Demonstrate Bioequivalence Between 3 x 2-mg Tablets of Perampanel and a Single 6-mg Tablet of Perampanel in Healthy Subjects
Study Details
Study Description
Brief Summary
The purpose of this study is to determine that three 2-mg tablets of perampanel are bioequivalent to one 6-mg tablet of perampanel.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Active Comparator: 3 x 2-mg perampanel
|
Drug: perampanel
3 x 2 mg perampanel once per day
|
Active Comparator: 6mg perampanel
|
Drug: perampanel
6 mg perampanel once per day
|
Outcome Measures
Primary Outcome Measures
- Cmax of 6 x 2-mg perampanel tablets (reference) compared to that of the 12-mg perampanel tablet (test), [8 days]
- AUC(0-t) of 6 x 2-mg perampanel tablets (reference) compared to that of the 12-mg perampanel tablet (test) [8 days]
- AUC(0-inf) of 6 x 2-mg perampanel tablets (ref) compared to that of the 12-mg perampanel tablet (test) [8 days]
Secondary Outcome Measures
- The incidence of AEs [8 days]
Eligibility Criteria
Criteria
Inclusion:
-
Healthy male or female subjects, age 18 to 55 years old, inclusive, at Screening
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Body mass index (BMI) of 18 to 32 kg/m^2, inclusive, at Screening
Exclusion:
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Subjects who are taking any prescribed or over-the-counter drug or herbal remedies in the 2 weeks prior to Screening (unless the OTC drug has a long halflife [i.e., 5 x 1/2 greater than 2 weeks]) with the exception of acetaminophen (up to 4 g/day), which is allowed up to 12 hours prior to dosing
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Subjects who have taken St John's Wort or other dietary aids known to induce CYP3A4 within 4 weeks prior to dosing
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Subjects who have taken any inhibitor of CYP450 within 2 weeks prior to the first dosing (e.g., grapefruit, grapefruit juice, grapefruit-containing beverages, apple or Seville orange products)
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Subjects who have received any experimental drug within the 12 weeks leading up to the start of study drug treatment or who are currently enrolled in another clinical trial
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Subjects with a known or suspected history of alcohol abuse within the 6 months prior to Screening or who have a positive urine drug test or breath alcohol test at Screening or Baseline, or who are unwilling to abstain from consumption of alcohol throughout the periods of in-patient confinement
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Subjects who consume more than 5 caffeinated beverages per day (e.g., 5 cups of tea, coffee or cans of cola) or who are unwilling to abstain from consumption of caffeine-containing food and beverages throughout the periods of in-patient confinement
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Subjects who smoke more than 5 cigarettes (or equivalent amount of tobacco) per day or who are unwilling to abstain from the use of nicotine-containing products throughout the period of in-patient confinement
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Subjects who have a history of drug abuse or dependence or have a positive result from a urine drug screening test
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Women of child-bearing potential who do not agree to use 2 methods of adequate contraception (e.g., intrauterine device, barrier methods with spermicide) throughout the study and for 30 days after study drug administration
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Fargo | North Dakota | United States |
Sponsors and Collaborators
- Eisai Inc.
Investigators
- Principal Investigator: Robert Cooper, Eisai Medical Services
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- E2007-A001-039