Healthy SubjectsPhase 1NCT02873156
A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2027 in Healthy Subjects
A Phase 1 study testing E2027 in people with Healthy Subjects, run by Eisai Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of multiple ascending oral doses of E2027 in healthy participants. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- E2027
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2016to 29 Nov 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
- 1. Nonsmoking, male or female, age ≥50 years and ≤85 years old at the time of informed consent 2. Body mass index (BMI) ≥18 and ≤32 kilogram per square meter (kg/m2) at Screening Part B 3. Born in Japan to Japanese parents and grandparents of Japanese descent 4. Lifestyle, including diet, has not changed significantly since leaving Japan Exclusion Criteria
- 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 (documented by a negative beta-human chorionic gonadotropin [beta (ß)-hCG] (or human chorionic gonadotropin [hCG]) test with a minimum sensitivity of 25 International Unit per Liter (IU/L) or equivalent units of ß-hCG [or hCG]). A negative urine pregnancy test is required before the administration of the 1st dose per cohort.
- Females of childbearing potential who:
- Had unprotected sexual intercourse within 30 days before study entry and do not agree to use a highly effective method of contraception (eg, total abstinence, an intrauterine device, a double barrier method [such as condom plus diaphragm with spermicide] or have a vasectomized partner with confirmed azoospermia but hormonal contraceptives are not permitted) throughout the entire study period and for 28 days after study drug discontinuation
- Are currently abstinent, and do not agree to use a double barrier method (as described above) or refrain from sexual activity during the study period or for 28 days after study drug discontinuation NOTE: 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 (ie, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing).
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- Males who have not had a successful vasectomy (confirmed azoospermia) or they and their female partners do not meet the criteria above (ie, 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 28 days after study drug discontinuation
- Medical conditions which are not adequately and stably controlled on stable doses of medications or which, in the clinical opinion of the Principal Investigator (PI), may interfere with study procedures or participant safety within 4 weeks before dosing (eg, psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system, or participants who have a congenital abnormality in metabolism). Participants with the following stable medical conditions, adequately controlled with stable doses of concomitant medications, need not be excluded if in the opinion of the PI, their conditions do not compromise participant safety or study procedures:
- hypertension without cerebrovascular or cardiovascular complications, controlled on not more than 1 antihypertensive drug
- hyperlipidemia without cerebrovascular or cardiovascular complications, controlled with diet or monotherapy medication
- mild, localized diseases of the skin, respiratory tract which do not require systemic medication treatment and without systemic complications
- mild, localized diseases of the eyes which are not symptomatic and do not require systemic medication treatment and without systemic complications
- osteoarthritis which does not require opioids for treatment of pain
- History of cerebrovascular disease (including transient ischemic attack or stroke)
- Any history of abdominal surgery that may affect pharmacokinetic (PK) profiles of E2027 (eg, hepatectomy, nephrectomy, digestive organ resection) at Screening or Baseline
- Any other clinically abnormal symptom or organ impairment found by medical history, physical examinations, vital signs, electrocardiogram (ECG) finding, or laboratory test results that requires medical treatment at Screening or Baseline
- A prolonged QT/QTc interval (QTc >450 millisecond [ms]) demonstrated on ECG at Screening or Baseline (based on average of triplicate ECGs). A history of risk factors for torsade de pointes (eg, 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 blood pressure (BP) >160 millimeter of mercury (mm Hg) or diastolic BP >100 mm Hg at Screening or Baseline (based on BP measured on at least 3 occasions over 2 weeks)
- Persistent heart rate (HR) less than 50 beats/minute (min) or more than 90 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
- 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 viral hepatitis (A, B, or C) 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 urine drug or alcohol test at Screening or Baseline (participants whose positive urine drug test is considered by the investigator and sponsor medical monitor to be due to permitted concomitant medications need not be excluded)
- Participants who smoke or have used tobacco or nicotine-containing products within 4 weeks before to dosing
- A Columbia Suicide Severity Rating Scale (C-SSRS) suicidal ideation score of 4 or 5 at Screening or Baseline or for the period within 6 months before to Screening or Baseline or any lifetime suicidal behavior
- 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
- Engagement in strenuous exercise within 2 weeks before check-in (eg, marathon runners, weight lifters)
- Any contraindications to cerebrospinal fluid (CSF) sampling by lumbar puncture (LP)
- Participants with platelet count <60,000, international normalized ratio (INR) >1.2, or partial thromboplastin time (PTT) > upper limit of normal (ULN) at Screening
- Intake of caffeinated beverages or caffeinated food within 72 hours before dosing
- 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], and charbroiled meats) within 1 week before dosing
- Intake of herbal preparations containing St. John's Wort within 4 weeks before dosing.
