Status:
COMPLETED
Evaluation of the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of E2609 in Healthy Subjects
Lead Sponsor:
Eisai Inc.
Conditions:
Healthy
Eligibility:
All Genders
50-85 years
Phase:
PHASE1
Brief Summary
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 hea...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01511783
Start Date
December 1 2011
End Date
November 1 2012
Last Update
November 3 2015
Active Locations (1)
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1
Compass Research Phase 1, LLC
Orlando, Florida, United States, 32806