Pharmacokinetics and Pharmacodynamics of Sertraline After Low Dose Administration

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Seoul National University

Status and phase

Completed
Phase 4

Conditions

Healthy

Treatments

Drug: Sertraline

Study type

Interventional

Funder types

Other

Identifiers

NCT00969852
SNUCPT09_Sertraline

Details and patient eligibility

About

This study aimed to explore the pharmacokinetics and pharmacodynamics of low dose sertraline with [11C] sertraline positron emission tomography (PET) study.

Full 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.

Enrollment

10 estimated patients

Sex

Male

Ages

20 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

10 participants in 1 patient group

Sertraline
Experimental group
Description:
Single Arm
Treatment:
Drug: Sertraline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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