Clinical trial NCT03055962: Study to Evaluate the Safety and Tolerability of a Once Daily Dose of 50 mg E2609 in Healthy Japanese Subjects
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: Healthy Participants
E2609
Pharmacokinetics
Japan
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2017-02-16
Enrollment: 16
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of participants with any serious adverse event and number of participants with any non-serious adverse event
timeFrame: up to Day 35 (Termination/Visit 5)
measure: Number of participants with an abnormal, clinically significant laboratory test value
timeFrame: 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)
measure: Number of participants with an abnormal, clinically significant vital sign value
timeFrame: Screening; Baseline; up to Day 62
measure: Number of participants with an abnormal, clinically significant electrocardiogram (ECG) finding
timeFrame: Screening; Baseline; up to Day 62
measure: Clinical assessment of suicidality per the suicidality rating scale
timeFrame: 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)
measure: Mean quality of sleep score per the Waketime Questionnaire, if necessary
timeFrame: up to Day 62
Secondary outcomes:
measure: Mean maximum observed concentration (Cmax) of E2609 and metabolites on Day 1 and Day 14
timeFrame: Days 1 and 14: predose; 1, 2, 3, 4, 6, and 10 hours postdose
measure: Mean minimum observed concentration (Cmin) of E2609 and metabolites on Day 1 and Day 14
timeFrame: Days 1 and 14: predose; 1, 2, 3, 4, 6, and 10 hours postdose
measure: Median time from dosing to reach Cmax (tmax) of E2609 and metabolites on Day 1 and Day 14
timeFrame: Days 1 and 14: predose; 1, 2, 3, 4, 6, and 10 hours postdose
measure: Mean area under the concentration-time curve (AUC) from time 0 to 24 hours for E2609 and metabolites on Day 1 and Day 14
timeFrame: Days 1 and 14: 1, 2, 3, 4, 6, 10, and 24 hours postdose
measure: Mean terminal elimination half-life (t1/2) following the last day of dosing (Day 14) of E2609 and metabolites
timeFrame: Day 14: 1, 2, 3, 4, 6, 10, 24, 48, 72, 96, and 144 hours postdose
measure: 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
timeFrame: Days 1 and 14: 1, 2, 3, 4, 6, 10, and 24 hours postdose
measure: Mean accumulation ratio for AUC, Cmax, and Cmin (Rac) for E2609 and metabolites on Day 1 and Day 14
timeFrame: Days 1 and 14: 1, 2, 3, 4, 6, 10, and 24 hours postdose
measure: Apparent clearance at steady state (CLss/F) of E2609 on Day 14
timeFrame: Day 14: 1, 2, 3, 4, 6, 10, 24, 48, 72, 96, and 144 hours postdose
measure: Number of participants with polymorphisms of N-acetyltransferase 2 (NAT2)
timeFrame: Day 1
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: Eisai Trial Site
Study officials:
References: