Pharmacokinetics and Pharmacodynamics of Sertraline After Low Dose Administration

January 9, 2011 updated by: Seoul National University Hospital

[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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Clinical trials center, Seoul national university hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sertraline
Single Arm
Drug: Sertraline
Multiple doses of 5, 25, and 50 mg Sertraline for 6 days each period.
Other Names:
  • Zoloft(Pfizer)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Ministry of Health, Welfare and Family Affairs
Korea National Enterprise for Clinical Trials

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

August 29, 2009

First Submitted That Met QC Criteria

August 31, 2009

First Posted (Estimate)

September 1, 2009

Study Record Updates

Last Update Posted (Estimate)

January 11, 2011

Last Update Submitted That Met QC Criteria

January 9, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUCPT09_Sertraline

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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