Blood Naloxone Levels Following Intradermal Injection in Humans

NCT ID: NCT05876572

Last Updated: 2024-11-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-31
• Study Completion Date: 2024-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

healthy volunteer adults

Group Type: OTHER

intradermal naloxone

Intervention Type: DRUG

One time 8 mg/0.1 mL dose of naloxone to be administered intradermally

microneedle injection

Intervention Type: DEVICE

Intradermal delivery of naloxone using microneedle

Interventions

intradermal naloxone

One time 8 mg/0.1 mL dose of naloxone to be administered intradermally

Intervention Type: DRUG

microneedle injection

Intradermal delivery of naloxone using microneedle

Intervention Type: DEVICE

Eligibility Criteria

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%

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

DEKA S.r.l.

INDUSTRY

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kathryn Rosenblatt, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Other Identifiers

IRB00380585

Identifier Type: -

Identifier Source: org_study_id