Healthy VolunteersPhase 1NCT05745207
A Study To Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2086 in Healthy Adult and Elderly Participants
A Phase 1 study testing E2086 in people with Healthy Volunteers, run by Eisai Inc. at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate the safety and tolerability of E2086 following administration of a single oral doses in healthy adult and elderly participants. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- E2086
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2023to 18 Jan 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non-smoking, male or female, age greater than or equal to (>=) 18 years to less than or equal to (<=) 55 years old (greater than [>] 65 years old for Part B) at the time of informed consent. To be considered non-smokers, participants must have discontinued smoking for at least 4 weeks before dosing.
- Reports regular bedtime, defined as the time the participant attempts to sleep, between 21:00 and midnight, based on sleep diary data from the Screening Period.
- Reports regular waketime, defined as the time the participant gets out of bed for the day, between 05:00 and 10:00, based on sleep diary data from the Screening Period.
- Body mass index (BMI) >=18 to less than (<) 30 kilogram per square meter (kg/m^2) at Screening.
Who cannot join
- Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing
- Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin [ß-hCG] (or human chorionic gonadotropin [hCG]) test with a minimum sensitivity of 25 international units per liter (IU/L) or equivalent units of ß-hCG [or hCG]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the dose of study drug.
- All females who are of childbearing potential:
- All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (that is, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing).
- Males who have not had a successful vasectomy (confirmed azoospermia) or they and their female partners do not meet the criteria above (that is, not of childbearing potential or practicing highly effective contraception throughout the study period or for 28 days after study drug discontinuation). No sperm donation is allowed during the study period or for 90 days after study drug discontinuation
- Evidence of disease that may influence the outcome of the study within 4 weeks before dosing (example, psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system)
Show all 40Show fewer
- Any history of a congenital abnormality in metabolism at Screening
- Any history of seizure, epilepsy, or non-epileptic seizures
- Any history of surgery that may affect PK profiles of E2086 (example, hepatectomy, nephrotomy, digestive organ resection) at Screening
- Any clinically abnormal symptom or organ impairment found by medical history, physical examinations, vital signs, ECG finding, or laboratory test results that require medical treatment at Screening or Baseline
- Liver function test values outside of the normal laboratory defined range at Screening or Baseline.
- Any history of liver disease.
- Known history of liver function test values outside of the normal laboratory defined range within the last 6 months.
- Evidence of clinically significant disease (example, cardiac, respiratory, gastrointestinal, renal disease, sleep disorders) that in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments
- A prolonged QT/QTc interval (QTc >450 milliseconds [ms]) demonstrated on ECG at Screening or Baseline (based on average of triplicate ECGs). A history of risk factors for torsade de pointes (example, heart failure, hypokalemia, family history of long QT Syndrome) or the use of concomitant medications that prolonged the QT/QTc interval
- Left bundle branch block at Screening or Baseline
- Persistent systolic BP >130 or <100 millimeters of mercury (mmHg) or diastolic BP >85 or <50 mmHg at Screening or Baseline (based on BP measured on at least 3 occasions over 2 weeks)
- Persistent heart rate (HR) less than 50 beats/min or more than 100 beats/min at Screening or Baseline (based on HR measured on at least 3 occasions over 2 weeks)
- History of myocardial infarction, ischemic heart disease, or cardiac failure at Screening
- History of clinically significant arrhythmia or uncontrolled arrhythmia
- Known history of clinically significant drug allergy at Screening or Baseline
- Known history of food allergies or presently experiencing significant seasonal or perennial allergy at Screening or Baseline
- Known to be human immunodeficiency virus (HIV) positive at Screening
- Active or chronic viral hepatitis (A, B, or C) as demonstrated by positive serology at Screening
- Active Epstein Barr virus (EBV) as demonstrated by positive serology at Screening
- History of drug or alcohol dependency or abuse within the 2 years before Screening, or those who have a positive drug test or alcohol test at Screening or Baseline
- Intake of caffeinated beverages or food within 72 hours before dosing
- Intake of herbal preparations containing St. John's Wort within 4 weeks before dosing
- Any lifetime history of suicidal ideation or any lifetime history of suicidal behaviour as indicated by the Columbia-Suicide Severity Rating Scale (C-SSRS).
- Any lifetime history of psychiatric disease (including but not limited to depression or other mood disorders, bipolar disorder, psychotic disorders, including schizophrenia, panic attacks, anxiety disorders). The absence of a history of psychiatric disease should be documented by a checklist in the eCRF.
- Any current psychiatric symptoms as indicated by a standard screening tool (Diagnostic and Statistical Manual of Mental Disorders [DSM-5] Self-Rated Level 1 Cross-Cutting Symptom Measure - Adult)
- Participants who's 1st degree (blood) relatives have lifetime diagnosis of bipolar type I disorder or a psychotic disorder.
- Use of prescription drugs within 4 weeks before dosing
- Intake of over the counter (OTC) medications within 2 weeks before dosing
- Currently enrolled in another clinical study or used any investigational drug or device within 30 days or 5 half-lives, whichever is longer, preceding informed consent
- Receipt of blood products within 4 weeks, or donation of blood within 8 weeks, or donation of plasma within 1 week of dosing
- Epileptiform discharges on screening EEG
- History of formally diagnosed moderate to severe obstructive sleep apnea, current use of continuous positive airway pressure, or symptomatic restless legs syndrome.
- Exposure within the last 14 days to an individual with confirmed or probable COVID-19 or symptoms within the last 14 days that are on the most recent Centers for Disease Control and Prevention (CDC) list of COVID symptoms or any other reason to consider the participant at potential risk for COVID-19 infection.
- Exposure to any biologic drug within 90 days or at least 5 half-lives (whichever is longer), or within 4 weeks for vaccines, before Screening, with the exception of flu (7 days before dosing) and COVID-19 vaccination (14 days before dosing until after the Follow-up visit).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A First-In-Human, Two-Part Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2086 in Healthy Adult and Elderly Subjects
The primary objective of this study is to evaluate the safety and tolerability of E2086 following administration of a single oral doses in healthy adult and elderly participants.
- Conditions
- Healthy Volunteers
- Being tested
- E2086, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E2086Drug
E2086 tablets.
PlaceboDrug
E2086 matched placebo tablets.
| Study group | Role | What they receive |
|---|---|---|
| Part A, Cohort 1: E2086 1 mg or Placebo | Experimental | Participants will receive 1 milligram (mg) (2*0.5 mg) E2086 or E2086 matched placebo, tablets, orally, once on Day 1. Receives: Drug: E2086; Drug: Placebo |
| Part A, Cohort 2: E2086 2.5 mg or Placebo | Experimental | Participants will receive 2.5 mg (5*0.5 mg) E2086 or E2086 matched placebo, tablets, orally, once on Day 1. Receives: Drug: E2086; Drug: Placebo |
| Part A, Cohort 3: E2086 5 mg or Placebo | Experimental | Participants will receive 5 mg (1*5 mg) E2086 or E2086 matched placebo, tablets, orally, once on Day 1. Receives: Drug: E2086; Drug: Placebo |
| Part A, Cohort 4: E2086 10 mg or Placebo | Experimental | Participants will receive 10 mg (2*5 mg) E2086 or E2086 matched placebo, tablets, orally, once on Day 1. Receives: Drug: E2086; Drug: Placebo |
| Part A, Cohort 5: E2086 25 mg or Placebo | Experimental | Participants will receive 25 mg (1*25 mg) E2086 or E2086 matched placebo, tablets, orally, once on Day 1. Receives: Drug: E2086; Drug: Placebo |
| Part A, Cohort 6: E2086 50 mg or Placebo | Experimental | Participants will receive 50 mg (2*25 mg) E2086 or E2086 matched placebo, tablets, orally, once on Day 1. Receives: Drug: E2086; Drug: Placebo |
| Part A, Cohort 7: E2086 100 mg or Placebo | Experimental | Participants will receive 100 mg (4*25 mg) E2086 or E2086 matched placebo, tablets, orally, once on Day 1. Receives: Drug: E2086; Drug: Placebo |
| Part B, Cohort 8: E2086 25 mg or Placebo | Experimental | Participants will receive 25 mg (1*25 mg) E2086 or E2086 matched placebo, tablets, orally, once on Day 1. Receives: Drug: E2086; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Measured: From Screening up to 10 days
Number of Participants With Serious Adverse Events (SAEs)
Measured: From Screening up to 10 days
Number of Participants With Clinically Significant Abnormal Laboratory Values
Measured: From Screening up to 10 days
Number of Participants With Clinically Significant Abnormal Vital Signs Values
Measured: From Screening up to 10 days
Number of Participants With Clinically Significant Abnormal Electrocardiograms (ECGs) Findings
Measured: From Screening up to 10 days
Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-suicide Severity Rating Scale (C-SSRS)
The C-SSRS is an interview-based rating scale to systematically assess any suicidality, suicidal behavior, or suicidal ideation. Any suicidality is emergence of any suicidal ideation or suicidal behavior. Any suicidal behavior is indicated when response is "yes" for any these questions- actual attempt to suicide, engaged in non-suicidal self-injurious behavior, interrupted attempt, aborted attempt, preparatory acts. Any suicidal ideation is indicated when response is "yes" for any of these questions- wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent to suicide.
