Blood Naloxone Levels Following Intradermal Injection in Humans

Status Not yet recruiting

Clinical Trial Summary

The main purpose of this study is to evaluate pharmacokinetics/pharmacodynamics of intradermal administration of naloxone in healthy adult subjects.

Clinical Trial Description

Using approved drug formulations, injection devices, and assays, the investigators seek to determine the pharmacokinetics and pharmacodynamics of naloxone in human subjects using an intradermal delivery route. The long-term goal is to develop a product with better pharmacokinetic (PK) and pharmacodynamic (PD) properties than current delivery systems used in opioid overdose rescue. To the best of the investigators knowledge, this is the first study administering naloxone via an intradermal route in humans. Using an FDA-approved intranasal drug formulation, the investigators will administer 8mg/0.1ml of naloxone into the highly vascular dermal layer of the skin using microneedles in 3 healthy volunteer participants and measure plasma concentrations of naloxone for 60 minutes after injection. The investigators primary outcome measure is detectable levels of naloxone in plasma. Secondary outcome measures will be estimates of PK values derived from time versus concentration data. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05876572
Study type	Interventional
Source	Johns Hopkins University
Contact	Jennifer Hoffmann, CRNP
Phone	4109551618
Email	jhoffm45@jhmi.edu
Status	Not yet recruiting
Phase	Phase 4
Start date	August 2024
Completion date	December 2024

View Details

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