Healthy
Conditions
Keywords
Double-blind, randomized, placebo-controlled, parallel-group study, Safety, pharmacokinetics
Brief summary
To investigate the safety and tolerability of TC-5214 following oral administration of single and multiple ascending doses compared to placebo.
Interventions
DRUGTC-5214
4 mg tablet, oral, BID, group 1
DRUGPlacebo
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed