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

NCT01511783 | Completed Phase 1

• 1 other identifier: E2609-A001-002
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  19 days

Secondary Outcomes (6)

• 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

Study Arms (2)

E2609

EXPERIMENTAL

E2609 at ascending doses

Drug: E2609

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

E2609 DRUG

E2609 to be administered for 14 days, concurrently with placebo controls. Doses will be 25, 50, and 200 mg once daily by the oral route, each dose administered to a separate cohort (group) of subjects. After each dose has been administered to all subjects in a given cohort, safety and tolerability findings will be evaluated and a decision made by the sponsor and investigators as to whether or not to proceed to the next higher dose.

E2609

Placebo DRUG

E2609 to be administered for 14 days, concurrently with placebo controls. Doses will be 25, 50, and 200 mg once daily by the oral route, each dose administered to a separate cohort (group) of subjects. After each dose has been administered to all subjects in a given cohort, safety and tolerability findings will be evaluated and a decision made by the sponsor and investigators as to whether or not to proceed to the next higher dose.

Placebo

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (1)

Compass Research Phase 1, LLC

Orlando, Florida, 32806, United States

Location

Study Officials

• Craig Curtis

  Compass Research Phase 1, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2012
• First Posted: January 19, 2012
• Study Start: December 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: November 1, 2012
• Last Updated: November 3, 2015

Record last verified: 2015-11

Locations

US (1)