Healthy ParticipantsPhase 1NCT03055962
Study to Evaluate the Safety and Tolerability of a Once Daily Dose of 50 mg E2609 in Healthy Japanese Subjects
A Phase 1 study testing E2609 in people with Healthy Participants, run by Eisai Co., Ltd. at 1 site in Japan.
Trial summary
Study E2609-J081-014 is a single-center, randomized, double-blind, placebo-controlled study conducted to evaluate the safety and tolerability of multiple oral doses of E2609 50 milligrams (mg), administered once daily for 14 days, in healthy Japanese participants aged 50 to 85 years. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- E2609
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteJapan
- Study dates
- 14 Feb 2017to 11 Apr 2017
- 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 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males and females
- Aged 50 to 85 years, inclusive at time of consent
- Body mass index (BMI) of 17.6 to 32 kilograms per meters squared (kg/m^2) at Screening
Who cannot join
- Personal or family history of seizure disorder, symptomatic seizures (not including a history of simple febrile seizures in childhood) or any past or present medical condition which, in the opinion of the investigator has the potential to reduce seizure threshold (eg, history of head trauma or concussion, previous alcohol abuse, substance abuse)
- A history of cerebrovascular accident or non-vasovagal-related loss of consciousness
- Any clinically significant findings on neurological examination
- A family history of Long QT Syndrome or a presence of other risk factors for Torsades de Pointes (TDP), such as hypokalemia, hypomagnesemia, or hypocalcemia
- History of cardiac arrhythmias, ischemic heart disease, or cerebrovascular disease
- A history of gastrointestinal surgery that may affect the pharmacokinetic profile of E2609 (eg, hepatectomy, nephrotomy, digestive organ resection)
- A known history of clinically significant drug or food allergies or presently experiencing significant seasonal allergy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multiple Dose Study to Evaluate the Safety and Tolerability of a Once Daily Dose of 50 mg E2609 in Healthy Japanese Subjects
Study E2609-J081-014 is a single-center, randomized, double-blind, placebo-controlled study conducted to evaluate the safety and tolerability of multiple oral doses of E2609 50 milligrams (mg), administered once daily for 14 days, in healthy Japanese participants aged 50 to 85 years.
- Conditions
- Healthy Participants
- Being tested
- E2609, Placebo
- Keywords
- Healthy Participants, E2609, Pharmacokinetics, Japan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E2609Drug
tablet
PlaceboDrug
tablet
| Study group | Role | What they receive |
|---|---|---|
| E2609 50 mg | Experimental | Participants will receive E2609 50 milligrams (mg) orally once a day for 14 days. Receives: Drug: E2609 |
| Placebo | Placebo comparator | Participants will receive matching placebo orally once a day for 14 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with any serious adverse event and number of participants with any non-serious adverse event
An adverse event is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A serious adverse event is defined as any adverse event occurring at any dose that results in any of the following outcomes: results in death; is life threatening; results in inpatient hospitalization or prolongation of existing hospitalization; results in a persistent or significant incapacity or substantial disruption of the ability to conduct normal life function; results in a congenital anomaly/birth defect; or can be defined as any other important medical event.
Measured: up to Day 35 (Termination/Visit 5)
Number of participants with an abnormal, clinically significant laboratory test value
Laboratory test values will be assigned a low/normal/high (LNH) classification according to whether the value was below (L), within (N), or above (H) the laboratory parameter's reference range. Clinical significance will be determined by the Investigator.
Measured: Screening; Baseline; Days 4, 8, 11, 14, 20 (Out-Patient Follow-up), and 35 (Termination/Visit 5); up to Day 62 (unscheduled Follow-up visits)
Number of participants with an abnormal, clinically significant vital sign value
Vital sign measurements (ie, systolic and diastolic blood pressure [BP] [millimeters of mercury (mmHg)], heart rate [beats per minute], respiratory rate [breaths per minute], body temperature [centigrade]) will be obtained in the supine position by a validated method. Clinical significance will be determined by the Investigator.
Measured: Screening; Baseline; up to Day 62
Number of participants with an abnormal, clinically significant electrocardiogram (ECG) finding
Twelve-lead standard ECGs will be recorded in triplicate. ECGs will be recorded after the participant has been in the supine position for at least 10 minutes before and during the reading. In addition, all ECGs will be obtained before blood draws. Clinical significance will be determined by the Investigator.
Measured: Screening; Baseline; up to Day 62
Clinical assessment of suicidality per the suicidality rating scale
The suicidality rating scale will rate a participant's degree of suicidal ideation on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent." The decision to classify an isolated suicidality rating scale response as an adverse event will be exercised through medical and scientific judgment.
Measured: Baseline (Day -1), 24 hours after dosing (Day 2), Day 15, Day 20, Day 35 (Termination/Visit 5), up to Day 62 (unscheduled Follow-up visits)
Mean quality of sleep score per the Waketime Questionnaire, if necessary
Participants reporting adverse events (AEs) relating to abnormal dreams, nightmares, or sleep terrors will be questioned using the Waketime Questionnaire which is comprised of 5 individual questions. A participant is asked to rate the quality of their sleep as: 1, Very sound or restful; 2, Sound or restful; 3, Average quality; 4, Restless; or 5, Very restless.
Measured: up to Day 62
Secondary outcomes (9)
Mean maximum observed concentration (Cmax) of E2609 and metabolites on Day 1 and Day 14
Cmax is defined as the maximum observed concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administered. Using non-compartmental analysis, plasma concentrations of E2609 and metabolites will be analyzed to determine Cmax. Cmax will be summarized as the mean and standard deviation for all participants.
Measured: Days 1 and 14: predose; 1, 2, 3, 4, 6, and 10 hours postdose
Mean minimum observed concentration (Cmin) of E2609 and metabolites on Day 1 and Day 14
Cmin is defined as the minimum observed concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administered. Using non-compartmental analysis, plasma concentrations of E2609 and metabolites will be analyzed to determine Cmin. Cmin will be summarized as the mean and standard deviation for all participants.
Measured: Days 1 and 14: predose; 1, 2, 3, 4, 6, and 10 hours postdose
Median time from dosing to reach Cmax (tmax) of E2609 and metabolites on Day 1 and Day 14
Tmax is defined as the time from dosing to reach the maximum observed concentration a drug achieves in a specified compartment or test area of the body after the drug has been administered. Using non-compartmental analysis, plasma concentrations of E2609 and metabolites will be analyzed to determine Tmax. Tmax will be summarized as the median for all participants.
Measured: Days 1 and 14: predose; 1, 2, 3, 4, 6, and 10 hours postdose
Mean area under the concentration-time curve (AUC) from time 0 to 24 hours for E2609 and metabolites on Day 1 and Day 14
AUC represents the total drug exposure over a defined period of time. Plasma concentrations of E2609 and its metabolites will be analyzed using a non-compartmental analysis approach to determine individual participant estimates of AUC(0-24h). AUC(0-24h) will be summarized as the mean and standard deviation for all participants and will be expressed in nanograms x hour per milliliter (ng*hr/mL).
Measured: Days 1 and 14: 1, 2, 3, 4, 6, 10, and 24 hours postdose
Mean terminal elimination half-life (t1/2) following the last day of dosing (Day 14) of E2609 and metabolites
Terminal half-life is the time it takes for a substance to lose half of its pharmacologic, physiologic, or radiologic activity. Plasma concentrations of E2609 and its metabolites will be analyzed using a non-compartmental analysis approach to determine t1/2. t1/2 will be summarized as the mean and standard deviation for all participants and will be expressed in hours.
Measured: Day 14: 1, 2, 3, 4, 6, 10, 24, 48, 72, 96, and 144 hours postdose
Mean average concentration calculated as AUCss/tau (Css,av), where tau is the dosing interval, of E2609 and metabolites on Day 1 and Day 14
Css,av is the average steady-state concentration of a drug. Steady state will be achieved when the rate of E2609 administration and the rate of E2609 elimination are equal. Plasma concentrations of E2609 and its metabolites will be analyzed using a non-compartmental analysis approach to determine the Css,av.
Measured: Days 1 and 14: 1, 2, 3, 4, 6, 10, and 24 hours postdose
Mean accumulation ratio for AUC, Cmax, and Cmin (Rac) for E2609 and metabolites on Day 1 and Day 14
Rac is equal to the ratio of the AUC during a dosage interval at steady state to the AUC of a dosage interval after the first dose. Plasma concentrations of E2609 and its metabolites will be analyzed using a non-compartmental analysis approach to determine Rac. Rac will be summarized as the mean and standard deviation for all participants
Measured: Days 1 and 14: 1, 2, 3, 4, 6, 10, and 24 hours postdose
Apparent clearance at steady state (CLss/F) of E2609 on Day 14
CLss/F is the rate and extent of absorption and clearance of E2609 from the plasma. Plasma concentrations of E2609 and metabolites will be analyzed using a non-compartmental analysis approach to determine CLss/F.
Measured: Day 14: 1, 2, 3, 4, 6, 10, 24, 48, 72, 96, and 144 hours postdose
Number of participants with polymorphisms of N-acetyltransferase 2 (NAT2)
NAT2 genotyping will be conducted, and the predicted phenotype (eg, slow, intermediate, or rapid acetylators) will be used in the statistical analysis to evaluate the relative impact of NAT2 polymorphisms on plasma concentrations of E2609 and/or its metabolites.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study start14 Feb 2017
- Primary completion29 Mar 2017
- Study completion11 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03055962
- Sponsor's protocol ID
- E2609-J081-014
- Status last verified
- Apr 2017
- First submitted
- 10 Feb 2017
- Last updated
- 18 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multiple Dose Study to Evaluate the Safety and Tolerability of a Once Daily Dose of 50 mg E2609 in Healthy Japanese Subjects
- ClinicalTrials.gov ID
- NCT03055962
- Acronym / sponsor ID
- E2609-J081-014
- Conditions
- Healthy Participants
- Keywords
- Healthy Participants, E2609, Pharmacokinetics, Japan
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Feb 2017 (actual)
- Primary completion
- 29 Mar 2017 (actual)
- Study completion
- 11 Apr 2017 (actual)
- First posted
- 16 Feb 2017 (actual)
- 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.
Study E2609-J081-014 is a single-center, randomized, double-blind, placebo-controlled study conducted to evaluate the safety and tolerability of multiple oral doses of E2609 50 milligrams (mg), administered once daily for 14 days, in healthy Japanese participants aged 50 to 85 years.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E2609 50 mg | Experimental | Drug: E2609Participants will receive E2609 50 milligrams (mg) orally once a day for 14 days. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive matching placebo orally once a day for 14 days. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy males and females
- Aged 50 to 85 years, inclusive at time of consent
- Body mass index (BMI) of 17.6 to 32 kilograms per meters squared (kg/m^2) at Screening
Key exclusion criteria (7 listed)
- Personal or family history of seizure disorder, symptomatic seizures (not including a history of simple febrile seizures in childhood) or any past or present medical condition which, in the opinion of the investigator has the potential to reduce seizure threshold (eg, history of head trauma or concussion, previous alcohol abuse, substance abuse)
- A history of cerebrovascular accident or non-vasovagal-related loss of consciousness
- Any clinically significant findings on neurological examination
- A family history of Long QT Syndrome or a presence of other risk factors for Torsades de Pointes (TDP), such as hypokalemia, hypomagnesemia, or hypocalcemia
- History of cardiac arrhythmias, ischemic heart disease, or cerebrovascular disease
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 |
|---|---|---|
| E2609tablet | Drug | E2609 50 mg |
| Placebotablet | Drug | Placebo |
Primary outcome
Number of participants with any serious adverse event and number of participants with any non-serious adverse event
Time frame: up to Day 35 (Termination/Visit 5)
An adverse event is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A serious adverse event is defined as any adverse event occurring at any dose that results in any of the following outcomes: results in death; is life threatening; results in inpatient hospitalization or prolongation of existing hospitalization; results in a persistent or significant incapacity or substantial disruption of the ability to conduct normal life function; results in a congenital anomaly/birth defect; or can be defined as any other important medical event.
Number of participants with an abnormal, clinically significant laboratory test value
Time frame: Screening; Baseline; Days 4, 8, 11, 14, 20 (Out-Patient Follow-up), and 35 (Termination/Visit 5); up to Day 62 (unscheduled Follow-up visits)
Laboratory test values will be assigned a low/normal/high (LNH) classification according to whether the value was below (L), within (N), or above (H) the laboratory parameter's reference range. Clinical significance will be determined by the Investigator.
