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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: E2609; Drug: Placebo

• Registration Number: NCT01511783
• Lead Sponsor: Eisai Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-01-13
• Study First Submitted QC: 2012-01-18
• Study First Posted: 2012-01-19
• Primary Completion: 2012-07
• Study Completion: 2012-11
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-02
• Last Update Posted: 2015-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
E2609	E2609	E2609 at ascending doses
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events	19 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Compass Research Phase 1, LLC; 🇺🇸 Orlando, Florida, United States