Study to Evaluate the Safety and Tolerability of a Once Daily Dose of 50 mg E2609 in Healthy Japanese Subjects

NCT03055962 | Completed Phase 1

• 1 other identifier: E2609-J081-014
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Participants

Keywords

Healthy Participants; E2609; Pharmacokinetics; Japan

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  up to Day 62

Secondary Outcomes (9)

• Mean maximum observed concentration (Cmax) of E2609 and metabolites on Day 1 and Day 14

  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

  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

  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

  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

  Day 14: 1, 2, 3, 4, 6, 10, 24, 48, 72, 96, and 144 hours postdose

Study Arms (2)

E2609 50 mg

EXPERIMENTAL

Participants will receive E2609 50 milligrams (mg) orally once a day for 14 days.

Drug: E2609

Placebo

PLACEBO COMPARATOR

Participants will receive matching placebo orally once a day for 14 days.

Drug: Placebo

Interventions

E2609 DRUG

tablet

E2609 50 mg

Placebo DRUG

tablet

Placebo

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eisai Co., Ltd.: lead

Study Sites (1)

Eisai Trial Site

Fukuoka, Fukuoka, Japan

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2017
• First Posted: February 16, 2017
• Study Start: February 14, 2017
• Primary Completion: March 29, 2017
• Study Completion: April 11, 2017
• Last Updated: April 18, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)