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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: TC-5214; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01145768

D4130C00006

Details and patient eligibility

About

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

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Each cohort will have 9 volunteers that will receive TC-5214

Treatment:

Drug: TC-5214

Drug: TC-5214

2

Placebo Comparator group

Description:

Each cohort will have 3 volunteers that will receive placebo

Treatment:

Drug: Placebo