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    Clinical Trial Results:
    STUDY TO EVALUATE THE PROPORTIONALITY OF 3 ORAL DOSES OF PIRLINDOLE IN HEALTHY VOLUNTEERS.

    Summary
    EudraCT number
    2012-003090-26
    Trial protocol
    ES  
    Global end of trial date
    02 May 2013

    Results information
    Results version number
    v1(current)
    This version publication date
    08 Aug 2020
    First version publication date
    08 Aug 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    110401
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Tecnimede, Sociedade Técnico-Medicinal, S.A.
    Sponsor organisation address
    Zona Industrial da Abrunheira, R. da Tapada Grande, nº 2, Sintra, Portugal, 2710-089
    Public contact
    SPONSOR'S REPRESENTATIVE, Tecnimede, Sociedade Técnico-Medicinal, S.A., +351 210414187, dmed.ct@tecnimede.pt
    Scientific contact
    SPONSOR'S REPRESENTATIVE, Tecnimede, Sociedade Técnico-Medicinal, S.A., +351 210414187, dmed.ct@tecnimede.pt
    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
    02 May 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 May 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    02 May 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Main objective is to assess the proportionality of 3 pirlindole doses (50, 100 and 150 mg) administered orally in healthy volunteers.
    Protection of trial subjects
    The study was conducted following the international recommendations for clinical research gathered in the declaration of Helsinki and its updating (revised in Tokyo 1975, Venice 1983, Hong Kong 1989, Sommerset West 1996, Edinburgh 2000, Washington 2002 and Seoul, South Korea 2008) and following the ICH Harmonized tripartite Guidelines for Good Clinical Practice (CPMP/ICH/135/95), guidelines of the Spanish Ministry of Health (Spanish Real Decret 223/2004) as well as the Directive 2001/20/EC (Note for Guidance “Good Clinical Practice for Studies on Medicinal Products in the European Community”).
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    10 Apr 2013
    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
    Spain: 18
    Worldwide total number of subjects
    18
    EEA total number of subjects
    18
    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)
    18
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Study participants were selected from the panel of volunteers at the Centre d’ Investigació de Medicaments CIM-Sant Pau. The beginning of the study (“first subject in") was on 29 April 2013.

    Pre-assignment
    Screening details
    The screening was performed during the four weeks and the final evaluation was carried out the day after the administration of the medication. During the screening period (four weeks before the randomization) all participants gave their informed consent and underwent a screening check-up to verify that they met the inclusion/exclusion criteria.

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Pirlindole 50 mg
    Arm description
    All participants who received Pirlindole (50mg) and who were not excluded from the pharmacokinetic population.
    Arm type
    Experimental

    Investigational medicinal product name
    Pirlindole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One single oral dose of Pirlindole 50 mg (one tablet of 50mg) was administered under fasting conditions. The medication was administrated with 240 ml of water.

    Arm title
    Pirlindole 100 mg
    Arm description
    All participants who received Pirlindole (100 mg) and who were not excluded from the pharmacokinetic population.
    Arm type
    Experimental

    Investigational medicinal product name
    Pirlindole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One single oral dose of Pirlindole 100 mg (two tablets of 50mg) was administered under fasting conditions. The medication was administrated with 240 ml of water.

    Arm title
    Pirlindole 150 mg
    Arm description
    All participants who received Pirlindole (150 mg) and who were not excluded from the pharmacokinetic population.
    Arm type
    Experimental

    Investigational medicinal product name
    Pirlindole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One single oral dose of Pirlindole 150 mg (three tablets of 50mg) was administered under fasting conditions. The medication was administrated with 240 ml of water.

    Number of subjects in period 1
    Pirlindole 50 mg Pirlindole 100 mg Pirlindole 150 mg
    Started
    6
    6
    6
    Completed
    6
    6
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall period
    Reporting group description
    -

    Reporting group values
    Overall period Total
    Number of subjects
    18 18
    Age categorical
    Units: Subjects
        In utero
    0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    0 0
        Infants and toddlers (28 days-23 months)
    0 0
        Children (2-11 years)
    0 0
        Adolescents (12-17 years)
    0 0
        Adults (18-64 years)
    18 18
        From 65-84 years
    0 0
        85 years and over
    0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    27.39 ± 7.55 -
    Gender categorical
    Units: Subjects
        Female
    9 9
        Male
    9 9
    Body weight
    Units: Kg
        arithmetic mean (standard deviation)
    66.57 ± 8.78 -
    Height
    Units: cm
        arithmetic mean (standard deviation)
    168.33 ± 6.31 -
    BMI: Quetelet’s index
    Units: kg/m2
        arithmetic mean (standard deviation)
    23.45 ± 2.52 -

    End points

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    End points reporting groups
    Reporting group title
    Pirlindole 50 mg
    Reporting group description
    All participants who received Pirlindole (50mg) and who were not excluded from the pharmacokinetic population.

    Reporting group title
    Pirlindole 100 mg
    Reporting group description
    All participants who received Pirlindole (100 mg) and who were not excluded from the pharmacokinetic population.

    Reporting group title
    Pirlindole 150 mg
    Reporting group description
    All participants who received Pirlindole (150 mg) and who were not excluded from the pharmacokinetic population.

    Primary: Area under the plasma concentration curve (AUC) from time 0 to last observed concentration of Pirlindole

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    End point title
    Area under the plasma concentration curve (AUC) from time 0 to last observed concentration of Pirlindole
    End point description
    End point type
    Primary
    End point timeframe
    Baseline (pre-dose), +10 min, +20 min, +30 min, +45 min, +1 h, +1h15 min, +1h30min, +1h45min, +2h, +3h, +5h, +6h, +8h, +12h and +24h post-dose.
    End point values
    Pirlindole 50 mg Pirlindole 100 mg Pirlindole 150 mg
    Number of subjects analysed
    6
    6
    6
    Units: ng.h/mL
        arithmetic mean (standard deviation)
    55.84 ± 27.77
    301.62 ± 279.55
    370.23 ± 225.77
    Statistical analysis title
    Linear regression analysis
    Comparison groups
    Pirlindole 50 mg v Pirlindole 100 mg v Pirlindole 150 mg
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Regression, Linear
    Parameter type
    Coefficient of the regression line
    Point estimate
    1.715
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.976
         upper limit
    2.453

    Primary: Maximum concentration (Cmax) in plasma of Pirlindole

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    End point title
    Maximum concentration (Cmax) in plasma of Pirlindole
    End point description
    End point type
    Primary
    End point timeframe
    Baseline (pre-dose), +10 min, +20 min, +30 min, +45 min, +1 h, +1h15 min, +1h30min, +1h45min, +2h, +3h, +5h, +6h, +8h, +12h and +24h post-dose.
    End point values
    Pirlindole 50 mg Pirlindole 100 mg Pirlindole 150 mg
    Number of subjects analysed
    6
    6
    6
    Units: ng/mL
        arithmetic mean (standard deviation)
    29.84 ± 16.46
    96.37 ± 65.18
    123.56 ± 62.71
    Statistical analysis title
    Linear regression analysis
    Comparison groups
    Pirlindole 50 mg v Pirlindole 100 mg v Pirlindole 150 mg
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Regression, Linear
    Parameter type
    Coefficient of the regression line
    Point estimate
    1.339
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.77
         upper limit
    1.908

    Primary: Area under the concentration-time curve from time 0 to infinity (AUC0-inf) in plasma of Pirlindole

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    End point title
    Area under the concentration-time curve from time 0 to infinity (AUC0-inf) in plasma of Pirlindole
    End point description
    End point type
    Primary
    End point timeframe
    Baseline (pre-dose), +10 min, +20 min, +30 min, +45 min, +1 h, +1h15 min, +1h30min, +1h45min, +2h, +3h, +5h, +6h, +8h, +12h and +24h post-dose.
    End point values
    Pirlindole 50 mg Pirlindole 100 mg Pirlindole 150 mg
    Number of subjects analysed
    6
    6
    6
    Units: ng.h/mL
        arithmetic mean (standard deviation)
    59.27 ± 30.74
    313.12 ± 292.99
    384.71 ± 239.73
    Statistical analysis title
    Linear regression analysis
    Comparison groups
    Pirlindole 50 mg v Pirlindole 100 mg v Pirlindole 150 mg
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Regression, Linear
    Parameter type
    Coefficient of the regression line
    Point estimate
    1.697
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.95
         upper limit
    2.443

