Overview

To Investigate the Safety and Tolerability of TC-5214 Following Oral Administration of Multiple Doses for up to 8 Days

Status:
Completed
Trial end date:
2010-08-01
Target enrollment:
0
Participant gender:
All
Summary
To investigate the safety and tolerability of TC-5214 following oral administration of single and multiple ascending doses compared to placebo.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
AstraZeneca
Criteria
Inclusion Criteria:

- Male and nonpregnant, nonlactating female, with suitable veins for cannulation or
repeated venipuncture

- Contraceptive use from the first dose of investigational product until12 weeks after
their last dose

- Body mass index (BMI) between 19 and 32 kg/m2 and weigh at least 50 kg

Exclusion Criteria:

- History of any clinically significant medical, neurologic or psychiatric disease or
disorder which, in the opinion of the Investigator and Sponsor, may either put the
volunteer at risk because of participation in the study, or influence the results of

- History of gastrointestinal surgery (except for cholecystectomy and appendectomy) or
unintentional rapid weight loss

- Volunteers with a history of suicide attempts in the past year and/or seen by the
Investigator as having a significant history of risk of suicide or homicide, or
considered at risk for suicide or homicide during the study