Evaluation of the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of E2609 in Healthy Subjects
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 50 - 85 |
| Updated: | 4/21/2016 |
| Start Date: | December 2011 |
| End Date: | November 2012 |
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.
evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of E2609 when
administered to healthy elderly subjects.
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
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