A Study to Determine the Effect of a High-Fat Meal on the Rate and Extent of E2006 Absorption in Healthy Subjects
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 4/21/2016 |
Start Date: | February 2014 |
End Date: | June 2014 |
This is an open-label, single-dose, randomized crossover study of single oral 10-mg tablet
doses administered either after an overnight fast or in combination with a standard high-fat
meal in healthy subjects.
doses administered either after an overnight fast or in combination with a standard high-fat
meal in healthy subjects.
The study will have 2 phases: Prerandomization and Randomization. The Prerandomization Phase
will consist of 2 periods: Screening and Baseline (Baseline Period 1), during which each
subject�s study eligibility will be determined and baseline assessments will be conducted.
During this phase, each eligible subject will be randomized to 1 of 2 treatment sequences to
receive single oral doses of E2006 10 mg under fasted and fed conditions. The Randomization
Phase will consist of 3 periods: administration of the first randomized dose (Treatment
Period 1), baseline for the second randomized dose (Baseline Period 2), and administration
of the second randomized dose (Treatment Period 2).
will consist of 2 periods: Screening and Baseline (Baseline Period 1), during which each
subject�s study eligibility will be determined and baseline assessments will be conducted.
During this phase, each eligible subject will be randomized to 1 of 2 treatment sequences to
receive single oral doses of E2006 10 mg under fasted and fed conditions. The Randomization
Phase will consist of 3 periods: administration of the first randomized dose (Treatment
Period 1), baseline for the second randomized dose (Baseline Period 2), and administration
of the second randomized dose (Treatment Period 2).
Inclusion Criteria
1. Healthy males or females, ages 18 to 55 years
2. Body mass index greater than 18 and less than or equal to 32 kg/m2 at Screening
3. All females must be of nonchildbearing potential, defined as postmenopausal women
(defined as at least 12 months consecutive amenorrhea, in the appropriate age group
and without other known or suspected cause) or subjects who have been sterilized
surgically or who are otherwise proven sterile (eg, bilateral tubal ligation with
surgery at least 6 months prior to dosing, hysterectomy, or bilateral oophorectomy
with surgery at least 2 months prior to dosing). In addition, females must have a
negative serum B-human chorionic gonadotropin test result at Screening.
4. Males who are not abstinent or have undergone a successful vasectomy, who are
partners of women of childbearing potential must use, or their partners must use a
highly effective method of contraception (eg, condom plus spermicide, condom plus
diaphragm with spermicide, intrauterine device starting at least 1 menstrual cycle
prior to starting study drug and throughout the entire study period and for 30 days
[longer if appropriate] after the last dose of study drug)
5. Are willing and able to comply with all aspects of the protocol
6. Provide written informed consent
Exclusion Criteria
1. Any subject that has a known history of malaria or has traveled to a country with
known malarial risk (ie, is designated as "high" or "moderate" risk country according
to the list available at http://www.cdc.gov/malaria) within the last year
2. Subjects with a history of bowel resection, any malabsorptive disorder, severe
gastroparesis, or any gastrointestinal procedure for the purpose of weight loss
(including Lapband(TM)), which would slow gastric emptying and potentially affect PK
profiles of E2006
3. Subjects with a known history of clinically significant drug or food allergies or a
known allergy or hypersensitivity to capsule or tablet ingredients
4. Subjects who experienced a weight loss or gain of greater than 10% between Screening
and prior to dosing
5. Subjects who had a clinically significant illness that required medical treatment
within 8 weeks or a clinically significant infection within 4 weeks of dosing
6. Subjects with any clinically abnormal symptom or organ impairment found in medical
history, symptoms or signs, vital sign measurements, electrocardiogram (ECG)
findings, or laboratory test results that require medical treatment found in medical
history or at screening and baseline
7. Subjects known to be positive for human immunodeficiency virus, or subjects who have
positive hepatitis B or hepatitis C screening test results
8. Subjects who have a history of drug or alcohol dependency or abuse (as defined by The
Diagnostic and Statistical Manual of Mental Disorders V criteria) within
approximately 2 years prior to Screening, or who have a positive urine drug test
result at Screening or Baseline
9. Subjects who received blood products within 4 weeks, donated blood within 8 weeks, or
donated plasma within 1 week of dosing
10. Subjects who used hormonal replacement therapy within 3 months prior to dosing
11. Subjects who used any drugs, over-the-counter medications, nutritional supplements
(eg, products containing St. John's wort), excessive doses of vitamins (in the
opinion of the principal investigator), herbal preparations, or foods or beverages
known to modulate cytochrome P450 ([CYP] eg, CYP3A4) or transporters within 4 weeks
prior to dosing, or who are unwilling to abstain from using these during the study
12. Subjects who engaged in intense physical activity within 1 week prior to Baseline
(eg, weight training)
13. Subjects who smoke or have used tobacco- or nicotine-containing products within 3
months prior to dosing
14. Subjects who habitually consume more than 400-mg caffeine per day
15. Subjects who participated (received investigational product) in another clinical
trial less than 1 month (or 5 elimination half-lives of the investigational product)
prior to dosing or who are currently enrolled in another clinical trial
16. Subjects with a disease that may influence the outcome of the study, such as
psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney,
respiratory system, endocrine system, hematological system, neurological system, or
cardiovascular system, or subjects who have a congenital abnormality in metabolism,
or subjects who have any condition that would make him or her, in the opinion of the
investigator, unsuitable for the study or who, in the opinion of the investigator,
are not likely to complete the study for any reason
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