Pharmacokinetic Study Comparing Topical, Rectal, and Oral Quetiapine
Pharmacokinetic Study Comparing Topical, Rectal, and Oral Quetiapine
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.
Inclusion Criteria:

 -  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:

 1. Allergy to quetiapine, Lipoderm or polyethylene glycol

 2. Currently taking quetiapine

 3. Pregnant, planning to become pregnant or breast feeding

 4. Over or under 30% of ideal body weight

 5. 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

 6. History of schizophrenia, bipolar disorder, substance use disorders (but excluding
 nicotine use disorders and stable unipolar depression (See below))

 7. Unstable unipolar depression, defined as hospitalization for depression within 1 year
 or changes to an antidepressant regimen within 6 months

 8. History of seizure or seizure disorder

 9. Parkinson's disease, Huntington's disease, tardive dyskinesia or other diagnosed
 movement disorder

 10. History of/or active hematologic/oncologic illness

 11. Dementia

 12. Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome

 13. History of organ transplant

 14. History of gastric bypass

 15. Contraindications for suppository administration

 16. With Ostomy, chronic diarrhea

 17. Diabetes, type 1 or type 2

 18. Prolong corrected QT interval (>470 msec) or history of congenital long QT syndrome

 19. Open wound(s) or unhealed wound(s) at topical medication application site (anterior
 forearm)

 20. Active or latent tuberculous and currently prescribed pharmacotherapy treatments

 21. Currently prescribed or taken with in the last 7 days, medications which have a known
 interaction with quetiapine or compound the risk of adverse events associated with
 quetiapine:

 -  QTc prolonging medications:

 -  Antipsychotics

 -  Vaughan Williams Class IA, IB, IC, III antiarrhythmics

 -  Anti-infective agents (excluding topical agents, oral penicillins, oral
 cephalosporins)

 -  Antiemetics

 -  Methadone

 -  Cisapride

 -  Cimetidine

 -  Divalproex sodium/valproic acid

 -  Tetrabenazine

 -  Solifenacin

 -  Tricyclic antidepressants

 -  Tizanidine

 -  Fingolimod

 -  Increase quetiapine concentrations, not previously mentioned

 -  Paroxetine

 -  Fluoxetine

 -  Fluvoxamine

 -  Non-dihydropyridine calcium channel blockers (verapamil, diltiazem)

 -  Tamoxifen

 -  Cyclosporin (excluding ophthalmic formulation)

 -  Nefazodone

 -  Decrease quetiapine levels, not previously mentioned

 -  Bosentan

 -  Carbamazepine

 -  Glucocorticoids

 -  Modafinil

 -  Primidone

 -  St. John's wort

 -  Barbiturates

 -  Phenytoin

 22. Vulnerable populations will be excluded (i.e. prisoners, wards of the state,
 emancipated minors, children, pregnant women)

 23. Inability to receive telephone calls for the purpose of post-intervention follow-up

 24. Inability or unwillingness of individual to give written informed consent

 25. Non-English speaking populations