Healthy VolunteersPhase 1NCT02039089
A Two-Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2006 in Healthy Japanese and White Subjects
A Phase 1 study testing E2006 2.5 mg, E2006 10 mg and E2006 25 mg in people with Healthy Volunteers, run by Eisai Inc. at 1 site in United States.
Trial summary
This study will be a single-center, multiple-dose, randomized, double-blind, placebo-controlled, parallel-group study in healthy male and female subjects. The study will consist of 2 parts: Part A (3 cohorts of healthy Japanese subjects dosed in the evening) and Part B (one cohort of healthy white subjects dosed in… Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- E2006 2.5 mg, E2006 10 mg and E2006 25 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to May 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 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects have to meet all of the following criteria to be included into this study:
- Non-smoking, male or female subjects age greater than or equal to 20 years and less than or equal to 55 years old at the time of informed consent.
- Japanese subjects must have been born in Japan of Japanese parents and Japanese grandparents, must have lived no more than 5 years outside of Japan, and must not have changed their life style or habits, including diet, while living outside of Japan.
- Who report habitual time in bed greater than 7 hours, with lights-out 21:00 to 24:00 hours and lights-on 06:00 to 09:00 hours.
- Who report typical sleep latency of less than or equal to 30 minutes.
- With typical total sleep time greater than or equal to 420 minutes.
- Body mass index (BMI) greater than or equal to 18 and less than or equal to 28 kg/m2 at Screening.
Who cannot join
- Subjects who meet any of the following criteria will be excluded from this study:
- Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing.
- Any subject that has a known history of malaria or has traveled to a country with known malarial risk (ie, countries designated as 'high' or 'moderate' risk according to the list available at http://www.cdc.gov/malaria) within the last year.
- Evidence of disease that may influence the outcome of the study within 4 weeks before dosing (eg, psychiatric disorders, 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).
- Any history of abdominal surgery that may affect PK profiles of E2006 (eg, hepatectomy, nephrotomy, digestive organ resection).
- Any clinically abnormal symptom or organ impairment found by medical history, physical examination, vital sign and, ECG assessments, or laboratory test results that requires medical treatment.
Show all 25Show fewer
- A QTcF interval greater than 450 ms demonstrated on a repeated ECGs (repeated if initial ECG indicates QT greater than 450 ms) at Screening or Baseline.
- A history or a family history of congenital QT prolongation or with a history of risk factors for torsade de pointes (eg, heart failure, hypokalemia, family history of long QT Syndrome), or use of concomitant medications that prolong the QT/QTc interval.
- Any suicidal ideation with intent with or without a plan at Baseline or within 6 months of Baseline (ie, answering "Yes" to questions 4 or 5 on the Suicidal Ideation Section of the C-SSRS).
- Any lifetime suicidal behavior (per the Suicidal Behavior Section of the C-SSRS).
- Known history of clinically significant drug allergy at screening.
- Known history of food allergies or presently (at Screening or Baseline) experiencing significant seasonal or perennial allergy.
- Active viral hepatitis (A, B or C) as demonstrated by positive serology at Screening. Subjects with HIV infection as confirmed verbally.
- History of drug or alcohol dependency or abuse within the 2 years before Screening, or those who have a positive urine drug test or breath (or urine) alcohol test at Screening or Baseline.
- Habitually consumes more than 400 mg caffeine per day. Caffeine consumption must be discontinued for at least 24 hours before Baseline check-in.
- Intake of nutritional supplements, juice, and herbal preparations or other foods or beverages that may affect the various drug metabolizing enzymes and transporters (eg, alcohol, grapefruit, grapefruit juice, grapefruit-containing beverages, apple or orange juice, vegetables from the mustard green family [eg, kale, broccoli, watercress, collard greens, kohlrabi, brussel sprouts, mustard], charbroiled meats) within 1 week before dosing.
- Intake of herbal preparations containing St. John's Wort within 4 weeks before dosing.
- Use of prescription drugs within 4 weeks before dosing.
- Intake of over-the-counter medications within 2 weeks before dosing.
- Currently enrolled in another clinical study or used any investigational drug or device within 30 days preceding initial dose of study drug.