- Intake of over-the-counter (OTC) medications within 14 days (or 5 half-lives, whichever is longer) before dosing unless the principal investigator and sponsor medical monitor consider that they do not compromise participant safety or study assessments
- Participants who are taking prohibited medications as listed in Concomitant Drug/Therapy section within 14 days before dosing
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
California Clinical Trials Medical Group
Glendale, California, 91206
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2027 in Healthy Subjects
The purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of multiple ascending oral doses of E2027 in healthy participants.
- Conditions
- Healthy Subjects
- Being tested
- E2027, E2027 matched placebo
- Keywords
- E2027, Healthy participants, Pharmacokinetics, Pharmacodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E2027Drug
Participants will receive E2027 capsules, orally once daily (QD) on Days 1 to 14 after an overnight fast of at least 10 hours. E2027 will be administered orally with 240 milliliter (mL) (8 fluid ounces) of water.
E2027 matched placeboDrug
Participants will receive E2027 matched placebo capsules, orally once daily (QD) on Days 1 to 14 after an overnight fast of at least 10 hours. E2027 matched placebo will be administered orally with 240 mL (8 fluid ounces) of water.
| Study group | Role | What they receive |
|---|---|---|
| E2027 | Experimental | Four sequential cohorts of healthy participants (≥50 years and ≤85 years old) will be treated with multiple ascending doses of E2027 up to the maximum tolerated dose (MTD). A total of 6 participants per cohort will be randomized to E2027.Proposed doses of E2027 are:
* Part A Cohort 1: 50 mg (1 × 50 mg capsule)
* Cohort 2: 100 mg (2 × 50 mg capsules)
* Cohort 3: 200 mg (4 × 50 mg capsules)
* Cohort 4: 400 mg (8 × 50 mg capsules)
* Cohort 6: 25 mg (5 × 5 mg capsules) Part B
* Cohort 5: 400 mg (8 × 50 mg capsule)
Part C:
• Cohort 7: 50 mg (1 × 50 mg capsules)
Part D:
* Cohort 8: 5 mg (1 × 5 mg capsules)
* Cohort 9: 10 mg (2 × 5 mg capsules) Receives: Drug: E2027 |
| Placebo | Placebo comparator | Four sequential cohorts of healthy participants (≥50 years and ≤85 years old) will be treated with multiple ascending doses of E2027 matched placebo up to the MTD. A total of 2 participants per cohort will be randomized to E2027 matched placebo. Receives: Drug: E2027 matched placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum drug concentration (Cmax)
Blood samples will be collected on Day 1 at predose and postdose 0.5 (30 minutes), 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 18 hours; Day 14 (at predose and postdose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 18 hours); and Day 15 (24 hours postdose from Day 14).
Measured: Day 1 and Day 14
Mean predose drug concentration (Cmin)
Measured: Predose on Days 2, 4, 6, 8, 10, 12, 13, and 14
Mean time to reach maximum (peak) drug concentration (tmax)
Blood samples will be collected on Day 1 at predose and postdose 0.5 (30 minutes), 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18 and 24 hours; Day 14 (at predose and postdose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 18 hours); and Day 15 (24 hours postdose from Day 14).
Measured: Day 1 and Day 14
Mean area under the concentration-time curve from zero time to 24 hours postdose (AUC(0-24h))
Blood samples will be collected on Day 1 at predose and postdose 0.5 (30 minutes), 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18 and 24 hours; Day 14 (at predose and postdose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 18 hours); and Day 15 (24 hours postdose from Day 14).
Measured: Day 1 and Day 14
Mean area under the concentration-time curve from zero time extrapolated to infinity (AUC(0-inf))
Blood samples will be collected on Day 14 (at predose and postdose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 18 hours) and Day 15 (24 hours postdose from Day 14).
