Status:
TERMINATED
Central Nervous System Effects Following Infusion of Diphenhydramine Using Pharmacokinetic and Pharmacodynamic Modeling
Lead Sponsor:
Dent Neuroscience Research Center
Conditions:
Central Nervous System Effects of Diphenhydramine
Pharmacokinetics of Diphenhydramine
Eligibility:
All Genders
35+ years
Phase:
PHASE4
Brief Summary
This study seeks to explore the magnitude and duration of central nervous system effects and pharmacokinetics after intravenous infusion of diphenhydramine.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 4 2022
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT05219604
Start Date
March 15 2022
End Date
October 4 2022
Last Update
February 14 2024
Active Locations (1)
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1
Dent Neurologic Institute
Amherst, New York, United States, 14226