- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02131545
Pharmacokinetic Study Comparing Topical, Rectal, and Oral Quetiapine
April 21, 2017 updated by: Jonathan G. Leung, Pharm.D., R.Ph., Mayo Clinic
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.
Study Overview
Status
Completed
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Quetiapine
Quetiapine 25 mg
|
Quetiapine 25 mg gel applied topically; 9 serum quetiapine levels drawn over the course of 8 hours
Other Names:
Quetiapine 25 mg tablet administered by mouth; 9 serum quetiapine levels drawn over the course of 8 hours
Other Names:
Quetiapine 25 mg suppository administered rectally; 9 serum quetiapine levels drawn over the course of 8 hours
Other Names:
Quetiapine 75 mg gel applied topically every 4 hours for 24 hours; 6 serum quetiapine levels drawn over the course of 24 hours
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum quetiapine levels after topical application (Visit 1)
Time Frame: 8 hours
|
Areas under the curve versus time
|
8 hours
|
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
|
8 hours (no sooner than 72 hours from end of visit 1)
|
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
|
8 hours (no sooner than 72 hours from end of visit 2)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum quetiapine levels after topical administration over 24 hours
Time Frame: 24 hours
|
Topical quetiapine applied every 4 hours for 24 hours
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jonathan Leung, PharmD, RPh, Mayo Clinic
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2014
Primary Completion (Actual)
July 1, 2016
Study Completion (Actual)
July 1, 2016
Study Registration Dates
First Submitted
May 1, 2014
First Submitted That Met QC Criteria
May 5, 2014
First Posted (Estimate)
May 6, 2014
Study Record Updates
Last Update Posted (Actual)
April 25, 2017
Last Update Submitted That Met QC Criteria
April 21, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Confusion
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Delirium
- Dementia
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Antidepressive Agents
- Quetiapine Fumarate
Other Study ID Numbers
- 14-000896
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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