Evaluation of the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of E2609 in Healthy Subjects

Eisai

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: E2609

Study type: Interventional

Funder types: Industry

Identifiers

NCT01511783

E2609-A001-002

Details and patient eligibility

About

The purpose of this single-center, randomized, double-blind, placebo-controlled, study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of E2609 when administered to healthy elderly subjects.

Enrollment: 50 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Healthy males and females
• Female subjects must be of non-childbearing potential
• Aged 50 to 85 years, inclusive BMI of 18 to 32 kg/m2 at screening
• Thyroid function tests within normal rangeMini-Mental State Examination score of 28-30, inclusive

Key Exclusion Criteria:

• History of neurological abnormalities, including seizures
• Any clinically significant abnormality of the ECG at Screening and Baseline including QTc prolongation
• History of ischemic heart disease, cardiac arrhythmias, cerebrovascular diseases
• Other medical conditions that are not stably controlled
• Presence of orthostatic hypotension

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

E2609

Experimental group

Description:

E2609 at ascending doses

Treatment:

Drug: E2609

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo