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CompletedPhase 1

Pharmacokinetic Study Comparing Topical, Rectal, and Oral Quetiapine

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

Lead sponsor

Mayo Clinic

Asset

Quetiapine

Listed sites

Recruiting sites

Enrollment

actual

Study population

Mixed / unspecified dementia

Key I/E criterion

•Age 18-65

Primary endpoints

•Serum quetiapine levels after topical application (Visit 1)•Serum quetiapine levels after oral administration (Visit 2)•Serum quetiapine levels after rectal administration (Visit 3)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID14-000896

NCT IDNCT02131545

Timeline

Milestones

Study first posted2014-05-06estimated

Study start2014-06actual (month precision)

Primary completion2016-07actual (month precision)

Study completion2016-07actual (month precision)

Last update posted2017-04-25actual

Assets

Drug assets

Quetiapine

Study populations

Who this study enrolls

Mixed / unspecified dementia

Eligibility

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersAccepted

Eligibility 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

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Other (unclassified)

4 endpoints

Primary/protocol endpoint/low confidence

Serum quetiapine levels after topical application (Visit 1)

Time frame:8 hours

descriptive

Primary/protocol endpoint/low confidence

Serum quetiapine levels after oral administration (Visit 2)

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

ratio, descriptive

Primary/protocol endpoint/low confidence

Serum quetiapine levels after rectal administration (Visit 3)

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

ratio, descriptive

Secondary/protocol endpoint/low confidence

Serum quetiapine levels after topical administration over 24 hours

Time frame:24 hours

ratio, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.