significantly since leaving Japan
  • Provide written informed consent
  • Willing and able to comply with all aspects of the protocol

Who cannot join

  • Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing
  • Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin [ß-hCG]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
  • Females of childbearing potential who:
  • Within 28 days before study entry, did not use a highly effective method of contraception, which includes any of the following:
  • total abstinence (if it is their preferred and usual lifestyle);
  • an intrauterine device or intrauterine hormone-releasing system (IUS);
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  • a contraceptive implant;
  • an oral contraceptive (with additional barrier method). Participant must be on a stable dose of the same oral contraceptive product for at least 28 days before dosing and throughout the study and for 28 days after study drug discontinuation; or
  • have a vasectomized partner with confirmed azoospermia ii. Do not agree to use a highly effective method of contraception (as described above) throughout the entire study period and for 28 days after study drug discontinuation NOTE: 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 (ie, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before 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 participants who have a congenital abnormality in metabolism
  • Any history of gastrointestinal surgery that may affect pharmacokinetics (PK) profiles of perampanel, eg, hepatectomy, nephrectomy, 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. A single repeat test for an abnormal vital sign and/or laboratory value is permitted, at the discretion of the Investigator.
  • A prolonged QT/QTc interval (QTc >450 milliseconds [msec]) as demonstrated upon repeat ECG at Screening or Baseline
  • Heart rate <50 or >100 beats per minute at Screening or Baseline
  • History of ischemic heart disease (eg, acute coronary syndromes, stable angina), syncope or cardiac arrhythmias
  • Systolic blood pressure >140 millimeters of mercury (mmHg) or <90 mmHg or diastolic blood pressure >90 mmHg or <60 mmHg at Screening or Baseline
  • Hemoglobin <12.5 grams per deciliter (g/dL) or hematocrit ≤38% for males and postmenopausal females and hemoglobin <10 g/dL or hematocrit ≤33% for pre-menopausal females at Screening
  • Participants who experienced a weight loss or gain of >10% between Screening and the first clinic check-in (Day -1)
  • Participants 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 severe or clinically significant 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 drug or alcohol dependency or abuse within approximately the last 2 years or who have a positive urine drug, cotinine, or 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
  • Restrictions on prior and concomitant medications, food and beverages:
  • Prescription drugs are prohibited within 4 weeks of dosing and over-the-counter (OTC) drugs within 2 weeks before dosing or throughout the Treatment Phase ii. Smoking or use of tobacco or nicotine-containing products is prohibited within 4 weeks before dosing and throughout the Treatment Phase iii. Intake of caffeinated beverages or food is prohibited within 72 hours before dosing and until 72 hours postdose iv. Intake of nutritional supplements, juice, and herbal preparations or other foods or beverages that may affect Cytochrome P450 (CYP) 3A4 enzyme or transporters (eg, alcohol, grapefruit, grapefruit juice, grapefruit-containing beverages, apple or orange juice, vegetables from the mustard green family [eg, kale, broccoli, watercress, collard greens, kohlrabi, brussels sprouts, mustard] and charbroiled meats) is prohibited within 2 weeks before dosing and throughout the Treatment Phase v. Intake of herbal preparations containing St. John's Wort is prohibited within 4 weeks before dosing and throughout the Treatment Phase

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Anaheim Clinical Trials

    Anaheim, California, 92801

Other trials in United States

About this study

Official title: An Open-Label, Randomized, Crossover Study to Evaluate Bioavailability of a Single 12 mg Dose of Perampanel for Three Intravenous Infusion Durations Relative to a Single 12 mg Perampanel Oral Tablet in Healthy Subjects

This study will be conducted to evaluate the bioavailability of a single 12 milligram (mg) dose of perampanel intravenous infusions of different durations relative to a single 12 mg dose of perampanel oral tablet in healthy participants.

