Pharmacokinetic Study Comparing Topical, Rectal, and Oral Quetiapine

Completed · Phase 1

Conditions studied: Dementia, Delirium

In brief

Quetiapine, a second generation antipsychotic, is only available as oral tablets. However, topical and rectal formulations have been produced in compounding pharmacies. There is no data available suggesting that topical or rectal formulations provide serum levels similar to oral medication. In the clinical setting, when oral administration of quetiapine is not possible (for example, when a patient is extremely ill physically or mentally or both), clinicians and pharmacists have collaborated in such cases and have at times had to administer quetiapine compounded in other dosage formulations such as rectal or topical formulations. Despite clinical effectiveness of these other formulations, there are no available studies that have investigated blood levels of the drug other than the oral form. The investigators are therefore designing this pharmacokinetic study to evaluate the the systemic absorption of quetiapine in oral, rectal and topical formulations. If the investigators are able to demonstrate detectable levels from rectal and topical quetiapine formulations compared to the oral form, this knowledge will enhance clinical psychiatric practice by providing a more broad route of administration for quetiapine which is a commonly used drug for psychiatric symptoms.

Key facts

Study ID

NCT02131545

Run by

Mayo Clinic

People needed

10

Starts

2014-06-01

Expected to finish

2016-07-01

Last updated by the study team

2017-04-25

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy adult volunteers (18-65 years old) willing to undergo a general health screen consisting of blood pressure, heart rate, respiratory rate, height, weight, temperature, and electrocardiogram will be identified.
• The below parameters must be met to be consider an adult healthy to volunteer for inclusion in this study:
• Blood pressure less than 160/99 mmHg and greater than 105/50 mmHg
• Heart rate between 50-100 beats per minutes
• Respiratory rate between 10-30 breaths per minute
• Temperature between 34 °C and 37.5°F
• Corrected QT interval of < 470 msec
• Liver function tests less than 1.5 times the upper limit of normal
• Estimated creatinine clearance (estimated by Cockcroft Gault formulation) greater than 60 mL/min
• Female participants will complete a urine pregnancy test that must result in a negative finding
• Exclusion:
• Allergy to quetiapine, Lipoderm or polyethylene glycol
• Currently taking quetiapine
• Pregnant, planning to become pregnant or breast feeding
• Over or under 30% of ideal body weight
• History of or active cardiovascular disease (except hypertension meeting the inclusion criteria for blood pressure), severe kidney disease (i.e. needing dialysis), or liver disease
• History of schizophrenia, bipolar disorder, substance use disorders (but excluding nicotine use disorders and stable unipolar depression (See below))
• Unstable unipolar depression, defined as hospitalization for depression within 1 year or changes to an antidepressant regimen within 6 months
• History of seizure or seizure disorder
• Parkinson's disease, Huntington's disease, tardive dyskinesia or other diagnosed movement disorder
• History of/or active hematologic/oncologic illness
• Dementia
• Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome
• History of organ transplant
• History of gastric bypass

Where it is running

• Mayo Clinic in Rochester — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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