A Single Dose Pharmacokinetic Study of Topical and Rectal Quetiapine Compared to Oral Quetiapine in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Serum quetiapine levels after topical application (Visit 1)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •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
- •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
- 另有 14 项未显示
排除标准
- 未提供
研究组 & 干预措施
Quetiapine
Quetiapine 25 mg
干预措施: Quetiapine 25 mg gel applied topically (Drug)
Quetiapine
Quetiapine 25 mg
干预措施: Quetiapine 25 mg tablet by mouth (Drug)
Quetiapine
Quetiapine 25 mg
干预措施: Quetiapine 25 mg rectal suppository (Drug)
结局指标
主要结局
Serum quetiapine levels after topical application (Visit 1)
时间窗: 8 hours
Areas under the curve versus time
Serum quetiapine levels after oral administration (Visit 2)
时间窗: 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)
时间窗: 8 hours (no sooner than 72 hours from end of visit 2)
Areas under the curve versus time
次要结局
- Serum quetiapine levels after topical administration over 24 hours(24 hours)
研究者
Jonathan G. Leung, Pharm.D., R.Ph.
Psychiatric Clinical Pharmacist
Mayo Clinic