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Completed

NCT Number: NCT02131545

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.

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Key information

Conditions

Dementia Brain Diseases Central Nervous System Diseases Confusion Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:

  • 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
  • Contraindications for suppository administration
  • With Ostomy, chronic diarrhea
  • Diabetes, type 1 or type 2
  • Prolong corrected QT interval (>470 msec) or history of congenital long QT syndrome
  • Open wound(s) or unhealed wound(s) at topical medication application site (anterior forearm)
  • Active or latent tuberculous and currently prescribed pharmacotherapy treatments
  • 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
  • Vulnerable populations will be excluded (i.e. prisoners, wards of the state, emancipated minors, children, pregnant women)
  • Inability to receive telephone calls for the purpose of post-intervention follow-up
  • Inability or unwillingness of individual to give written informed consent
  • Non-English speaking populations

Treatment and study plan

Quetiapine 25 mg gel applied topically

Drug

Quetiapine 25 mg gel applied topically; 9 serum quetiapine levels drawn over the course of 8 hours

Other names: Seroquel

Quetiapine 25 mg tablet by mouth

Drug

Quetiapine 25 mg tablet administered by mouth; 9 serum quetiapine levels drawn over the course of 8 hours

Other names: Seroquel

Quetiapine 25 mg rectal suppository

Drug

Quetiapine 25 mg suppository administered rectally; 9 serum quetiapine levels drawn over the course of 8 hours

Other names: Quetiapine

Primary outcomes

  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 outcomes

  1. Serum quetiapine levels after topical administration over 24 hours

    Time frame: 24 hours

    Topical quetiapine applied every 4 hours for 24 hours

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

A Single Dose Pharmacokinetic Study of Topical and Rectal Quetiapine Compared to Oral Quetiapine in Healthy Adults

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 6, 2014
Registry last updated
Apr 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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