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Pharmacokinetic Study Comparing Topical, Rectal, and Oral Quetiapine

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ClinicalTrials.gov Identifier: NCT02131545
Recruitment Status : Completed
First Posted : May 6, 2014
Last Update Posted : April 25, 2017
Sponsor:
Information provided by (Responsible Party):
Jonathan G. Leung, Pharm.D., R.Ph., Mayo Clinic

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dementia Delirium Drug: Quetiapine 25 mg gel applied topically Drug: Quetiapine 25 mg tablet by mouth Drug: Quetiapine 25 mg rectal suppository Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Single Dose Pharmacokinetic Study of Topical and Rectal Quetiapine Compared to Oral Quetiapine in Healthy Adults
Actual Study Start Date : June 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Quetiapine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Quetiapine
Quetiapine 25 mg
 Drug: Quetiapine 25 mg gel applied topically
Quetiapine 25 mg gel applied topically; 9 serum quetiapine levels drawn over the course of 8 hours
Other Name: Seroquel

Drug: Quetiapine 25 mg tablet by mouth
Quetiapine 25 mg tablet administered by mouth; 9 serum quetiapine levels drawn over the course of 8 hours
Other Name: Seroquel

Drug: Quetiapine 25 mg rectal suppository
Quetiapine 25 mg suppository administered rectally; 9 serum quetiapine levels drawn over the course of 8 hours
Other Name: Quetiapine

Drug: Quetiapine 25 mg gel applied topically
Quetiapine 75 mg gel applied topically every 4 hours for 24 hours; 6 serum quetiapine levels drawn over the course of 24 hours
Other Name: Seroquel


Outcome Measures
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Primary Outcome Measures :
  1. Serum quetiapine levels after topical application (Visit 1) [ Time Frame: 8 hours ]
    Areas under the curve versus time

  2. Serum quetiapine levels after oral administration (Visit 2) [ Time Frame: 8 hours (no sooner than 72 hours from end of visit 1) ]
    Areas under the curve versus time

  3. Serum quetiapine levels after rectal administration (Visit 3) [ Time Frame: 8 hours (no sooner than 72 hours from end of visit 2) ]
    Areas under the curve versus time


Secondary Outcome Measures :
  1. Serum quetiapine levels after topical administration over 24 hours [ Time Frame: 24 hours ]
    Topical quetiapine applied every 4 hours for 24 hours


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02131545


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Jonathan Leung, PharmD, RPh Mayo Clinic
More Information
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Responsible Party: Jonathan G. Leung, Pharm.D., R.Ph., Psychiatric Clinical Pharmacist, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02131545    
Other Study ID Numbers: 14-000896
First Posted: May 6, 2014    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Jonathan G. Leung, Pharm.D., R.Ph., Mayo Clinic:
quetiapine
pharmacokinetics
dementia
delirium
palliative care
Additional relevant MeSH terms:
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Dementia
Delirium
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Confusion
Neurobehavioral Manifestations
 Neurologic Manifestations
Quetiapine Fumarate
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs