Pharmacokinetics and Pharmacodynamics of Sertraline After... | NCT00969852

Studies
Pharmacokinetics and Pharmacodynamics of Sertraline After Low Dose Administration

NCT00969852

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Jan 11, 2011Estimated

Enrollment

10Estimated

Phase

Phase 4

Conditions

Healthy

Interventions

Sertraline

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2009

Primary Completion Date

Aug 2009Actual

Completion Date

Mar 2010Actual

First Submitted Date

Aug 29, 2009

First Submission Date that Met QC Criteria

Aug 31, 2009

First Posted Date

Sep 1, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 9, 2011

Last Update Posted Date

Jan 11, 2011Estimated

Name	Class
Ministry of Health, Welfare and Family Affairs	UNKNOWN
Korea National Enterprise for Clinical Trials	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Label	Type	Description	Intervention Names
Sertraline	Experimental	Single Arm	Drug: Sertraline

Name	Type	Description	Arm Group Labels	Other Names
Sertraline	Drug	Multiple doses of 5, 25, and 50 mg Sertraline for 6 days each period.	Sertraline

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

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

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Kyung-Sang Yu, MD, PhD	Seoul National University College of Medicine and Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Trials Center, Seoul National University Hospital		Seoul		110-744	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22373835	Derived	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.

ID	Term
D015057	1-Naphthylamine
D000588	Amines
D009930	Organic Chemicals
D009281	Naphthalenes