Measured: From Screening up to 10 days
Number of Participants With Clinically Significant Abnormal Physical Examination Findings
Measured: From Screening up to 10 days
Number of Participants With Clinically Significant Abnormal Neurological Examination Findings
Measured: From Screening up to 10 days
Number of Participants With Clinically Significant Abnormal Electroencephalogram (EEG) Findings
Measured: Baseline, Days 1 and 2
Secondary outcomes (15)
Cmax: Maximum Observed Plasma Concentration for E2086 and its Metabolites
Measured: Day 1: Pre-dose (0 hour) up to 216 hours post-dose
Tmax: Time to Reach Maximum Observed Plasma Concentration (Cmax) for E2086 and its Metabolites
Measured: Day 1: Pre-dose (0 hour) up to 216 hours post-dose
AUC(0-24h): Area Under the Plasma Concentration-time Curve From Time Zero to 24 hours Post-dose for E2086 and its Metabolites
Measured: Day 1: Pre-dose (0 hour) up to 24 hours post-dose
AUC(0-t): Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration for E2086 and its Metabolites
Measured: Day 1: Pre-dose (0 hour) up to 216 hours post-dose
AUC(0-72h): Area Under the Plasma Concentration-time Curve From Time Zero to 72 hours Post-dose for E2086 and its Metabolites
Measured: Day 1: Pre-dose (0 hour) up to 72 hours post-dose
AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time Zero to Infinite for E2086 and its Metabolites
Measured: Day 1: Pre-dose (0 hour) up to 216 hours post-dose
t1/2: Terminal Elimination Phase Half-life for E2086 and its Metabolites
Measured: Day 1: Pre-dose (0 hour) up to 216 hours post-dose
CL/F: Apparent Total Clearance for E2086
Measured: Day 1: Pre-dose (0 hour) up to 216 hours post-dose
Vz/F: Apparent Volume of Distribution at Terminal Phase for E2086
Measured: Day 1: Pre-dose (0 hour) up to 216 hours post-dose
MRp: Ratio of Plasma AUC(0-inf) of Metabolite to E2082, Corrected for Molecular Weights
Measured: Day 1: Pre-dose (0 hour) up to 216 hours post-dose
Mean Change in Subjective Sleep Onset Latency (sSOL)
sSOL is a participant-reported estimate of the amount of time (in minutes) it took the participant to fall asleep the prior evening.
Measured: Screening up to Study Day 7
Ae: Cumulative Amount of E2086 and its Metabolites Excreted in Urine
Measured: Day 1: Pre-dose (0 hour) up to 120 hours post-dose
CLR: Renal Clearance of E2086 and its Metabolites
Measured: Day 1: Pre-dose (0 hour) up to 120 hours post-dose
Fe: Percent (%) of E2086 and its Metabolites Excreted in Urine
Measured: Day 1: Pre-dose (0 hour) up to 120 hours post-dose
MRU: Ratio of Ae Urine Concentration of Metabolite to E2082, Corrected for Molecular Weights
Measured: Day 1: Pre-dose (0 hour) up to 120 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start20 Feb 2023
- Primary completion18 Jan 2024
- Study completion18 Jan 2024
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 53 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
- NCT05745207
- Sponsor's protocol ID
- E2086-A001-001
- Status last verified
- May 2024
- First submitted
- 16 Feb 2023
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-In-Human, Two-Part Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2086 in Healthy Adult and Elderly Subjects
- ClinicalTrials.gov ID
- NCT05745207
- Acronym / sponsor ID
- E2086-A001-001
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 18 Jan 2024 (actual)
- Study completion
- 18 Jan 2024 (actual)
- First posted
- 27 Feb 2023 (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.
