Pharmacokinetics and Pharmacodynamics of Sertraline After Low Dose Administration

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

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.

Intervention(s) in this Clinical Trial

• Drug: Sertraline
  • Multiple doses of 5, 25, and 50 mg Sertraline for 6 days each period.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Sertraline
  • Single Arm

Primary Measures

• Serotonin receptor occupancy
  • Time Frame: Day -1, Day 7, Day 14, Day 21
    Safety Issue?: No

Secondary Measures

• Plasma concentration of sertraline
  • Time Frame: Day 4, 5, 6, 7, 11, 12, 13, 14, 18, 19, 20, 21
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 50 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Seoul National University Hospital Other

Overall Clinical Trial Officials and Contacts

Kyung-Sang Yu, MD, PhD Principal Investigator Seoul National University College of Medicine and Hospital  

Information obtained from ClinicalTrials.gov on February 02, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00969852

Study ID Number: SNUCPT09_Sertraline

ClinicalTrials.gov Identifier: NCT00969852

Health Authority: South Korea: Institutional Review Board