Status:
COMPLETED
Pharmacokinetic Study of Perampanel in Chinese Healthy Subjects
Lead Sponsor:
Eisai Co., Ltd.
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
This study will be conducted to evaluate the pharmacokinetics of perampanel following single and multiple oral doses in Chinese healthy male and female participants.
Eligibility Criteria
Inclusion
- Participants must meet all of the following criteria to be included in this study:
- Chinese healthy adult volunteers (males and females)
- Non-smoking, male or female age ≥18 years and ≤45 years old at the time of obtaining written consent. To be considered non-smokers, participants must have discontinued smoking from screening before first dosing.
- Participants with a Body Mass Index ≥18.5 and \<24.5 kilograms per meters squared at screening
- Participants who undergo screening within 3 weeks before study treatment and are confirmed to be eligible by the investigator
Exclusion
- Participants who meet any of the following criteria will be excluded from this study:
- Participants who weigh less than 50 kilograms
- Females who are breastfeeding or pregnant at Screening or Baseline
- Females of childbearing potential
- 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/corrected QT (QTc) interval (QTc interval for heart rate using Fredericia's formula \>450 milliseconds) as demonstrated by a repeated ECG at Screening or Baseline
Key Trial Info
Start Date :
March 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 25 2018
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT03424564
Start Date
March 20 2018
End Date
May 25 2018
Last Update
August 28 2018
Active Locations (1)
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1
Eisai Trial Site
Beijing, Beijing Municipality, China