Pharmacokinetics and Pharmacodynamics of Sertraline After Low Dose Administration

This study has been completed.
Sponsor:
Collaborators:
Ministry of Health, Welfare and Family Affairs
Korea National Enterprise for Clinical Trials
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00969852
First received: August 29, 2009
Last updated: January 9, 2011
Last verified: January 2011
  Purpose

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


Condition Intervention Phase
Healthy
Drug: Sertraline
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: [11C] Sertraline PET Imaging Study That Investigates Pharmacokinetics and Pharmacodynamics of Sertraline After Low Dose Administration

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Serotonin receptor occupancy [ Time Frame: Day -1, Day 7, Day 14, Day 21 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma concentration of sertraline [ Time Frame: Day 4, 5, 6, 7, 11, 12, 13, 14, 18, 19, 20, 21 ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: July 2009
Study Completion Date: March 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sertraline
Single Arm
Drug: Sertraline
Multiple doses of 5, 25, and 50 mg Sertraline for 6 days each period.
Other Name: Zoloft(Pfizer)

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.

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00969852

Locations
Korea, Republic of
Clinical Trials Center, Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
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
  More Information

No publications provided by Seoul National University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kyung-Sang Yu/Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00969852     History of Changes
Other Study ID Numbers: SNUCPT09_Sertraline
Study First Received: August 29, 2009
Last Updated: January 9, 2011
Health Authority: South Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
Sertraline
PET
Serotonin receptor occupancy
PK-PD Model

Additional relevant MeSH terms:
Sertraline
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 23, 2014