Being tested
Perampanel
Keywords
Bioavailability, Perampanel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PerampanelDrug

    Also called E2007

    IV infusion

  • PerampanelDrug

    Also called E2007

    Oral tablet

Study groups in NCT03376997
Study groupRoleWhat they receive
Perampanel: 30-minute IV infusion and 12 mg oral tabletExperimentalParticipants will be randomized on Day 1 of Treatment Period 1 to receive either a single 12 milligram (mg) dose of perampanel intravenous (IV) infusion (30-minute duration) or a single 12 mg oral tablet after an overnight fast. Participants will then receive the alternative treatment on Day 43 of Treatment Period 2. Drug administration will be separated by a washout of at least 6 weeks between the 2 treatment periods.
Receives: Drug: Perampanel
Perampanel: 60-minute IV infusion and 12 mg oral tabletExperimentalParticipants will be randomized on Day 1 of Treatment Period 1 to receive either a single 12 mg dose of perampanel IV infusion (60-minute duration) or a single 12 mg oral tablet after an overnight fast. Participants will then receive the alternative treatment on Day 43 of Treatment Period 2. Drug administration will be separated by a washout of at least 6 weeks between the 2 treatment periods.
Receives: Drug: Perampanel
Perampanel: 90-minute IV infusion and 12 mg oral tabletExperimentalParticipants will be randomized on Day 1 of Treatment Period 1 to receive either a single 12 mg dose of perampanel IV infusion (90-minute duration) or a single 12 mg oral tablet after an overnight fast. Participants will then receive the alternative treatment on Day 43 of Treatment Period 2. Drug administration will be separated by a washout of at least 6 weeks between the 2 treatment periods.
Receives: Drug: Perampanel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean maximum observed concentration (Cmax) postdose of perampanel

    Cmax is the maximum plasma concentration of a drug after administration. Dosing will occur on Day 1 of Treatment Period 1 and Day 43 of Treatment Period 2.

    Measured: predose; 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, and 12 (Day [D]1 and D43); 24 and 36 (D2 and D44); 48 (D3 and D45); 72 (D4 and D46); 120 (D6 and D48); 168 (D8 and D50); 336 (D15 and D57); and 504 (D22 and D64) hours after dosing start

  2. Mean value for area under the concentration versus time curve from time 0 to time of last measurable concentration (AUC[0-t]) postdose of perampanel

    AUC is a measure of actual body exposure to drug after administration of the drug. Dosing will occur on Day 1 of Treatment Period 1 and Day 43 of Treatment Period 2.

    Measured: predose; 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, and 12 (D1 and D43); 24 and 36 (D2 and D44); 48 (D3 and D45); 72 (D4 and D46); 120 (D6 and D48); 168 (D8 and D50); 336 (D15 and D57); and 504 (D22 and D64) hours after dosing start

  3. Mean value for AUC versus time curve from time 0 to infinity (AUC[0-inf]) postdose of perampanel

    AUC is a measure of actual body exposure to drug after administration of the drug. Dosing will occur on Day 1 of Treatment Period 1 and Day 43 of Treatment Period 2.

    Measured: predose; 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, and 12 (D1 and D43); 24 and 36 (D2 and D44); 48 (D3 and D45); 72 (D4 and D46); 120 (D6 and D48); 168 (D8 and D50); 336 (D15 and D57); and 504 (D22 and D64) hours after dosing start

Secondary outcomes (11)

  1. Mean value for AUC versus time curve from time 0 to 72 hours (AUC[0-72h]) postdose of perampanel

    AUC is a measure of actual body exposure to drug after administration of the drug. Dosing will occur on Day 1 of Treatment Period 1 and Day 43 of Treatment Period 2.

    Measured: predose; 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, and 12 (D1 and D43); 24 and 36 (D2 and D44); 48 (D3 and D45); 72 (D4 and D46); 120 (D6 and D48); 168 (D8 and D50); 336 (D15 and D57); and 504 (D22 and D64) hours after dosing start

  2. Mean time to reach maximum concentration (tmax) postdose of perampanel

    tmax is the time to reach maximum concentration following drug administration. Dosing will occur on Day 1 of Treatment Period 1 and Day 43 of Treatment Period 2.

    Measured: predose; 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, and 12 (D1 and D43); 24 and 36 (D2 and D44); 48 (D3 and D45); 72 (D4 and D46); 120 (D6 and D48); 168 (D8 and D50); 336 (D15 and D57); and 504 (D22 and D64) hours after dosing start

  3. Mean terminal phase half-life (t1/2) postdose of perampanel

    t1/2 is the time required for the concentration of the drug to reach half of its original value. Dosing will occur on Day 1 of Treatment Period 1 and Day 43 of Treatment Period 2.

    Measured: predose; 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, and 12 (D1 and D43); 24 and 36 (D2 and D44); 48 (D3 and D45); 72 (D4 and D46); 120 (D6 and D48); 168 (D8 and D50); 336 (D15 and D57); and 504 (D22 and D64) hours after dosing start

  4. Mean total clearance (CL) post intravenous (IV) infusion of perampanel

    CL is the volume of plasma cleared of drug per unit time. Dosing will occur on Day 1 of Treatment Period 1 and Day 43 of Treatment Period 2.

    Measured: predose; 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, and 12 (D1 and D43); 24 and 36 (D2 and D44); 48 (D3 and D45); 72 (D4 and D46); 120 (D6 and D48); 168 (D8 and D50); 336 (D15 and D57); and 504 (D22 and D64) hours after dosing start

  5. Mean volume of distribution (Vd) post IV infusion of perampanel

    Vd is the apparent volume in which a drug is distributed. Dosing will occur on Day 1 of Treatment Period 1 and Day 43 of Treatment Period 2.

    Measured: predose; 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, and 12 (D1 and D43); 24 and 36 (D2 and D44); 48 (D3 and D45); 72 (D4 and D46); 120 (D6 and D48); 168 (D8 and D50); 336 (D15 and D57); and 504 (D22 and D64) hours after dosing start

  6. Number of participants with any treatment-emergent (TE) serious adverse event (SAE)

    An SAE is any untoward medical occurrence that at any dose: results in death; is life threatening (an adverse event [AE] is considered life-threatening if, in the view of either the Investigator or Sponsor, its occurrence places the participant at immediate risk of death. It does not include an AE that, had it occurred in a more severe form, might have caused death.); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect. A TEAE is defined as an AE that emerges during treatment, having been absent at pretreatment (baseline) or (1) reemerges during treatment, having been present at pretreatment (baseline) but stopped before treatment, or (2) worsens in severity during treatment relative to the pretreatment state, when the AE is continuous.

    Measured: Up to approximately 16 weeks

  7. Number of participants with any non-serious TEAE

    An AE is any untoward medical occurrence and does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product (IP), whether or not related to the IP. AEs include pre-existing conditions that worsen. A TEAE is defined as an AE that emerges during treatment, having been absent at pretreatment (baseline) or (1) reemerges during treatment, having been present at pretreatment (baseline) but stopped before treatment, or (2) worsens in severity during treatment relative to the pretreatment state, when the AE is continuous.

    Measured: Up to approximately 16 weeks

  8. Number of participants with an abnormal, clinically significant laboratory parameter value

    Clinical significance will be determined by the Investigator.

    Measured: Up to approximately 16 weeks

  9. Number of participants requiring concomitant medication

    Concomitant medications are medications that started after the date of the first dose of perampanel until the end of the study.

    Measured: Up to approximately 16 weeks

  10. Number of participants with an abnormal, clinically significant vital sign value

    Clinical significance will be determined by the Investigator.

    Measured: Up to approximately 16 weeks

  11. Number of participants with an abnormal, clinically significant physical examination finding

    Clinical significance will be determined by the Investigator.

    Measured: Up to approximately 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2017
  2. Study start8 Nov 2017
  3. Primary completion16 Feb 2018
  4. Study completion16 Feb 2018

Resources

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
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03376997
Sponsor's protocol ID
E2007-A001-050
Status last verified
Dec 2017
First submitted
13 Dec 2017
Last updated
7 Sep 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Hussein Z, Majid O, Boyd P, Aluri J, Ngo LY, Reyderman L. Intravenous Perampanel as an Interchangeable Alternative to Oral Perampanel: A Randomized, Crossover, Phase I Pharmacokinetic and Safety Study. Clin Pharmacol Drug Dev. 2022 Jul;11(7):878-888. doi: 10.1002/cpdd.1107. Epub 2022 May 20.

    PubMed 35596529

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Perampanel in people with Healthy Participants, 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 6 inclusion and 28 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 7 Sep 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 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?

Mean maximum observed concentration (Cmax) postdose of perampanel (time frame: predose; 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, and 12 (Day [D]1 and D43); 24 and 36 (D2 and D44); 48 (D3 and D45); 72 (D4 and D46); 120 (D6 and D48); 168 (D8 and D50); 336 (D15 and D57); and 504 (D22 and D64) hours after dosing start). 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?

On the ClinicalTrials.gov record for NCT03376997, which also lists 1 linked publication.

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 7 Sep 2018.

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