Clinical trial NCT00969852: Pharmacokinetics and Pharmacodynamics of Sertraline After Low Dose Administration
Official title: [11C] Sertraline PET Imaging Study That Investigates Pharmacokinetics and Pharmacodynamics of Sertraline After Low Dose Administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: Sertraline
PET
Serotonin receptor occupancy
PK-PD Model
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Welfare and Family Affairs
name: Korea National Enterprise for Clinical Trials
First posted: 2009-09-01
Enrollment: 10
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Serotonin receptor occupancy
timeFrame: Day -1, Day 7, Day 14, Day 21
Secondary outcomes:
measure: Plasma concentration of sertraline
timeFrame: Day 4, 5, 6, 7, 11, 12, 13, 14, 18, 19, 20, 21
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Clinical Trials Center, Seoul National University Hospital
Study officials:
affiliation: Seoul National University College of Medicine and Hospital
name: Kyung-Sang Yu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.