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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: TC-5214; Drug: Placebo

• Registration Number: NCT01145768
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-07
• Study First Submitted QC: 2010-06-15
• Study First Posted: 2010-06-17
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-06
• Last Update Posted: 2010-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	TC-5214	Each cohort will have 9 volunteers that will receive TC-5214
2	Placebo	Each cohort will have 3 volunteers that will receive placebo

Primary Outcome Measures

Name	Time	Method
safety and tolerability assessed by incidence and severity of AE's, abnormalities in vital sign assessments, ECG's, telemetry, clinical lab assessments, physical exams, neurological exams, suicidality evaluations, visual acuity tests and digital ECGs	Collected prior to treatment, during treatment and for 7-10 days following discharge. Volunteers will be monitored througout the study for adverse events.

Secondary Outcome Measures

Name	Time	Method
To characterize the pharmacokinetics of TC-5214 in blood and urine after single and repeated oral doses by collecting blood and urine samples to measure drug concentration levels	Blood sampling, every in house day; urine collection ;Days -1 through Day 6, Days 8 through 11.
To assess the effect of food on the pharmacokinetics of TC-5214 following oral administration by collecting blood and urine samples to measure drug concentration levels.	Samples taken during the residential period at defined timepoints pre-dose and post-dose

Trial Locations

Locations (1)

Research Site; 🇺🇸 Overland Park, Kansas, United States