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A Pilot Study of the Bioavailability of Nasal Naloxone

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ClinicalTrials.gov Identifier: NCT01939444
Recruitment Status : Completed
First Posted : September 11, 2013
Last Update Posted : January 5, 2015
Sponsor:
Collaborators:
St. Olavs Hospital
University of Iceland
Information provided by (Responsible Party):
Norwegian University of Science and Technology

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

Condition or disease Intervention/treatment Phase
Drug Overdose Drug: naloxone intranasal Drug: naloxone intravenous Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Pilot Study of the Bioavailability of Nasal Naloxone
Study Start Date : August 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. time to maximum concentrations [ Time Frame: 2 weeks ]
  2. maximum concentration [ Time Frame: 2 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01939444


Locations
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Norway
Department of circulation and medical imaging, NTNU
Trondheim, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
University of Iceland
Investigators
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Study Director: Øyvind Ellingsen, MD PhD Norwegian University of Science and Technology

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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01939444     History of Changes
Other Study ID Numbers: OPI-12-001
2012-004989-18 ( EudraCT Number )
First Posted: September 11, 2013    Key Record Dates
Last Update Posted: January 5, 2015
Last Verified: January 2015

Keywords provided by Norwegian University of Science and Technology:
Antidotes
naloxone
administration, intravenous
administration, intranasal
pharmacology

Additional relevant MeSH terms:
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Drug Overdose
Substance-Related Disorders
Chemically-Induced Disorders
Naloxone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents