Clinical trial NCT03399734: Bioequivalence Study Between a 4-mg Dose of Fine Granules of Perampanel and a 4-mg Tablet of Perampanel in Healthy Japanese Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: Perampanel
Bioequivalence
fine granules
E2007
Japanese
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2018-01-16
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: Inclusion Criteria

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

Exclusion Criteria

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

Primary outcomes:
measure: Maximum observed concentration (Cmax)
timeFrame: 0-168 hours postdose of Treatment Period 1 and Treatment Period 2
measure: Area under the concentration-time curve from zero time to 168 hours (AUC[0-168h])
timeFrame: 0-168 hours postdose of Treatment Period 1 and Treatment Period 2
Secondary outcomes:
measure: Time at which the highest drug concentration occurs (tmax)
timeFrame: 0-168 hours postdose of Treatment Period 1 and Treatment Period 2
measure: Lag time (tlag)
timeFrame: 0-168 hours postdose of Treatment Period 1 and Treatment Period 2
measure: Area under the concentration-time curve from zero time to 72 hours (AUC[0-72h])
timeFrame: 0-72 hours postdose of Treatment Period 1 and Treatment Period 2
measure: Area under the concentration-time curve from zero time to time of the last quantifiable concentration (AUC[0-t])
timeFrame: 0-168 hours postdose of Treatment Period 1 and Treatment Period 2
measure: Area under the concentration-time curve from zero time extrapolated to infinite time (AUC[0-inf])
timeFrame: 0-168 hours postdose of Treatment Period 1 and Treatment Period 2
measure: Terminal phase rate constant (λz)
timeFrame: 0-168 hours postdose of Treatment Period 1 and Treatment Period 2
measure: Terminal elimination phase half-life (t1/2)
timeFrame: 0-168 hours postdose of Treatment Period 1 and Treatment Period 2
measure: Mean residence time (MRT)
timeFrame: 0-168 hours postdose of Treatment Period 1 and Treatment Period 2
Other outcomes:
Locations:
city: Toshima-ku
country: Japan
facility: Eisai Trial Site
state: Tokyo
Study officials:
References: