Pharmacokinetics and Pharmacodynamics of Sertraline After Low Dose Administration

NCT ID: NCT00969852

Last Updated: 2011-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2010-03-31

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.

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sertraline

Single Arm

Group Type: EXPERIMENTAL

Sertraline

Intervention Type: DRUG

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

Interventions

Sertraline

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

Intervention Type: DRUG

Other Intervention Names

Zoloft(Pfizer)

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ministry of Health, Welfare and Family Affairs

UNKNOWN

Sponsor Role: collaborator

Korea National Enterprise for Clinical Trials

OTHER

Sponsor Role: collaborator

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Seoul National University Hospital

Principal Investigators

Kyung-Sang Yu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University College of Medicine and Hospital

Locations

Clinical Trials Center, Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 22373835 (View on PubMed)

Other Identifiers

SNUCPT09_Sertraline

Identifier Type: -

Identifier Source: org_study_id