Pharmacokinetics and Pharmacodynamics of Sertraline After Low Dose Administration
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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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | [11C] Sertraline PET Imaging Study That Investigates Pharmacokinetics and Pharmacodynamics of Sertraline After Low Dose Administration |
- Serotonin receptor occupancy [ Time Frame: Day -1, Day 7, Day 14, Day 21 ] [ Designated as safety issue: No ]
- Plasma concentration of sertraline [ Time Frame: Day 4, 5, 6, 7, 11, 12, 13, 14, 18, 19, 20, 21 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 10 |
| Study Start Date: | July 2009 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Sertraline
Single Arm
|
Drug: Sertraline
Multiple doses of 5, 25, and 50 mg Sertraline for 6 days each period.
Other Name: Zoloft(Pfizer)
|
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| Ages Eligible for Study: | 20 Years to 50 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Korea, Republic of | |
| Clinical Trials Center, Seoul National University Hospital | |
| Seoul, Korea, Republic of, 110-744 | |
| Principal Investigator: | Kyung-Sang Yu, MD, PhD | Seoul National University College of Medicine and Hospital |
More Information
No publications provided by Seoul National University Hospital
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Kyung-Sang Yu/Professor, Seoul National University Hospital |
| ClinicalTrials.gov Identifier: | NCT00969852 History of Changes |
| Other Study ID Numbers: | SNUCPT09_Sertraline |
| Study First Received: | August 29, 2009 |
| Last Updated: | January 9, 2011 |
| Health Authority: | South Korea: Institutional Review Board |
Keywords provided by Seoul National University Hospital:
|
Sertraline PET Serotonin receptor occupancy PK-PD Model |
Additional relevant MeSH terms:
|
Sertraline Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 22, 2013