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| Sponsor: | Seoul National University Hospital |
|---|---|
| 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 |
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 IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacokinetics/Dynamics Study |
| Official Title: | [11C] Sertraline PET Imaging Study That Investigates Pharmacokinetics and Pharmacodynamics of Sertraline After Low Dose Administration |
| Estimated Enrollment: | 10 |
| Study Start Date: | July 2009 |
| Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Sertraline: Experimental
Single Arm
|
Drug: Sertraline
Multiple doses of 5, 25, and 50 mg Sertraline for 6 days each period.
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Kyung-Sang Yu, MD, PhD | +82-2072-1920 | ksyu@snu.ac.kr |
| Contact: Kwang-Hee Shin | +82-2-2072-1930 | happyi69@snu.ac.kr |
| Korea, Republic of | |
| Clinical Trials Center, Seoul National University Hospital | Recruiting |
| Seoul, Korea, Republic of, 110-744 | |
| Contact: Kyung-Sang Yu, PhD 82-2-2072-1920 ksyu@snu.ac.kr | |
| Sub-Investigator: In-Jin Jang, MD, PhD | |
| Sub-Investigator: Jae-Min Jung, PhD | |
| Sub-Investigator: Jae Sung Lee, PhD | |
| Sub-Investigator: Won-Sik Ahn, MD, PhD | |
| Principal Investigator: | Kyung-Sang Yu, MD, PhD | Seoul National University College of Medicine and Hospital |
More Information
| Responsible Party: | Seoul National University Hospital ( Kyung-Sang Yu/Professor ) |
| Study ID Numbers: | SNUCPT09_Sertraline |
| Study First Received: | August 29, 2009 |
| Last Updated: | August 31, 2009 |
| ClinicalTrials.gov Identifier: | NCT00969852 History of Changes |
| Health Authority: | South Korea: Institutional Review Board |
|
Sertraline PET Serotonin receptor occupancy PK-PD Model |
|
Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Serotonin Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs |
Psychotropic Drugs Sertraline Serotonin Uptake Inhibitors Central Nervous System Agents Pharmacologic Actions Antidepressive Agents |