Evaluation of the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of E2609 in Healthy Subjects - Full Text View

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.

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 May 19, 2013