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Clinical Study to Investigate the Pharmacokinetics of Multiple Repeated Doses of Intranasal Naloxone

NCT04764630 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2024-04-19

Study results available
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Summary

Intranasal (IN) naloxone is available as 2 mg or 4 mg dose with the indication to re-administer additional doses every 2 to 3 minutes (using alternating nostrils) if needed until emergency medical assistance arrives. The 4 mg dose is distributed in packages of two nasal sprays (1 dose per nasal spray), but additional doses can be administered if needed and available.

While the pharmacokinetics of IN naloxone have been determined following administration of a 4 mg dose in each nostril concurrently, the pharmacokinetics have not been determined following multiple doses when there is a 2-3 minute delay between doses and when doses are re-administered to the same nostril.

Obtaining data with repeat dosing will inform if and how fast naloxone plasma concentrations can be reached to be able to reverse highly-potent opioid overdoses. This study will be a randomized, unblinded, three-way crossover study to determine naloxone plasma concentration after administration of multiple doses:

A. Four 4 mg IN naloxone doses (1 dose every 2.5 minutes) B. Four 4 mg IN naloxone doses (2 doses every 2.5 minutes) C. Two 4 mg IN naloxone doses (1 dose every 2.5 minutes)

Conditions

  • Healthy Subjects
  • Opioid Antagonist
  • Pharmacokinetics

Interventions

DRUG

Four naloxone nasal spray doses (1 every 2.5 min)

Four 4 mg IN naloxone doses (left nostril at 0 min, right nostril at 2.5 min, left nostril at 5 min, right nostril at 7.5 min

DRUG

Four naloxone nasal spray doses (2 every 2.5 min)

Four 4 mg IN naloxone doses (left and right nostrils at 0 min, left and right nostrils at 2.5 min)

DRUG

Two naloxone nasal spray doses (1 every 2.5 min)

Two 4 mg IN naloxone doses (left nostril at 0 min, right nostril at 2.5 min)

Sponsors & Collaborators

  • Spaulding Clinical Research LLC

    collaborator OTHER

  • Food and Drug Administration (FDA)

    lead FED

Principal Investigators

  • Jennifer Deering, MSN, APNP · Spaulding Clinical Research LLC

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2021-03-20
Completion
2021-03-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04764630 on ClinicalTrials.gov