Evaluation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2609 in Healthy Subjects and an Elderly Cohort
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion:
- Healthy males and females
- Aged 30 to 55 years, inclusive (Cohorts 1 through 5); aged 65 to 85 years, inclusive (Cohort 6)
- Body mass index (BMI) of 18 to 32kg/m^2 at Screening
- Additional inclusion criteria for Cohort 6 (healthy elderly subjects)
Exclusion
- Females of child-bearing potential
- Personal or family history of neurological abnormalities
- Any clinical abnormality of the electrocardiogram (ECG)at Screening and check-in
- A family history of cardiac abnormalities
- Thyroid abnormalities
Trial design
Primary purpose
Allocation
Interventional model
Masking
73 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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