- Receipt of blood products within 4 weeks, donation of blood within 8 weeks, or donation of plasma within 1 week of dosing.
- Engagement in strenuous exercise within 2 weeks before Screening and check-in (eg, marathon running, weight lifting).
- Diagnosis of a sleep disorder (eg, insomnia, obstructive sleep apnea, restless leg syndrome, Periodic Limb movements in Sleep, narcolepsy, circadian rhythm disorder).
- Performed shift work within 2 weeks before Screening.
- Had taken an airline flight across 3 or more time zones in the 7 days before Screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Two-Part, Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2006 in Healthy Japanese and White Subjects
This study will be a single-center, multiple-dose, randomized, double-blind, placebo-controlled, parallel-group study in healthy male and female subjects. The study will consist of 2 parts: Part A (3 cohorts of healthy Japanese subjects dosed in the evening) and Part B (one cohort of healthy white subjects dosed in the evening). The cohorts will be conducted sequentially. Part A will be started first with the 2.5-mg dose cohort, followed by the 10-mg dose cohort and then the 25-mg dose cohort. Part B will be conducted in parallel with the 10-mg cohort of Part A, with the possibility of overlap.
- Conditions
- Healthy Volunteers
- Being tested
- E2006 2.5 mg, E2006 10 mg, E2006 25 mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E2006 2.5 mgDrug
E2006 10 mgDrug
E2006 25 mgDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Part A: dose escalation of E2006 in Japanese subjects from 2.5 mg (1 x 2.5-mg tablet) up to 10 mg (1 x 10-mg tablet) then to 25 mg (2 x 10-mg tablet, 1 x 5-mg tablet). Receives: Drug: E2006 2.5 mg; Drug: E2006 10 mg; Drug: E2006 25 mg |
| 2 | Experimental | Part B: E2006 10 mg for White subjects that will be group matched to the Japanese subjects in the 10 mg period in Part A. Receives: Drug: E2006 10 mg |
| 3 | Placebo comparator | E2006-matched placebo tablets Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic (PK) profiles of E2006
The primary PK parameters are Cmax, tmax, AUC(0-T), AUC(0-24h), and t1/2, derived by non-compartmental analyses using the plasma concentration of E2006 and metabolites (as data permit).
Measured: Up to 49 days
Pharmacodynamic (PD) profile of E2006
acute effects of E2006 on sleepiness in the hour before bedtime as well as next-day residual sleepiness throughout the daytime hours subsequent to each dose using the KSS and PVT. Effects of E2006 on nighttime sleep will be evaluated using PSG. High-precision QT analyses (HPQT) will be performed using data from 24-hour Holter recordings. The time points of Holter readings will be corresponding to the PK time points.
Measured: Up to 49 days
Adverse events (AEs ) as a measure of safety and tolerability
Measured: Up to 49 days
Suicidality as a measure of safety and tolerability
Measured by the columbia suicide severity rating scale (C-SSRS)
Measured: Up to 49 days
Vital signs as a measure of safety and tolerability
Vital sign measurements will include systolic and diastolic blood pressure (BP) and pulse rate
Measured: Up to 49 days
Electrocardiogram (ECG) as a measure of safety and tolerability
Twelve-lead ECGs will be obtained as a measure of safety and tolerability
Measured: Up to 49 days
Laboratory assessments as a measure of safety and tolerability
Measured: Up to 49 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 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
- NCT02039089
- Sponsor's protocol ID
- E2006-A001-003
- Status last verified
- Nov 2015
- First submitted
- 10 Jan 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 Two-Part, Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2006 in Healthy Japanese and White Subjects
- ClinicalTrials.gov ID
- NCT02039089
- Acronym / sponsor ID
- E2006-A001-003
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 17 Jan 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 study will be a single-center, multiple-dose, randomized, double-blind, placebo-controlled, parallel-group study in healthy male and female subjects. The study will consist of 2 parts: Part A (3 cohorts of healthy Japanese subjects dosed in the evening) and Part B (one cohort of healthy white subjects dosed in the evening). The cohorts will be conducted sequentially. Part A will be started first with the 2.5-mg dose cohort, followed by the 10-mg dose cohort and then the 25-mg dose cohort. Part B will be conducted in parallel with the 10-mg cohort of Part A, with the possibility of overlap.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: E2006 2.5 mg, Drug: E2006 10 mg, Drug: E2006 25 mgPart A: dose escalation of E2006 in Japanese subjects from 2.5 mg (1 x 2.5-mg tablet) up to 10 mg (1 x 10-mg tablet) then to 25 mg (2 x 10-mg tablet, 1 x 5-mg tablet). |
| 2 | Experimental | Drug: E2006 10 mgPart B: E2006 10 mg for White subjects that will be group matched to the Japanese subjects in the 10 mg period in Part A. |
| 3 | Placebo comparator | Drug: PlaceboE2006-matched placebo tablets |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Non-smoking, male or female subjects age greater than or equal to 20 years and less than or equal to 55 years old at the time of informed consent.
- Japanese subjects must have been born in Japan of Japanese parents and Japanese grandparents, must have lived no more than 5 years outside of Japan, and must not have changed their life style or habits, including diet, while living outside of Japan.
- Who report habitual time in bed greater than 7 hours, with lights-out 21:00 to 24:00 hours and lights-on 06:00 to 09:00 hours.
- Who report typical sleep latency of less than or equal to 30 minutes.
- With typical total sleep time greater than or equal to 420 minutes.
Key exclusion criteria (25 listed)
- Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing.
- Any subject that has a known history of malaria or has traveled to a country with known malarial risk (ie, countries designated as 'high' or 'moderate' risk according to the list available at http://www.cdc.gov/malaria) within the last year.
- Evidence of disease that may influence the outcome of the study within 4 weeks before dosing (eg, psychiatric disorders, 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).
- Any history of abdominal surgery that may affect PK profiles of E2006 (eg, hepatectomy, nephrotomy, digestive organ resection).
- Any clinically abnormal symptom or organ impairment found by medical history, physical examination, vital sign and, ECG assessments, or laboratory test results that requires medical treatment.
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 2.5 mg | Drug | 1 |
| E2006 10 mg | Drug | 1, 2 |
| E2006 25 mg | Drug | 1 |
| Placebo | Drug | 3 |
Primary outcome
Pharmacokinetic (PK) profiles of E2006
Time frame: Up to 49 days
The primary PK parameters are Cmax, tmax, AUC(0-T), AUC(0-24h), and t1/2, derived by non-compartmental analyses using the plasma concentration of E2006 and metabolites (as data permit).
Pharmacodynamic (PD) profile of E2006
Time frame: Up to 49 days
acute effects of E2006 on sleepiness in the hour before bedtime as well as next-day residual sleepiness throughout the daytime hours subsequent to each dose using the KSS and PVT. Effects of E2006 on nighttime sleep will be evaluated using PSG. High-precision QT analyses (HPQT) will be performed using data from 24-hour Holter recordings. The time points of Holter readings will be corresponding to the PK time points.
Adverse events (AEs ) as a measure of safety and tolerability
Time frame: Up to 49 days
Suicidality as a measure of safety and tolerability
Time frame: Up to 49 days
Measured by the columbia suicide severity rating scale (C-SSRS)
Vital signs as a measure of safety and tolerability
Time frame: Up to 49 days
Vital sign measurements will include systolic and diastolic blood pressure (BP) and pulse rate
Electrocardiogram (ECG) as a measure of safety and tolerability
Time frame: Up to 49 days
Twelve-lead ECGs will be obtained as a measure of safety and tolerability
Laboratory assessments as a measure of safety and tolerability
Time frame: Up to 49 days
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.
Related trials for Healthy Volunteers
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
Recruiting
Effect of a Fermented Dairy Protein With Prebiotic Fiber on GI Complaints
Digestive Health, Quality of Life
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
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 2.5 mg, E2006 10 mg and E2006 25 mg in people with Healthy Volunteers, 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 7 inclusion and 25 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. Some participants in this study may receive a placebo. 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?
Pharmacokinetic (PK) profiles of E2006 (time frame: Up to 49 days). The study lists 7 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.