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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01511783
First received: January 13, 2012
Last updated: February 6, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: E2609
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of E2609 in Healthy Subjects

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Incidence of adverse events [ Time Frame: 19 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Plasma Cmax and AUC (0-24h) of E2609 on Day 1 and Day 14 [ Time Frame: 20 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Time at which Amax occurs for plasma Aβ(1-x) [ Time Frame: 20 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Percent change of Aβ(1-x) in CSF from Day -2 to Day 14 [ Time Frame: 20 days ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: December 2011
Study Completion Date: November 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: E2609
E2609 at ascending doses
Drug: E2609
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 Comparator: Placebo Drug: Placebo
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.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01511783

Locations
United States, Florida
Compass Research Phase 1, LLC
Orlando, Florida, United States, 32806
Sponsors and Collaborators
Eisai Inc.
Investigators
Principal Investigator: Craig Curtis Compass Research Phase 1, LLC
  More Information

No publications provided

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01511783     History of Changes
Other Study ID Numbers: E2609-A001-002
Study First Received: January 13, 2012
Last Updated: February 6, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 15, 2014