Measured: Day 14
Mean terminal elimination half-life (t1/2)
Blood samples will be collected on Day 14 (at predose and postdose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 18 hours) and Day 15 (24 hours postdose from Day 14).
Measured: Day 14
Average steady state drug concentration (Css,av)
Blood samples will be collected on Day 14 (at predose and postdose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 18 hours) and Day 15 (24 hours postdose from Day 14).
Measured: Day 14
Mean apparent clearance at steady state (CLss/F)
Blood samples will be collected on Day 14 (at predose and postdose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 18 hours) and Day 15 (24 hours postdose from Day 14).
Measured: Day 14
Mean apparent volume of distribution at steady state (Vss/F)
Blood samples will be collected on Day 14 (at predose and postdose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 18 hours) and Day 15 (24 hours postdose from Day 14).
Measured: Day 14
Mean accumulation ratio (Rac) (Day 14: Day 1) for AUC(0-24h), Cmax and Cmin
Day 1 at predose and postdose 0.5 (30 minutes), 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18 and 24 hours; Day 14 (at predose and postdose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 18 hours); and Day 15 (24 hours postdose from Day 14)
Measured: Day 1 and Day 14
Mean peak-trough fluctuation ratio (PTF)
Blood samples will be collected on Day 14 (at predose and postdose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 18 hours) and Day 15 (24 hours postdose from Day 14).
Measured: Day 14
Mean ratio of cerebrospinal fluid (CSF) : plasma concentrations
Measured: Day -2 (time-matched to the Day 13 lumbar puncture [LP]) and Day 13 (predose)
Secondary outcomes (2)
Percentage change from Baseline in pharmacodynamic measure
Measured: Day -2 (baseline with no drug) to Day 13 (on drug)
Change from baseline in Observed Fridericia's Correction Formula (QTcF)
Measured: Days -1, 1, and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study start10 Aug 2016
- Primary completion29 Nov 2017
- Study completion29 Nov 2017
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 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
- NCT02873156
- Sponsor's protocol ID
- E2027-A001-002
- Status last verified
- Nov 2017
- First submitted
- 16 Aug 2016
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2027 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02873156
- Acronym / sponsor ID
- E2027-A001-002
- Conditions
- Healthy Subjects
- Keywords
- E2027, Healthy participants, Pharmacokinetics, Pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Aug 2016 (actual)
- Primary completion
- 29 Nov 2017 (actual)
- Study completion
- 29 Nov 2017 (actual)
- First posted
- 19 Aug 2016 (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.
The purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of multiple ascending oral doses of E2027 in healthy participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E2027 | Experimental | Drug: E2027Four sequential cohorts of healthy participants (≥50 years and ≤85 years old) will be treated with multiple ascending doses of E2027 up to the maximum tolerated dose (MTD). A total of 6 participants per cohort will be randomized to E2027.Proposed doses of E2027 are: * Part A Cohort 1: 50 mg (1 × 50 mg capsule) * Cohort 2: 100 mg (2 × 50 mg capsules) * Cohort 3: 200 mg (4 × 50 mg capsules) * Cohort 4: 400 mg (8 × 50 mg capsules) * Cohort 6: 25 mg (5 × 5 mg capsules) Part B * Cohort 5: 400 mg (8 × 50 mg capsule) Part C: • Cohort 7: 50 mg (1 × 50 mg capsules) Part D: * Cohort 8: 5 mg (1 × 5 mg capsules) * Cohort 9: 10 mg (2 × 5 mg capsules) |
| Placebo | Placebo comparator | Drug: E2027 matched placeboFour sequential cohorts of healthy participants (≥50 years and ≤85 years old) will be treated with multiple ascending doses of E2027 matched placebo up to the MTD. A total of 2 participants per cohort will be randomized to E2027 matched placebo. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (38 listed)
- 1. Nonsmoking, male or female, age ≥50 years and ≤85 years old at the time of informed consent 2. Body mass index (BMI) ≥18 and ≤32 kilogram per square meter (kg/m2) at Screening Part B 3. Born in Japan to Japanese parents and grandparents of Japanese descent 4. Lifestyle, including diet, has not changed significantly since leaving Japan Exclusion Criteria
- 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 (documented by a negative beta-human chorionic gonadotropin [beta (ß)-hCG] (or human chorionic gonadotropin [hCG]) test with a minimum sensitivity of 25 International Unit per Liter (IU/L) or equivalent units of ß-hCG [or hCG]). A negative urine pregnancy test is required before the administration of the 1st dose per cohort.
- Females of childbearing potential who:
- Males who have not had a successful vasectomy (confirmed azoospermia) or they and their female partners do not meet the criteria above (ie, 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 28 days after study drug discontinuation
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| E2027Participants will receive E2027 capsules, orally once daily (QD) on Days 1 to 14 after an overnight fast of at least 10 hours. E2027 will be administered orally with 240 milliliter (mL) (8 fluid ounces) of water. | Drug | E2027 |
| E2027 matched placeboParticipants will receive E2027 matched placebo capsules, orally once daily (QD) on Days 1 to 14 after an overnight fast of at least 10 hours. E2027 matched placebo will be administered orally with 240 mL (8 fluid ounces) of water. | Drug | Placebo |
Primary outcome
Maximum drug concentration (Cmax)
Time frame: Day 1 and Day 14
Blood samples will be collected on Day 1 at predose and postdose 0.5 (30 minutes), 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 18 hours; Day 14 (at predose and postdose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 18 hours); and Day 15 (24 hours postdose from Day 14).
Mean predose drug concentration (Cmin)
Time frame: Predose on Days 2, 4, 6, 8, 10, 12, 13, and 14
Mean time to reach maximum (peak) drug concentration (tmax)
Time frame: Day 1 and Day 14
Blood samples will be collected on Day 1 at predose and postdose 0.5 (30 minutes), 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18 and 24 hours; Day 14 (at predose and postdose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 18 hours); and Day 15 (24 hours postdose from Day 14).
Mean area under the concentration-time curve from zero time to 24 hours postdose (AUC(0-24h))
Time frame: Day 1 and Day 14
Blood samples will be collected on Day 1 at predose and postdose 0.5 (30 minutes), 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18 and 24 hours; Day 14 (at predose and postdose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 18 hours); and Day 15 (24 hours postdose from Day 14).
Mean area under the concentration-time curve from zero time extrapolated to infinity (AUC(0-inf))
Time frame: Day 14
Blood samples will be collected on Day 14 (at predose and postdose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 18 hours) and Day 15 (24 hours postdose from Day 14).
Mean terminal elimination half-life (t1/2)
Time frame: Day 14
Blood samples will be collected on Day 14 (at predose and postdose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 18 hours) and Day 15 (24 hours postdose from Day 14).
Average steady state drug concentration (Css,av)
Time frame: Day 14
Blood samples will be collected on Day 14 (at predose and postdose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 18 hours) and Day 15 (24 hours postdose from Day 14).
Mean apparent clearance at steady state (CLss/F)
Time frame: Day 14
Blood samples will be collected on Day 14 (at predose and postdose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 18 hours) and Day 15 (24 hours postdose from Day 14).
Mean apparent volume of distribution at steady state (Vss/F)
Time frame: Day 14
Blood samples will be collected on Day 14 (at predose and postdose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 18 hours) and Day 15 (24 hours postdose from Day 14).
Mean accumulation ratio (Rac) (Day 14: Day 1) for AUC(0-24h), Cmax and Cmin
Time frame: Day 1 and Day 14
Day 1 at predose and postdose 0.5 (30 minutes), 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18 and 24 hours; Day 14 (at predose and postdose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 18 hours); and Day 15 (24 hours postdose from Day 14)
Mean peak-trough fluctuation ratio (PTF)
Time frame: Day 14
Blood samples will be collected on Day 14 (at predose and postdose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 18 hours) and Day 15 (24 hours postdose from Day 14).
Mean ratio of cerebrospinal fluid (CSF) : plasma concentrations
Time frame: Day -2 (time-matched to the Day 13 lumbar puncture [LP]) and Day 13 (predose)
2 secondary outcomes
Percentage change from Baseline in pharmacodynamic measure
Time frame: Day -2 (baseline with no drug) to Day 13 (on drug)
Change from baseline in Observed Fridericia's Correction Formula (QTcF)
Time frame: Days -1, 1, and 14
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 7 Sep 2018.
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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 E2027 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 38 inclusion and 0 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 7 Sep 2018. 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?
Maximum drug concentration (Cmax) (time frame: Day 1 and Day 14). The study lists 12 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 7 Sep 2018.