Central Nervous System Effects Following Infusion of Diphenhydramine Using Pharmacokinetic and Pharmacodynamic Modeling

Dent Neuroscience Research Center

Status and phase: Terminated; Phase 4

Conditions: Pharmacokinetics of Diphenhydramine; Central Nervous System Effects of Diphenhydramine

Treatments: Drug: DiphenhydrAMINE Injectable Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT05219604

DIP-PKPD

Details and patient eligibility

About

This study seeks to explore the magnitude and duration of central nervous system effects and pharmacokinetics after intravenous infusion of diphenhydramine.

Enrollment: 3 patients

Sex: All

Ages: 35+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Medically-stable volunteers of either gender between 35 and 50 years old or over the age of 65
2. No medication changes anticipated for the duration of the study except as defined in protocol

Exclusion criteria

1. Insulin-dependent diabetes
2. Psychiatric or neurologic disease affecting cognition in a way that may interfere with study outcomes in the opinion of the investigator
3. Unstable Coronary Artery Disease (active angina, MI within 6 months, stent placement within 6 months, cardiac surgery within 6 months)
4. Estimated CrCl < 30 mL/min using the Cockroft-Gault equation based on ideal body weight or total body weight
5. Any malignancy actively being treated or not in remission
6. 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
7. Positive toxicology test for marijuana at screening visit or visit 2 or using marijuana not as defined in the protocol
8. Active or recent history of a substance use disorder within one year
9. Any medical condition that in the opinion of the investigator would disqualify the subject from participation in the study
10. Female subjects who are pregnant, planning to become pregnant, or breastfeeding on any study day
11. Female subjects of childbearing potential unwilling to use acceptable method of contraception during the study as defined in the protocol
12. Contraindication, known allergy, or suspected intolerability to study medication
13. 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
14. Positive toxicology test for a drug that is inconsistent with permitted medication use (defined in the protocol) as interpreted by the investigator
15. Participation in any other investigational drug study during the study or within 4 weeks prior to screening

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)