Pharmacokinetics and Pharmacodynamics of Sertraline After Low Dose Administration
Information source: Seoul National University Hospital
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Sertraline (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Seoul National University Hospital Official(s) and/or principal investigator(s):
Kyung-Sang Yu, MD, PhD, Principal Investigator, Affiliation: Seoul National University College of Medicine and Hospital
Overall contact:
Kyung-Sang Yu, MD, PhD, Phone: +82-2072-1920, Email: ksyu@snu.ac.kr
Summary
This study aimed to explore the pharmacokinetics and pharmacodynamics of low dose sertraline
with [11C] sertraline positron emission tomography (PET) study.
Clinical Details
Official title: [11C] Sertraline PET Imaging Study That Investigates Pharmacokinetics and Pharmacodynamics of Sertraline After Low Dose Administration
Study design: Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Serotonin receptor occupancy
Secondary outcome: Plasma concentration of sertraline
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
Minimum age: 20 Years.
Maximum age: 50 Years.
Gender(s): Male.
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
Locations and Contacts
Kyung-Sang Yu, MD, PhD, Phone: +82-2072-1920, Email: ksyu@snu.ac.kr
Clinical Trials Center, Seoul National University Hospital, Seoul 110-744, Korea, Republic of; Recruiting
Kyung-Sang Yu, PhD, Phone: 82-2-2072-1920, Email: ksyu@snu.ac.kr
In-Jin Jang, MD, PhD, Sub-Investigator
Jae-Min Jung, PhD, Sub-Investigator
Jae Sung Lee, PhD, Sub-Investigator
Won-Sik Ahn, MD, PhD, Sub-Investigator
Additional Information
Starting date: July 2009
Last updated: August 31, 2009
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