Number of participants with an abnormal, clinically significant vital sign value
Time frame: Screening; Baseline; up to Day 62
Vital sign measurements (ie, systolic and diastolic blood pressure [BP] [millimeters of mercury (mmHg)], heart rate [beats per minute], respiratory rate [breaths per minute], body temperature [centigrade]) will be obtained in the supine position by a validated method. Clinical significance will be determined by the Investigator.
Number of participants with an abnormal, clinically significant electrocardiogram (ECG) finding
Time frame: Screening; Baseline; up to Day 62
Twelve-lead standard ECGs will be recorded in triplicate. ECGs will be recorded after the participant has been in the supine position for at least 10 minutes before and during the reading. In addition, all ECGs will be obtained before blood draws. Clinical significance will be determined by the Investigator.
Clinical assessment of suicidality per the suicidality rating scale
Time frame: Baseline (Day -1), 24 hours after dosing (Day 2), Day 15, Day 20, Day 35 (Termination/Visit 5), up to Day 62 (unscheduled Follow-up visits)
The suicidality rating scale will rate a participant's degree of suicidal ideation on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent." The decision to classify an isolated suicidality rating scale response as an adverse event will be exercised through medical and scientific judgment.
Mean quality of sleep score per the Waketime Questionnaire, if necessary
Time frame: up to Day 62
Participants reporting adverse events (AEs) relating to abnormal dreams, nightmares, or sleep terrors will be questioned using the Waketime Questionnaire which is comprised of 5 individual questions. A participant is asked to rate the quality of their sleep as: 1, Very sound or restful; 2, Sound or restful; 3, Average quality; 4, Restless; or 5, Very restless.
9 secondary outcomes
Mean maximum observed concentration (Cmax) of E2609 and metabolites on Day 1 and Day 14
Time frame: Days 1 and 14: predose; 1, 2, 3, 4, 6, and 10 hours postdose
Mean minimum observed concentration (Cmin) of E2609 and metabolites on Day 1 and Day 14
Time frame: Days 1 and 14: predose; 1, 2, 3, 4, 6, and 10 hours postdose
Median time from dosing to reach Cmax (tmax) of E2609 and metabolites on Day 1 and Day 14
Time frame: Days 1 and 14: predose; 1, 2, 3, 4, 6, and 10 hours postdose
Mean area under the concentration-time curve (AUC) from time 0 to 24 hours for E2609 and metabolites on Day 1 and Day 14
Time frame: Days 1 and 14: 1, 2, 3, 4, 6, 10, and 24 hours postdose
Mean terminal elimination half-life (t1/2) following the last day of dosing (Day 14) of E2609 and metabolites
Time frame: Day 14: 1, 2, 3, 4, 6, 10, 24, 48, 72, 96, and 144 hours postdose
Mean average concentration calculated as AUCss/tau (Css,av), where tau is the dosing interval, of E2609 and metabolites on Day 1 and Day 14
Time frame: Days 1 and 14: 1, 2, 3, 4, 6, 10, and 24 hours postdose
Mean accumulation ratio for AUC, Cmax, and Cmin (Rac) for E2609 and metabolites on Day 1 and Day 14
Time frame: Days 1 and 14: 1, 2, 3, 4, 6, 10, and 24 hours postdose
Apparent clearance at steady state (CLss/F) of E2609 on Day 14
Time frame: Day 14: 1, 2, 3, 4, 6, 10, 24, 48, 72, 96, and 144 hours postdose
Number of participants with polymorphisms of N-acetyltransferase 2 (NAT2)
Time frame: Day 1
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 18 Apr 2017.
- Individual participant dataSharing planned: No
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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 E2609 in people with Healthy Participants, run by Eisai Co., Ltd. at 1 site in Japan.
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 3 inclusion and 7 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 18 Apr 2017. 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 Japan. 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?
Number of participants with any serious adverse event and number of participants with any non-serious adverse event (time frame: up to Day 35 (Termination/Visit 5)). The study lists 6 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 18 Apr 2017.