Clinical trial NCT05876572: Blood Naloxone Levels Following Intradermal Injection in Humans
Official title: A Pharmacokinetic/Pharmacodynamic (PK/PD) Evaluation of Naloxone Following Intradermal Injection in Humans
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Opioid Overdose
Keywords: naloxone
pharmacokinetics
pharmacodynamics
intradermal
Opioid receptor
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: DEKA S.r.l.
First posted: 2023-05-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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%

Primary outcomes:
measure: Detection of Plasma Naloxone Concentration (ng/mL) using High Performance Liquid Chromatography/Tandem Mass Spectrometry (HPLC-MS/MS).
timeFrame: up to 60 minutes
Secondary outcomes:
measure: Measurement of the maximum plasma concentration (Cmax; ng/mL) of Naloxone using HPLC-MS/MS following a single 8mg dose of intradermally delivered Naloxone.
timeFrame: up to 60 minutes
measure: Assessment of the time (minutes) at which the maximum Naloxone concentration (ng/mL) is detected in plasma (Tmax) by HPLC-MS/MS after a single 8mg dose of intradermally delivered Naloxone.
timeFrame: up to 60 minutes
measure: Assessment of Naloxone exposure (mg*h/L) over 60 minutes (AUC 0-60) as measured by HPLC-MS/MS of plasma samples collected after a single 8mg dose of intradermally delivered Naloxone.
timeFrame: up to 60 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins University
name: Kathryn Rosenblatt, MD
role: PRINCIPAL_INVESTIGATOR
References: