Healthy SubjectsPhase 1NCT02089412
A Study to Determine the Effect of a High-Fat Meal on the Rate and Extent of E2006 Absorption in Healthy Subjects
A Phase 1 study testing E2006 in people with Healthy Subjects, run by Eisai Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- E2006
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Jun 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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).
- Conditions
- Healthy Subjects
- Being tested
- E2006
- Keywords
- Healthy Subjects, Absorption, High-Fat Meal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E2006Drug
| Study group | Role | What they receive |
|---|---|---|
| E2006: fed conditions | Experimental | E2006 10-mg will be administered as a single dose under fed treatment conditions. Receives: Drug: E2006 |
| E2006: fasted conditions | Experimental | E2006 10-mg will be administered as a single dose under fasted treatment conditions. Receives: Drug: E2006 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of E2006: AUC(t-0)
Measured: Up to Day 15 (336 hours)
Pharmacokinetics of E2006: AUC(t-inf)
Measured: Up to Day 15 (336 hours)
Pharmacokinetics of E2006: Maximum Concentration (Cmax)
Measured: Up to Day 15 (336 hours)
Pharmacokinetics of E2006: time attain to Cmax (tmax)
Measured: Up to Day 15 (336 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionMay 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02089412
- Sponsor's protocol ID
- E2006-A001-008
- Status last verified
- Nov 2015
- First submitted
- 14 Mar 2014
- Last updated
- 3 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Determine the Effect of a High-Fat Meal on the Rate and Extent of E2006 Absorption in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02089412
- Acronym / sponsor ID
- E2006-A001-008
- Conditions
- Healthy Subjects
- Keywords
- Healthy Subjects, Absorption, High-Fat Meal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- May 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 17 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E2006: fed conditions | Experimental | Drug: E2006E2006 10-mg will be administered as a single dose under fed treatment conditions. |
| E2006: fasted conditions | Experimental | Drug: E2006E2006 10-mg will be administered as a single dose under fasted treatment conditions. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E2006 | Drug | E2006: fasted conditions, E2006: fed conditions |
Primary outcome
Pharmacokinetics of E2006: AUC(t-0)
Time frame: Up to Day 15 (336 hours)
Pharmacokinetics of E2006: AUC(t-inf)
Time frame: Up to Day 15 (336 hours)
Pharmacokinetics of E2006: Maximum Concentration (Cmax)
Time frame: Up to Day 15 (336 hours)
Pharmacokinetics of E2006: time attain to Cmax (tmax)
Time frame: Up to Day 15 (336 hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing E2006 in people with Healthy Subjects, run by Eisai Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics of E2006: AUC(t-0) (time frame: Up to Day 15 (336 hours)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2015.