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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03055962
• Date of registration: 10/02/2017
• Prospective Registration: Yes
• Primary sponsor: Eisai Co., Ltd.
• Public title: Study to Evaluate the Safety and Tolerability of a Once Daily Dose of 50 mg E2609 in Healthy Japanese Subjects
• Scientific 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
• Date of first enrolment: February 14, 2017
• Target sample size: 16
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03055962
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

Japan

Key inclusion & exclusion 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



Age minimum: 50 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Healthy Participants

Intervention(s)

Drug: Placebo

Drug: E2609

Primary Outcome(s)

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)]

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)]

Number of participants with an abnormal, clinically significant vital sign value [Time Frame: Screening; Baseline; up to Day 62]

Mean quality of sleep score per the Waketime Questionnaire, if necessary [Time Frame: up to Day 62]

Number of participants with an abnormal, clinically significant electrocardiogram (ECG) finding [Time Frame: Screening; Baseline; up to Day 62]

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)]

Secondary Outcome(s)

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 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]

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]

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]

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 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]

Number of participants with polymorphisms of N-acetyltransferase 2 (NAT2) [Time Frame: Day 1]

Secondary ID(s)

E2609-J081-014

Source(s) of Monetary Support

Please refer to primary and secondary sponsors