Status:
COMPLETED
To Investigate the Safety and Tolerability of TC-5214 Following Oral Administration of Multiple Doses for up to 8 Days
Lead Sponsor:
AstraZeneca
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
To investigate the safety and tolerability of TC-5214 following oral administration of single and multiple ascending doses compared to placebo.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2010
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT01145768
Start Date
June 1 2010
End Date
August 1 2010
Last Update
December 8 2010
Active Locations (1)
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1
Research Site
Overland Park, Kansas, United States