A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of E2609 in Healthy Subjects

Eisai Inc.1 site in 1 country50 target enrollmentDecember 2011

ConditionsHealthy

InterventionsE2609 Placebo

DrugsE2609 Placebo

Overview

Phase: Phase 1
Intervention: E2609
Conditions: Healthy
Sponsor: Eisai Inc.
Enrollment: 50
Locations: 1
Primary Endpoint: Incidence of adverse events
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

December 2011

End Date

November 2012

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eisai Inc.

Responsible Party

Sponsor

Eligibility Criteria

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

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

Arms & Interventions

E2609

E2609 at ascending doses

Intervention: E2609

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Incidence of adverse events

Time Frame: 19 days

Secondary Outcomes

Plasma Cmax and AUC (0-24h) of E2609 on Day 1 and Day 14(20 days)
Plasma Aβ(1-x) Amax (defined as maximum change (%) of E2609 levels compared to time-matched baseline at a single time point within 24 hours postdose) in plasma and cerebrospinal fluid, plasma and CSF(20 days)
Time at which Amax occurs for plasma Aβ(1-x)(20 days)
Area under the plasma Aβ(1-x) concentration, AUAC(0-24h), by time curve from time 0 to time 24 hours on Day -1, Day 1, and Day 14(20 days)
Change (%) in plasma Aβ(1-x) AUAC within 24 hours comparing Day 1 to Day -1 and Day 14 to Day -1(20 days)
Percent change of Aβ(1-x) in CSF from Day -2 to Day 14(20 days)