A Pilot Study of the Bioavailability of Nasal Naloxone

October 27, 2021 updated by: Norwegian University of Science and Technology

The overall is aim of this pilot study is to give a preliminary estimation of key parameters of the pharmacokinetics of a proper formulation of intranasal naloxone. These data will be used to design a well justified protocol for the final estimation of these parameters:

  • Preliminary estimation of bioavailability of this intranasal naloxone in human, healthy volunteers
  • Preliminary estimation of the maximum serum concentration (Cmax) of this formulation
  • Preliminary estimation of the time to maximum serum concentration (Tmax) of this formulation
  • Safety of the formulation

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway
        • Department of circulation and medical imaging, NTNU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • healthy (adequate organ function is determined by electrocardiogram (ECG), liver and kidney clinical chemistry, and a standard clinical examination/interview. For safety reasons we may ask for urine sample for analysis of opioids)
  • informed consent

Exclusion Criteria:

  • history of liver disease
  • taking any medications including herbal medicines the last week history of drug abuse
  • any local nasal disease or nasal surgery or recent cold for the last week
  • any history of drug allergies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: naloxone intranasal
2.0 mg by the nasal route
Drug: naloxone intranasal
If bioavailability is 20% or 50 %, the dose will be equivalent to the clinical range 0.4 - 1.0 mg given parenterally
ACTIVE_COMPARATOR: naloxone intravenous
1.0 mg intravenous
Drug: naloxone intravenous
The parenteral dose reflects clinically used doses for overdoses (0.4 - 1.0 mg). A washout period of at least 3 days between each intervention. IV naloxone (Naloxone B. Braun 0.4mg/ml) administered slowly over 1-2 min in the recumbent position

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
preliminary bioavailability of nasal naloxone
Time Frame: 2 weeks
measured as ratio of area under the time concentration curve for nasal over intravenous naloxone x 100. Plasma concentration data will be analyzed by non-compartmental techniques.
2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
time to maximum concentrations
Time Frame: 2 weeks
2 weeks
maximum concentration
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

St. Olavs Hospital
University of Iceland

Investigators

  • Study Director: Øyvind Ellingsen, MD PhD, Norwegian University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (ACTUAL)

October 1, 2014

Study Completion (ACTUAL)

November 1, 2014

Study Registration Dates

First Submitted

September 2, 2013

First Submitted That Met QC Criteria

September 5, 2013

First Posted (ESTIMATE)

September 11, 2013

Study Record Updates

Last Update Posted (ACTUAL)

November 3, 2021

Last Update Submitted That Met QC Criteria

October 27, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPI-12-001
  • 2012-004989-18 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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