Pharmacokinetics and Pharmacodynamics of Sertraline After Low Dose Administration

Phase 4

Completed

• Conditions: Healthy
• Interventions: Drug: Sertraline

• Registration Number: NCT00969852
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study Start: 2009-07
• Primary Completion: 2009-08
• Study First Submitted: 2009-08-29
• Study First Submitted QC: 2009-08-31
• Study First Posted: 2009-09-01
• Study Completion: 2010-03
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-09
• Last Update Posted: 2011-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sertraline	Sertraline	Single Arm

Primary Outcome Measures

Name	Time	Method
Serotonin receptor occupancy	Day -1, Day 7, Day 14, Day 21

Secondary Outcome Measures

Name	Time	Method
Plasma concentration of sertraline	Day 4, 5, 6, 7, 11, 12, 13, 14, 18, 19, 20, 21

Trial Locations

Locations (1)

Clinical Trials Center, Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of