A Study to Determine the Effect of a High-Fat Meal on the Rate and Extent of E2006 Absorption in Healthy Subjects

NCT02089412 | Completed Phase 1

• 1 other identifier: E2006-A001-008
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Subjects

Keywords

Healthy Subjects; Absorption; High-Fat Meal

Outcome Measures

Primary Outcomes (4)

• Pharmacokinetics of E2006: AUC(t-0)

  Up to Day 15 (336 hours)

• Pharmacokinetics of E2006: AUC(t-inf)

  Up to Day 15 (336 hours)

• Pharmacokinetics of E2006: Maximum Concentration (Cmax)

  Up to Day 15 (336 hours)

• Pharmacokinetics of E2006: time attain to Cmax (tmax)

  Up to Day 15 (336 hours)

Study Arms (2)

E2006: fed conditions

EXPERIMENTAL

E2006 10-mg will be administered as a single dose under fed treatment conditions.

Drug: E2006

E2006: fasted conditions

EXPERIMENTAL

E2006 10-mg will be administered as a single dose under fasted treatment conditions.

Drug: E2006

Interventions

E2006 DRUG

E2006: fasted conditions; E2006: fed conditions

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males or females, ages 18 to 55 years
• Body mass index greater than 18 and less than or equal to 32 kg/m2 at Screening
• 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.
• 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)
• Are willing and able to comply with all aspects of the protocol
• Provide written informed consent

You may not qualify if:

• 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
• 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
• Subjects with a known history of clinically significant drug or food allergies or a known allergy or hypersensitivity to capsule or tablet ingredients
• Subjects who experienced a weight loss or gain of greater than 10% between Screening and prior to dosing
• Subjects who had a clinically significant illness that required medical treatment within 8 weeks or a clinically significant infection within 4 weeks of dosing
• 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
• Subjects known to be positive for human immunodeficiency virus, or subjects who have positive hepatitis B or hepatitis C screening test results
• 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
• Subjects who received blood products within 4 weeks, donated blood within 8 weeks, or donated plasma within 1 week of dosing
• Subjects who used hormonal replacement therapy within 3 months prior to dosing
• 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
• Subjects who engaged in intense physical activity within 1 week prior to Baseline (eg, weight training)
• Subjects who smoke or have used tobacco- or nicotine-containing products within 3 months prior to dosing
• Subjects who habitually consume more than 400-mg caffeine per day
• 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

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (1)

PPD Development LLC

Austin, Texas, 78744, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2014
• First Posted: March 17, 2014
• Study Start: February 1, 2014
• Primary Completion: May 1, 2014
• Study Completion: June 1, 2014
• Last Updated: November 3, 2015

Record last verified: 2015-11

Locations

US (1)