This study aimed to explore the pharmacokinetics and pharmacodynamics of low dose sertraline with \[11C\] sertraline positron emission tomography (PET) study.
Open, one arm, single sequence, 3-period, dose escalating study for healthy volunteers are investigated. Ten subjects may be enrolled. Subjects receive baseline \[11C\] sertraline PET. Period 1 Subjects receive 5 mg of sertraline every day. After 6 day of medication, pharmacokinetic and PET studies are performed. Period 2 Subjects receive 25 mg of sertraline every day. After 6 day of medication, pharmacokinetic and PET studies are performed. Period 3 Subjects receive 50 mg of sertraline every day. After 6 day of medication, pharmacokinetic and PET studies are performed.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Multiple doses of 5, 25, and 50 mg Sertraline for 6 days each period.
Clinical Trials Center, Seoul National University Hospital
Seoul, South Korea
Serotonin receptor occupancy
Time frame: Day -1, Day 7, Day 14, Day 21
Plasma concentration of sertraline
Time frame: Day 4, 5, 6, 7, 11, 12, 13, 14, 18, 19, 20, 21
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