Back to resultsA Pilot Study of the Bioavailability of Nasal Naloxone
Primary Purpose
Drug Overdose
Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
naloxone intranasal
naloxone intravenous
Sponsored by
About this trial
This is an interventional basic science trial for Drug Overdose focused on measuring Antidotes, naloxone, administration, intravenous, administration, intranasal, pharmacology
Eligibility Criteria
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
Sites / Locations
- Department of circulation and medical imaging, NTNU
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
naloxone intranasal
naloxone intravenous
Arm Description
2.0 mg by the nasal route
1.0 mg intravenous
Outcomes
Primary Outcome Measures
preliminary bioavailability of nasal naloxone
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.
Secondary Outcome Measures
time to maximum concentrations
maximum concentration
Full Information
NCT ID
NCT01939444
First Posted
September 2, 2013
Last Updated
October 27, 2021
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital, University of Iceland
1. Study Identification
Unique Protocol Identification Number
NCT01939444
Brief Title
A Pilot Study of the Bioavailability of Nasal Naloxone
Official Title
A Pilot Study of the Bioavailability of Nasal Naloxone
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital, University of Iceland
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Overdose
Keywords
Antidotes, naloxone, administration, intravenous, administration, intranasal, pharmacology
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
naloxone intranasal
Arm Type
Experimental
Arm Description
2.0 mg by the nasal route
Arm Title
naloxone intravenous
Arm Type
Active Comparator
Arm Description
1.0 mg intravenous
Intervention Type
Drug
Intervention Name(s)
naloxone intranasal
Intervention Description
If bioavailability is 20% or 50 %, the dose will be equivalent to the clinical range 0.4 - 1.0 mg given parenterally
Intervention Type
Drug
Intervention Name(s)
naloxone intravenous
Intervention Description
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
Primary Outcome Measure Information:
Title
preliminary bioavailability of nasal naloxone
Description
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.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
time to maximum concentrations
Time Frame
2 weeks
Title
maximum concentration
Time Frame
2 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Øyvind Ellingsen, MD PhD
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
Department of circulation and medical imaging, NTNU
City
Trondheim
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
31556537
Citation
Tylleskar I, Skulberg AK, Nilsen T, Skarra S, Dale O. Naloxone nasal spray - bioavailability and absorption pattern in a phase 1 study. Tidsskr Nor Laegeforen. 2019 Sep 23;139(13). doi: 10.4045/tidsskr.19.0162. Print 2019 Sep 24. English, Norwegian.
Results Reference
result
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A Pilot Study of the Bioavailability of Nasal Naloxone
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