NCT05219604终止4 期
The Magnitude and Duration of the Central Nervous System Effects Following Intravenous Infusion of Diphenhydramine Using Pharmacokinetic and Pharmacodynamic Modeling
Dent Neuroscience Research Center1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2022年3月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Change in score of battery of cognitive function tests
研究概览
简要总结
This study seeks to explore the magnitude and duration of central nervous system effects and pharmacokinetics after intravenous infusion of diphenhydramine.
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
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Medically-stable volunteers of either gender between 35 and 50 years old or over the age of 65
- •No medication changes anticipated for the duration of the study except as defined in protocol
排除标准
- •Insulin-dependent diabetes
- •Psychiatric or neurologic disease affecting cognition in a way that may interfere with study outcomes in the opinion of the investigator
- •Unstable Coronary Artery Disease (active angina, MI within 6 months, stent placement within 6 months, cardiac surgery within 6 months)
- •Estimated CrCl < 30 mL/min using the Cockroft-Gault equation based on ideal body weight or total body weight
- •Any malignancy actively being treated or not in remission
- •Currently taking any CNS stimulant or depressant medications that may interfere with study outcomes in the opinion of the investigator unless using as defined in the protocol
- •Positive toxicology test for marijuana at screening visit or visit 2 or using marijuana not as defined in the protocol
- •Active or recent history of a substance use disorder within one year
- •Any medical condition that in the opinion of the investigator would disqualify the subject from participation in the study
- •Female subjects who are pregnant, planning to become pregnant, or breastfeeding on any study day
- •Female subjects of childbearing potential unwilling to use acceptable method of contraception during the study as defined in the protocol
- •Contraindication, known allergy, or suspected intolerability to study medication
- •Receipt of an antihistamine within 5 half-lives prior to the start of study visit 1 or study visit 2, as determined by the investigator
- •Positive toxicology test for a drug that is inconsistent with permitted medication use (defined in the protocol) as interpreted by the investigator
- •Participation in any other investigational drug study during the study or within 4 weeks prior to screening
结局指标
主要结局
Change in score of battery of cognitive function tests
时间窗: Change from before to after diphenhydramine administration (30, 60, 210, 240, 450, and 480 minutes after diphenhydramine)
Change in the results of the CANTAB battery of cognitive function tests (reaction time, rapid visual information processing, paired associates learning, spatial working memory, digit span) and visual analog scale for sedation after diphenhydramine administration compared to baseline
次要结局
- Elderly vs. adult change in score of battery of cognitive function tests after diphenhydramine(After diphenhydramine administration (30, 60, 210, 240, 450, 480 minutes after diphenhydramine administration))
- Elderly vs. adult score of battery of cognitive function tests at specified time points(Before and after diphenhydramine administration (30, 60, 210, 240, 450, 480 minutes after diphenhydramine administration))
- Elderly vs. adult diphenhydramine AUC(Immediately after diphenhydramine administration to 480 minutes after diphenhydramine administration)
研究者
研究点 (1)
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