NCT05876572

Blood Naloxone Levels Following Intradermal Injection in Humans

A Pharmacokinetic/Pharmacodynamic (PK/PD) Evaluation of Naloxone Following Intradermal Injection in Humans

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Opioid Overdose

Interventions

Type	Name	Description
DRUG	intradermal naloxone	One time 8 mg/0.1 mL dose of naloxone to be administered intradermally
DEVICE	microneedle injection	Intradermal delivery of naloxone using microneedle

Timeline

• Start date: 2024-08-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2023-05-25
• Last updated: 2024-11-01

Regulatory

• FDA-regulated drug study