Blood Naloxone Levels Following Intradermal Injection in Humans

Johns Hopkins University

Status and phase: Withdrawn; Phase 4

Conditions: Opioid Overdose

Treatments: Drug: intradermal naloxone; Device: microneedle injection

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05876572

IRB00380585

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Ability to participate in the informed consent process
• Good peripheral venous access for proposed pharmacokinetic sampling
• Has not taken an investigational drug within prior 30 days (or 5 half-lives, whichever is longer)

Exclusion criteria

• Allergy to Naloxone or vehicle constituents (namely parabens)
• Active substance use as defined by a positive screen for drugs of abuse within seven days of study participation
• History of substance use disorder
• Taking opiate/opioid medications for any indication
• Chronic pain disorder
• Pregnant or breastfeeding
• Adults lacking capacity to consent, non-English speaking persons, or prisoners.
• Other medical history or active conditions deemed not safe for participation by the investigator
• Hematocrit <35%

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

healthy volunteer adults

Other group

Treatment:

Device: microneedle injection

Drug: intradermal naloxone