The primary objective of this study is to evaluate the safety and tolerability of E2086 following administration of a single oral doses in healthy adult and elderly participants.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Part A, Cohort 1: E2086 1 mg or Placebo | Experimental | Drug: E2086, Drug: PlaceboParticipants will receive 1 milligram (mg) (2*0.5 mg) E2086 or E2086 matched placebo, tablets, orally, once on Day 1. |
| Part A, Cohort 2: E2086 2.5 mg or Placebo | Experimental | Drug: E2086, Drug: PlaceboParticipants will receive 2.5 mg (5*0.5 mg) E2086 or E2086 matched placebo, tablets, orally, once on Day 1. |
| Part A, Cohort 3: E2086 5 mg or Placebo | Experimental | Drug: E2086, Drug: PlaceboParticipants will receive 5 mg (1*5 mg) E2086 or E2086 matched placebo, tablets, orally, once on Day 1. |
| Part A, Cohort 4: E2086 10 mg or Placebo | Experimental | Drug: E2086, Drug: PlaceboParticipants will receive 10 mg (2*5 mg) E2086 or E2086 matched placebo, tablets, orally, once on Day 1. |
| Part A, Cohort 5: E2086 25 mg or Placebo | Experimental | Drug: E2086, Drug: PlaceboParticipants will receive 25 mg (1*25 mg) E2086 or E2086 matched placebo, tablets, orally, once on Day 1. |
| Part A, Cohort 6: E2086 50 mg or Placebo | Experimental | Drug: E2086, Drug: PlaceboParticipants will receive 50 mg (2*25 mg) E2086 or E2086 matched placebo, tablets, orally, once on Day 1. |
| Part A, Cohort 7: E2086 100 mg or Placebo | Experimental | Drug: E2086, Drug: PlaceboParticipants will receive 100 mg (4*25 mg) E2086 or E2086 matched placebo, tablets, orally, once on Day 1. |
| Part B, Cohort 8: E2086 25 mg or Placebo | Experimental | Drug: E2086, Drug: PlaceboParticipants will receive 25 mg (1*25 mg) E2086 or E2086 matched placebo, tablets, orally, once on Day 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Non-smoking, male or female, age greater than or equal to (>=) 18 years to less than or equal to (<=) 55 years old (greater than [>] 65 years old for Part B) at the time of informed consent. To be considered non-smokers, participants must have discontinued smoking for at least 4 weeks before dosing.
- Reports regular bedtime, defined as the time the participant attempts to sleep, between 21:00 and midnight, based on sleep diary data from the Screening Period.
- Reports regular waketime, defined as the time the participant gets out of bed for the day, between 05:00 and 10:00, based on sleep diary data from the Screening Period.
- Body mass index (BMI) >=18 to less than (<) 30 kilogram per square meter (kg/m^2) at Screening.
Key exclusion criteria (40 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
- Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin [ß-hCG] (or human chorionic gonadotropin [hCG]) test with a minimum sensitivity of 25 international units per liter (IU/L) or equivalent units of ß-hCG [or hCG]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the dose of study drug.
- All females who are of childbearing potential:
- Males who have not had a successful vasectomy (confirmed azoospermia) or they and their female partners do not meet the criteria above (that is, not of childbearing potential or practicing highly effective contraception throughout the study period or for 28 days after study drug discontinuation). No sperm donation is allowed during the study period or for 90 days after study drug discontinuation
- Evidence of disease that may influence the outcome of the study within 4 weeks before dosing (example, psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system)
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 |
|---|---|---|
| E2086E2086 tablets. | Drug | Part A, Cohort 1: E2086 1 mg or Placebo, Part A, Cohort 2: E2086 2.5 mg or Placebo, Part A, Cohort 3: E2086 5 mg or Placebo, Part A, Cohort 4: E2086 10 mg or Placebo, Part A, Cohort 5: E2086 25 mg or Placebo, Part A, Cohort 6: E2086 50 mg or Placebo, Part A, Cohort 7: E2086 100 mg or Placebo, Part B, Cohort 8: E2086 25 mg or Placebo |
| PlaceboE2086 matched placebo tablets. | Drug | Part A, Cohort 1: E2086 1 mg or Placebo, Part A, Cohort 2: E2086 2.5 mg or Placebo, Part A, Cohort 3: E2086 5 mg or Placebo, Part A, Cohort 4: E2086 10 mg or Placebo, Part A, Cohort 5: E2086 25 mg or Placebo, Part A, Cohort 6: E2086 50 mg or Placebo, Part A, Cohort 7: E2086 100 mg or Placebo, Part B, Cohort 8: E2086 25 mg or Placebo |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: From Screening up to 10 days
Number of Participants With Serious Adverse Events (SAEs)
Time frame: From Screening up to 10 days
Number of Participants With Clinically Significant Abnormal Laboratory Values
Time frame: From Screening up to 10 days
Number of Participants With Clinically Significant Abnormal Vital Signs Values
Time frame: From Screening up to 10 days
Number of Participants With Clinically Significant Abnormal Electrocardiograms (ECGs) Findings
Time frame: From Screening up to 10 days
Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-suicide Severity Rating Scale (C-SSRS)
Time frame: From Screening up to 10 days
The C-SSRS is an interview-based rating scale to systematically assess any suicidality, suicidal behavior, or suicidal ideation. Any suicidality is emergence of any suicidal ideation or suicidal behavior. Any suicidal behavior is indicated when response is "yes" for any these questions- actual attempt to suicide, engaged in non-suicidal self-injurious behavior, interrupted attempt, aborted attempt, preparatory acts. Any suicidal ideation is indicated when response is "yes" for any of these questions- wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent to suicide.
Number of Participants With Clinically Significant Abnormal Physical Examination Findings
Time frame: From Screening up to 10 days
Number of Participants With Clinically Significant Abnormal Neurological Examination Findings
Time frame: From Screening up to 10 days
Number of Participants With Clinically Significant Abnormal Electroencephalogram (EEG) Findings
Time frame: Baseline, Days 1 and 2
15 secondary outcomes
Cmax: Maximum Observed Plasma Concentration for E2086 and its Metabolites
Time frame: Day 1: Pre-dose (0 hour) up to 216 hours post-dose
Tmax: Time to Reach Maximum Observed Plasma Concentration (Cmax) for E2086 and its Metabolites
Time frame: Day 1: Pre-dose (0 hour) up to 216 hours post-dose
AUC(0-24h): Area Under the Plasma Concentration-time Curve From Time Zero to 24 hours Post-dose for E2086 and its Metabolites
Time frame: Day 1: Pre-dose (0 hour) up to 24 hours post-dose
AUC(0-t): Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration for E2086 and its Metabolites
Time frame: Day 1: Pre-dose (0 hour) up to 216 hours post-dose
AUC(0-72h): Area Under the Plasma Concentration-time Curve From Time Zero to 72 hours Post-dose for E2086 and its Metabolites
Time frame: Day 1: Pre-dose (0 hour) up to 72 hours post-dose
AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time Zero to Infinite for E2086 and its Metabolites
Time frame: Day 1: Pre-dose (0 hour) up to 216 hours post-dose
t1/2: Terminal Elimination Phase Half-life for E2086 and its Metabolites
Time frame: Day 1: Pre-dose (0 hour) up to 216 hours post-dose
CL/F: Apparent Total Clearance for E2086
Time frame: Day 1: Pre-dose (0 hour) up to 216 hours post-dose
Vz/F: Apparent Volume of Distribution at Terminal Phase for E2086
Time frame: Day 1: Pre-dose (0 hour) up to 216 hours post-dose
MRp: Ratio of Plasma AUC(0-inf) of Metabolite to E2082, Corrected for Molecular Weights
Time frame: Day 1: Pre-dose (0 hour) up to 216 hours post-dose
Mean Change in Subjective Sleep Onset Latency (sSOL)
Time frame: Screening up to Study Day 7
Ae: Cumulative Amount of E2086 and its Metabolites Excreted in Urine
Time frame: Day 1: Pre-dose (0 hour) up to 120 hours post-dose
CLR: Renal Clearance of E2086 and its Metabolites
Time frame: Day 1: Pre-dose (0 hour) up to 120 hours post-dose
Fe: Percent (%) of E2086 and its Metabolites Excreted in Urine
Time frame: Day 1: Pre-dose (0 hour) up to 120 hours post-dose
MRU: Ratio of Ae Urine Concentration of Metabolite to E2082, Corrected for Molecular Weights
Time frame: Day 1: Pre-dose (0 hour) up to 120 hours post-dose
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 2 Oct 2024.
- Individual participant dataSharing planned: Yes. Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
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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 E2086 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 4 inclusion and 40 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 2 Oct 2024. 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?
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (time frame: From Screening up to 10 days). The study lists 9 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 2 Oct 2024.