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Completed

NCT Number: NCT01511783

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

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.

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Key information

Conditions

Healthy

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Compass Research Phase 1, LLC

Orlando, Florida, 32806, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Incidence of adverse events

    Time frame: 19 days

Secondary outcomes

  1. Plasma Cmax and AUC (0-24h) of E2609 on Day 1 and Day 14

    Time frame: 20 days

  2. 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

    Time frame: 20 days

  3. Time at which Amax occurs for plasma Aβ(1-x)

    Time frame: 20 days

  4. 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

    Time frame: 20 days

  5. Change (%) in plasma Aβ(1-x) AUAC within 24 hours comparing Day 1 to Day -1 and Day 14 to Day -1

    Time frame: 20 days

  6. Percent change of Aβ(1-x) in CSF from Day -2 to Day 14

    Time frame: 20 days

Sponsors and collaborators

Lead sponsor

Eisai Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 19, 2012
Registry last updated
Nov 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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