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

Status

Unknown

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223449

Enrollment

Registered

2017-02-01

Start date

2017-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Japanese Subject

Interventions

investigational material(s) Generic name etc : E2609 INN of investigational material : Therapeutic category code : 119 Other agents affecting central nervous system Dosage and Administration for Inve

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Healthy males and females (2)Aged 50 to 85 years, inclusive at time of consent (3)Body mass index (BMI) of 17.6 to 32 kilograms per meters squared (kg/m2) at Screening

Exclusion criteria

Exclusion criteria: (1)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) (2)A history of cerebrovascular accident or non-vasovagal-related loss of consciousness (3)Any clinically significant findings on neurological examination (4)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 (5)A history of cardiac arrhythmias, ischemic heart disease, or cerebrovascular disease (6)A history of gastrointestinal surgery that may affect the pharmacokinetic profile of E2609 (eg, hepatectomy, nephrotomy, digestive organ resection) (7)A known history of clinically significant drug or food allergies or presently experiencing significant seasonal allergy

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026