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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 November 25, 2014