A Study of Single and Multiple Ascending Doses of TC-5214 in Japanese Healthy Elderly Male and Female Volunteers

A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of TC-5214 in Japanese Healthy Elderly Male and Female Volunteers

The purpose of this study is to assess safety, tolerability and pharmacokinetics of TC-5214 in elderly healthy Japanese volunteers.

Inclusion Criteria:

• Japanese healthy elderly male and female ≥65 years old.
• Have a BMI of ≥18 and ≤27 kg/m2 and weigh ≥ 45 kg.
• Be able to understand and comply with the requirements of the study as judged by the investigator(s).

Exclusion Criteria:

• History of any clinically significant medical or neurologic disease or disorder.
• History of gastrointestinal surgery or unintentional rapid weight loss.
• Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the study drug.