Pharmacokinetic Study Comparing Topical, Rectal, and Oral Quetiapine
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Psychiatric |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 7/28/2016 |
| Start Date: | June 2014 |
| End Date: | July 2016 |
A Single Dose Pharmacokinetic Study of Topical and Rectal Quetiapine Compared to Oral Quetiapine in Healthy Adults
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.
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
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