Pharmacokinetic Study Comparing Topical, Rectal, and Oral Quetiapine

NCT02131545 | Completed Phase 1 FDA Drug

• 1 other identifier: 14-000896
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia; Delirium

Keywords

quetiapine; pharmacokinetics; dementia; delirium; palliative care

Outcome Measures

Primary Outcomes (3)

• Serum quetiapine levels after topical application (Visit 1)

  Areas under the curve versus time

  8 hours

• Serum quetiapine levels after oral administration (Visit 2)

  Areas under the curve versus time

  8 hours (no sooner than 72 hours from end of visit 1)

• Serum quetiapine levels after rectal administration (Visit 3)

  Areas under the curve versus time

  8 hours (no sooner than 72 hours from end of visit 2)

Secondary Outcomes (1)

• Serum quetiapine levels after topical administration over 24 hours

  24 hours

Study Arms (1)

Quetiapine

EXPERIMENTAL

Quetiapine 25 mg

Drug: Quetiapine 25 mg gel applied topically; Drug: Quetiapine 25 mg tablet by mouth; Drug: Quetiapine 25 mg rectal suppository

Interventions

Quetiapine 25 mg gel applied topically DRUG

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

Also known as: Seroquel

Quetiapine

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

Also known as: Seroquel

Quetiapine

Quetiapine 25 mg rectal suppository DRUG

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

Also known as: Quetiapine

Quetiapine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Dementia; Delirium

Interventions

Quetiapine Fumarate; Suppositories

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Jonathan Leung, PharmD, RPh

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychiatric Clinical Pharmacist

Study Record Dates

• First Submitted: May 1, 2014
• First Posted: May 6, 2014
• Study Start: June 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: April 25, 2017

Record last verified: 2017-04

Locations

US (1)