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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

To investigate the safety and tolerability of TC-5214 following oral administration of single and multiple ascending doses compared to placebo.

Key facts

Study ID

NCT01145768

Run by

AstraZeneca

People needed

72

Starts

2010-06-01

Expected to finish

2010-08-01

Last updated by the study team

2010-12-08

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — Overland Park, Kansas, United States

Full record on ClinicalTrials.gov

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