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A Pilot Study of the Bioavailability of Nasal Naloxone

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE September 2, 2013
First Posted Date  ICMJE September 11, 2013
Last Update Posted Date January 5, 2015
Study Start Date  ICMJE August 2013
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01939444 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2013)
  • time to maximum concentrations [ Time Frame: 2 weeks ]
  • maximum concentration [ Time Frame: 2 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pilot Study of the Bioavailability of Nasal Naloxone
Official Title  ICMJE A Pilot Study of the Bioavailability of Nasal Naloxone
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Drug Overdose
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: naloxone intranasal
    2.0 mg by the nasal route
    Intervention: Drug: naloxone intranasal
  • Active Comparator: naloxone intravenous
    1.0 mg intravenous
    Intervention: Drug: naloxone intravenous
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 5, 2013)
5
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01939444
Other Study ID Numbers  ICMJE OPI-12-001
2012-004989-18 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Norwegian University of Science and Technology
Study Sponsor  ICMJE Norwegian University of Science and Technology
Collaborators  ICMJE
  • St. Olavs Hospital
  • University of Iceland
Investigators  ICMJE
Study Director: Øyvind Ellingsen, MD PhD Norwegian University of Science and Technology
PRS Account Norwegian University of Science and Technology
Verification Date January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP