Evaluation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2609 in Healthy Subjects and an Elderly Cohort
Phase 1
Completed
- Conditions
- Alzheimer's Disease
- Interventions
- Drug: Placebo
- Registration Number
- NCT01294540
- Lead Sponsor
- Eisai Inc.
- Brief Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of E2609 when administered as single doses to healthy adult volunteers and healthy elderly subjects. The study will consist of 2 parts:(1) a single dose in healthy adult volunteers, at doses up to 800 mg or the maximum dose that can be tolerated, (2) a single dose of 50 mg in healthy elderly volunteers.
- Detailed Description
The study will consist of 2 parts: (1) a single dose in healthy adult volunteers, at doses up to 100 mg or the maximum dose that can be tolerated, (2) a single dose of 25 mg or lower in healthy elderly volunteers.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 73
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Placebo Comparator: 2 Placebo -
- Primary Outcome Measures
Name Time Method Safety and tolerability as evidenced by the number of subjects with adverse events 38 days
- Secondary Outcome Measures
Name Time Method To assess the pharmacokinetics (PK) of E2609 in plasma and urine following administration of single oral doses 4 days
Trial Locations
- Locations (1)
Glendale Adventist Medical Center
🇺🇸Glendale, California, United States