Blood Naloxone Levels Following Intradermal Injection in Humans

NCT05876572 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: IRB00380585
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Opioid Overdose

Keywords

naloxone; pharmacokinetics; pharmacodynamics; intradermal; Opioid receptor

Outcome Measures

Primary Outcomes (1)

• Detection of Plasma Naloxone Concentration (ng/mL) using High Performance Liquid Chromatography/Tandem Mass Spectrometry (HPLC-MS/MS).

  Plasma Naloxone concentration (ng/mL) will be measured using HPLC-MS/MS at multiple timepoints following an intradermal injection of 8mg dose of Naloxone. The primary outcome is the presence or absence of detectable Naloxone at any time point. Time points include T0 (pre-Naloxone), 1, 2, 4, 6, 8, 12.5, 15, 30, 45, and 60 minutes after Naloxone treatment. Multiples of time points between participants will be taken as a simple mean average for that specific time point, and any samples below the limit of assay detection will be excluded from calculation.

  up to 60 minutes

Secondary Outcomes (3)

• Measurement of the maximum plasma concentration (Cmax; ng/mL) of Naloxone using HPLC-MS/MS following a single 8mg dose of intradermally delivered Naloxone.

  up to 60 minutes

• 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.

  up to 60 minutes

• 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.

  up to 60 minutes

Study Arms (1)

healthy volunteer adults

OTHER

Drug: intradermal naloxone; Device: microneedle injection

Interventions

intradermal naloxone DRUG

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

healthy volunteer adults

microneedle injection DEVICE

Intradermal delivery of naloxone using microneedle

healthy volunteer adults

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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%

Sponsors & Collaborators

• Johns Hopkins University: lead
• DEKA S.r.l.: collaborator

MeSH Terms

Conditions

Opiate Overdose

Condition Hierarchy (Ancestors)

Drug Overdose; Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders; Narcotic-Related Disorders; Mental Disorders

Study Officials

• Kathryn Rosenblatt, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: May 25, 2023
• Study Start: August 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share