Pharmacokinetics and Pharmacodynamics of Sertraline After Low Dose Administration

NCT00969852 | Completed Phase 4

• 1 other identifier: SNUCPT09_Sertraline
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Sertraline; PET; Serotonin receptor occupancy; PK-PD Model

Outcome Measures

Primary Outcomes (1)

• Serotonin receptor occupancy

  Day -1, Day 7, Day 14, Day 21

Secondary Outcomes (1)

• Plasma concentration of sertraline

  Day 4, 5, 6, 7, 11, 12, 13, 14, 18, 19, 20, 21

Study Arms (1)

Sertraline

EXPERIMENTAL

Single Arm

Drug: Sertraline

Interventions

Sertraline DRUG

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

Also known as: Zoloft(Pfizer)

Sertraline

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Ministry of Health, Welfare and Family Affairs: collaborator
• Korea National Enterprise for Clinical Trials: collaborator

Study Sites (1)

Clinical Trials Center, Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (1)

• Shin KH, Kim KP, Lim KS, Kim JW, Lee YS, Yang BY, Lee JS, Jung JM, Yoon SH, Jang IJ, Yu KS. A positron emission tomography microdosing study with sertraline in healthy volunteers. Int J Clin Pharmacol Ther. 2012 Mar;50(3):224-32. doi: 10.5414/cp201644.

  PMID: 22373835 DERIVED

MeSH Terms

Interventions

Sertraline

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Kyung-Sang Yu, MD, PhD

  Seoul National University College of Medicine and Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 29, 2009
• First Posted: September 1, 2009
• Study Start: July 1, 2009
• Primary Completion: August 1, 2009
• Study Completion: March 1, 2010
• Last Updated: January 11, 2011

Record last verified: 2011-01

Locations

KR (1)