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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

January 13, 2012
February 6, 2013
December 2011
July 2012   (final data collection date for primary outcome measure)
Incidence of adverse events [ Time Frame: 19 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01511783 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Evaluation of the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of E2609 in Healthy Subjects
A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics 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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Healthy
  • 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.
  • 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.
  • Experimental: E2609
    E2609 at ascending doses
    Intervention: Drug: E2609
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
November 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
50 Years to 85 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01511783
E2609-A001-002
Not Provided
Eisai Inc.
Eisai Inc.
Not Provided
Principal Investigator: Craig Curtis Compass Research Phase 1, LLC
Eisai Inc.
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP