DementiaPhase 1NCT02131545
Pharmacokinetic Study Comparing Topical, Rectal, and Oral Quetiapine
A Phase 1 study testing Quetiapine 25 mg gel applied topically, Quetiapine 25 mg tablet by mouth and Quetiapine 25 mg rectal suppository in people with Dementia and Delirium, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- What is being tested?
- Quetiapine 25 mg gel applied topically, Quetiapine 25 mg tablet by mouth and Quetiapine 25 mg rectal suppository
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Jul 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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))
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: 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.
- Being tested
- Quetiapine 25 mg gel applied topically, Quetiapine 25 mg tablet by mouth, Quetiapine 25 mg rectal suppository
- Keywords
- quetiapine, pharmacokinetics, dementia, delirium, palliative care
- Medical subject headings
- Dementia, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quetiapine 25 mg gel applied topicallyDrug
Also called Seroquel
Quetiapine 25 mg gel applied topically; 9 serum quetiapine levels drawn over the course of 8 hours
Quetiapine 25 mg tablet by mouthDrug
Also called Seroquel
Quetiapine 25 mg tablet administered by mouth; 9 serum quetiapine levels drawn over the course of 8 hours
Quetiapine 25 mg rectal suppositoryDrug
Also called Quetiapine
Quetiapine 25 mg suppository administered rectally; 9 serum quetiapine levels drawn over the course of 8 hours
Quetiapine 25 mg gel applied topicallyDrug
Also called Seroquel
Quetiapine 75 mg gel applied topically every 4 hours for 24 hours; 6 serum quetiapine levels drawn over the course of 24 hours
| Study group | Role | What they receive |
|---|---|---|
| Quetiapine | Experimental | Quetiapine 25 mg Receives: Drug: Quetiapine 25 mg gel applied topically; Drug: Quetiapine 25 mg tablet by mouth; Drug: Quetiapine 25 mg rectal suppository |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum quetiapine levels after topical application (Visit 1)
Areas under the curve versus time
Measured: 8 hours
Serum quetiapine levels after oral administration (Visit 2)
Areas under the curve versus time
Measured: 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
Measured: 8 hours (no sooner than 72 hours from end of visit 2)
Secondary outcomes (1)
Serum quetiapine levels after topical administration over 24 hours
Topical quetiapine applied every 4 hours for 24 hours
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2014 (estimated)
- Study startJun 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan G. Leung, Pharm.D., R.Ph., Mayo Clinic
- Investigators
- Jonathan Leung, PharmD, RPh, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02131545
- Sponsor's protocol ID
- 14-000896
- Status last verified
- Apr 2017
- First submitted
- 1 May 2014
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose Pharmacokinetic Study of Topical and Rectal Quetiapine Compared to Oral Quetiapine in Healthy Adults
- ClinicalTrials.gov ID
- NCT02131545
- Acronym / sponsor ID
- 14-000896
- Keywords
- quetiapine, pharmacokinetics, dementia, delirium, palliative care
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 6 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Quetiapine | Experimental | Drug: Quetiapine 25 mg gel applied topically, Drug: Quetiapine 25 mg tablet by mouth, Drug: Quetiapine 25 mg rectal suppositoryQuetiapine 25 mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (56 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quetiapine 25 mg gel applied topicallyAlso: SeroquelQuetiapine 25 mg gel applied topically; 9 serum quetiapine levels drawn over the course of 8 hours | Drug | Quetiapine |
| Quetiapine 25 mg tablet by mouthAlso: SeroquelQuetiapine 25 mg tablet administered by mouth; 9 serum quetiapine levels drawn over the course of 8 hours | Drug | Quetiapine |
| Quetiapine 25 mg rectal suppositoryAlso: QuetiapineQuetiapine 25 mg suppository administered rectally; 9 serum quetiapine levels drawn over the course of 8 hours | Drug | Quetiapine |
| Quetiapine 25 mg gel applied topicallyAlso: SeroquelQuetiapine 75 mg gel applied topically every 4 hours for 24 hours; 6 serum quetiapine levels drawn over the course of 24 hours | Drug | Quetiapine |
Primary outcome
Serum quetiapine levels after topical application (Visit 1)
Time frame: 8 hours
Areas under the curve versus time
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
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
1 secondary outcome
Serum quetiapine levels after topical administration over 24 hours
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Leung, PharmD, RPh principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Quetiapine 25 mg gel applied topically, Quetiapine 25 mg tablet by mouth and Quetiapine 25 mg rectal suppository in people with Dementia and Delirium, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 56 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum quetiapine levels after topical application (Visit 1) (time frame: 8 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2017.