    Secondary: Elimination rate constant (Kel) of Pirlindole

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    End point title
    Elimination rate constant (Kel) of Pirlindole
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline (pre-dose), +10 min, +20 min, +30 min, +45 min, +1 h, +1h15 min, +1h30min, +1h45min, +2h, +3h, +5h, +6h, +8h, +12h and +24h post-dose.
    End point values
    Pirlindole 50 mg Pirlindole 100 mg Pirlindole 150 mg
    Number of subjects analysed
    6
    6
    6
    Units: 1/h
        arithmetic mean (standard deviation)
    0.37 ± 0.23
    0.25 ± 0.15
    0.18 ± 0.06
    No statistical analyses for this end point

    Secondary: Elimination half-life (T ½) of Pirlindole

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    End point title
    Elimination half-life (T ½) of Pirlindole
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline (pre-dose), +10 min, +20 min, +30 min, +45 min, +1 h, +1h15 min, +1h30min, +1h45min, +2h, +3h, +5h, +6h, +8h, +12h and +24h post-dose.
    End point values
    Pirlindole 50 mg Pirlindole 100 mg Pirlindole 150 mg
    Number of subjects analysed
    6
    6
    6
    Units: hour
        median (full range (min-max))
    2.63 (1.05 to 4.79)
    3.75 (1.43 to 6.16)
    3.90 (2.81 to 7.28)
    No statistical analyses for this end point

    Secondary: Apparent volume of distribution estimated from extravascular route (Vd/F) of Pirlindole

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    End point title
    Apparent volume of distribution estimated from extravascular route (Vd/F) of Pirlindole
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline (pre-dose), +10 min, +20 min, +30 min, +45 min, +1 h, +1h15 min, +1h30min, +1h45min, +2h, +3h, +5h, +6h, +8h, +12h and +24h post-dose.
    End point values
    Pirlindole 50 mg Pirlindole 100 mg Pirlindole 150 mg
    Number of subjects analysed
    6
    6
    6
    Units: litre(s)
        arithmetic mean (standard deviation)
    3133.18 ± 1068.80
    2288.59 ± 719.24
    2729.25 ± 785.49
    No statistical analyses for this end point

    Secondary: Total body clearance estimated from extravascular route (Cl/F) of Pirlindole

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    End point title
    Total body clearance estimated from extravascular route (Cl/F) of Pirlindole
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline (pre-dose), +10 min, +20 min, +30 min, +45 min, +1 h, +1h15 min, +1h30min, +1h45min, +2h, +3h, +5h, +6h, +8h, +12h and +24h post-dose.
    End point values
    Pirlindole 50 mg Pirlindole 100 mg Pirlindole 150 mg
    Number of subjects analysed
    6
    6
    6
    Units: L/h
        arithmetic mean (standard deviation)
    1014.28 ± 427.14
    612.39 ± 436.59
    517.96 ± 275.17
    No statistical analyses for this end point

    Secondary: Time to reach maximum (peak) plasma concentration (Tmax) of Pirlindole

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    End point title
    Time to reach maximum (peak) plasma concentration (Tmax) of Pirlindole
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline (pre-dose), +10 min, +20 min, +30 min, +45 min, +1 h, +1h15 min, +1h30min, +1h45min, +2h, +3h, +5h, +6h, +8h, +12h and +24h post-dose.
    End point values
    Pirlindole 50 mg Pirlindole 100 mg Pirlindole 150 mg
    Number of subjects analysed
    6
    6
    6
    Units: hour
        median (full range (min-max))
    0.75 (0.75 to 1.75)
    1.0 (0.75 to 1.75)
    1.25 (0.75 to 5.0)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV).
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Pirlindole 50 mg
    Reporting group description
    All participants who received Pirlindole (50mg) and who were not excluded from the pharmacokinetic population.

    Reporting group title
    Pirlindole 100 mg
    Reporting group description
    All participants who received Pirlindole (100 mg) and who were not excluded from the pharmacokinetic population.

    Reporting group title
    Pirlindole 150 mg
    Reporting group description
    All participants who received Pirlindole (150 mg) and who were not excluded from the pharmacokinetic population.

    Serious adverse events
    Pirlindole 50 mg Pirlindole 100 mg Pirlindole 150 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Pirlindole 50 mg Pirlindole 100 mg Pirlindole 150 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 6 (33.33%)
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 6 (33.33%)
    1 / 6 (16.67%)
    1 / 6 (16.67%)
         occurrences all number
    2
    1
    1

    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.
    None reported
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