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    Clinical Trial Results:
    Pharmacokinetic profile and pharmacodynamic effects after intranasal naloxone administration in volunteers.

    Summary
    EudraCT number
    		 2013-005201-31
    Trial protocol
    		 SE  
    Global end of trial date
    09 Jan 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Mar 2020
    First version publication date
    09 Mar 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    INNalox-1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Stockholm Läns Landsting
    Sponsor organisation address
    Karolinska Hospital, Stockholm, Sweden, 17176
    Public contact
    Stefan Lundeberg, Pain Tretament Service, Astrid Lindgren Children's Hospital, +46 851777271, stefan.lundeberg@karolinska.se
    Scientific contact
    Stefan Lundeberg, Pain Tretament Service, Astrid Lindgren Children's Hospital, +46 851777271, stefan.lundeberg@karolinska.se
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    09 Jan 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Jan 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Jan 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To study the pharmacokinetic profile in plasma after naloxone administered intranasally in healthy volunteers. Study the effect on sedation of oipioid after administration of the antidote naloxone
    Protection of trial subjects
    The nasal spray was tested before the study to find out any pain or discomfort on administration. Any pharmacodynamic effects not expected because no opioid was administrated before the test drug.
    Background therapy
    		 There was no background therapy or ongoing medication among the test subjects enrolled in this study
    Evidence for comparator
    		 n/a
    Actual start date of recruitment
    09 Feb 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Sweden: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    20
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Healthy volunteers from 18-64 years of age

    Pre-assignment
    Screening details
    		 Medical history was checked before enrollment

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    n/a

    Arms
    Arm title
    		 Intranasal naloxone
    Arm description
    		 Single group of healthy volunteers
    Arm type
    		 Experimental

    Investigational medicinal product name
    Naloxone hydrochlorid 0.4 mg/ml
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Intranasal use
    Dosage and administration details
    10 microgram per kg of naloxonehydrocloride was given as a spray. The injectable solution of 0.4 mg/ml was used.

    Number of subjects in period 1
    		Intranasal naloxone
    Started
    20
    Completed
    20

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Intranasal naloxone
    Reporting group description
    		 Single group of healthy volunteers

    Reporting group values
    		 Intranasal naloxone Total
    Number of subjects
    		 20 20
    Age categorical
    Volunteers for 18-64 years
    Units: Subjects
        Adults (18-64 years)
    		 20 20
    Age continuous
    healthy volunteers
    Units: years
        arithmetic mean (full range (min-max))
    		 37 (22 to 64) -
    Gender categorical
    Units: Subjects
        Female
    		 6 6
        Male
    		 14 14
    Adults
    helathy volunteers
    Units: Subjects
        volunteers
    		 20 20

    End points

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    End points reporting groups
    Reporting group title
    Intranasal naloxone
    Reporting group description
    		 Single group of healthy volunteers

    Primary: Naloxone concentration in plasma

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    End point title
    		 Naloxone concentration in plasma [1]
    End point description
    End point type
    Primary
    End point timeframe
    At the time of analysis of plasma samples were completed and kinetic parameters calculated.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No comparisons between groups. Descriptive analysis performed.
    End point values
    		 Intranasal naloxone
    Number of subjects analysed
    20
    Units: ng/ml
        number (not applicable)
    20
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    During and after administration of the single dose given intra-nasally and up to 24 hours after administration
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Study CRF
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Intranasal naloxone
    Reporting group description
    		 20 healthy volunteers

    Serious adverse events
    		 Intranasal naloxone
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Intranasal naloxone
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: There were no adverse effects. No discomfort or pain was noted in any subject as also noted in the clinical setting when naloxone is administered in patients.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The number of subjects studied (20) could to some extent be considered as a limitation. Although the number included is often used in similar studies.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/28444856
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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