Pharmacokinetics and Pharmacodynamics of Sertraline After Low Dose Administration

Study Overview
=================
Brief Summary
-----------------
This study aimed to explore the pharmacokinetics and pharmacodynamics of low dose sertraline with [11C] sertraline positron emission tomography (PET) study.

Detailed Description
-----------------
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.

Official Title
-----------------
[11C] Sertraline PET Imaging Study That Investigates Pharmacokinetics and Pharmacodynamics of Sertraline After Low Dose Administration

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Sertraline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: Between 20 to 50 years of age, inclusive (age based on the date to give the informed consent) Weight: Over 55 kg, within ±20% of ideal body weight Subject who are reliable and willing to make themselves available during the study period, are willing to follow the study protocol, and give their written informed consent voluntarily Exclusion Criteria: History of significant clinical illness needs medical caution, including cardiovascular, immunologic, hematologic, neuropsychiatric, respiratory, gastrointestinal, hepatic, or renal disease or other chronic disease History of a significant surgical resection of gastrointestinal tract except appendectomy Abnormal clinical laboratory findings, especially for AST or ALT > 1.25 fold of upper normal limit Subject who has phobia for PET scan History or evidence of drug abuse Use any prescriptive medication, Korean traditional medication not considered acceptable by the clinical investigator during the last 14 days period before first dosing, or use any OTC medication not considered acceptable by the clinical investigator during the last 7 days period before first dosing (If used medication is considered acceptable by investigator, patients can be included) Participation in clinical trials of any drug within 2 months prior to the participation of the study Donation of whole blood within 2 months or a unit of blood within 1 month prior to the start of study Judged to be inappropriate for the study by the investigator

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sertraline<br>Single Arm | Drug: Sertraline<br>* Multiple doses of 5, 25, and 50 mg Sertraline for 6 days each period.<br>* Other names: Zoloft(Pfizer);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serotonin receptor occupancy |  | Day -1, Day 7, Day 14, Day 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentration of sertraline |  | Day 4, 5, 6, 7, 11, 12, 13, 14, 18, 19, 20, 21 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sertraline, PET, Serotonin receptor occupancy, PK-PD Model