1. The main purpose of this study is to assess the safety and tolerability of AZD5213 after multiple oral doses. 2. Another purpose of this study is to evaluate the pharmacokinetics (also called PK - how the study drug enters and leaves your body and how your body acts on the study drug) of AZD5213 in your blood and urine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
73
oral solution, multiple ascending doses
Research Site
Overland Park, Kansas, United States
Adverse events, vital signs, physical (including neurological) examinations, clinical laboratory variables, electrocardiograms, telemetry, sleep diary (temporal and qualitative aspects), and the Columbia-Suicide Severity Rating Scale
Time frame: Up to 30 days screening period. Residential period will be 14 days. Follow up period will be 7 to 10 days after dose
Multiple-dose PK and dose proportionality
Time frame: Frequent timepoints within 48 hours of multiple dose day 1 and day 12.
Time to reach steady state
Time frame: Frequent timepoints within 48 hours of multiple dose day 1 and day 12.
Degree of accumulation and time dependancy of orally-administered AZD5213
Time frame: Frequent timepoints within 48 hours of multiple dose day 1 and day 12.
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