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    Clinical Trial Results:
    A PHASE 1, OPEN-LABEL STUDY OF LATANOPROST ACID PLASMA CONCENTRATIONS IN PEDIATRIC AND ADULT GLAUCOMA SUBJECTS TREATED WITH LATANOPROST 0.005%

    Summary
    EudraCT number
    		 2008-000844-15
    Trial protocol
    		 GB   ES   PT   DK   PL   IT   GR   Outside EU/EEA  
    Global end of trial date
    26 Mar 2009

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Jun 2016
    First version publication date
    06 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    A6111139
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00638742
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer Inc., Pfizer ClinicalTrials.gov Call Center, 001 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer Inc., Pfizer ClinicalTrials.gov Call Center, 001 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000011-PIP01-07
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    23 Sep 2009
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Mar 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the steady-state systemic plasma concentrations of latanoprost acid following administration of latanoprost 0.005 percent (%) (1.5 microgram[mcg]) in pediatric and adult subjects with glaucoma or ocular hypertension.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial participants were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 May 2008
    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
    Portugal: 3
    Country: Number of subjects enrolled
    Spain: 3
    Country: Number of subjects enrolled
    Denmark: 1
    Country: Number of subjects enrolled
    Italy: 6
    Country: Number of subjects enrolled
    United States: 31
    Country: Number of subjects enrolled
    South Africa: 3
    Worldwide total number of subjects
    47
    EEA total number of subjects
    13
    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)
    7
    Children (2-11 years)
    11
    Adolescents (12-17 years)
    7
    Adults (18-64 years)
    12
    From 65 to 84 years
    8
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The study was conducted at 12 centers in 6 countries between 19 May 2008 to 26 March 2009.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Latanoprost (0 to less than [<] 3 Years)
    Arm description
    		 Subjects aged less than 3 years received latanoprost 0.005% in either one or both eyes.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Latanoprost
    Investigational medicinal product code
    Other name
    Xalatan
    Pharmaceutical forms
    Eye drops, solution
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    One drop (1.5 mcg) of 0.005% latanoprost daily in either one or both eyes for at least 2 weeks.

    Arm title
    		 Latanoprost (3 to < 12 years)
    Arm description
    		 Subjects aged 3 to < 12 years received latanoprost 0.005% in either one or both eyes.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Latanoprost
    Investigational medicinal product code
    Other name
    Xalatan
    Pharmaceutical forms
    Eye drops, solution
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    One drop (1.5 mcg) of 0.005% latanoprost daily in either one or both eyes for at least 2 weeks.

    Arm title
    		 Latanoprost (12 to < 18 years)
    Arm description
    		 Subjects aged from 12 to < 18 years recieved latanoprost 0.005% daily in either one or both eyes.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Latanoprost
    Investigational medicinal product code
    Other name
    Xalatan
    Pharmaceutical forms
    Eye drops, solution
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    One drop (1.5 mcg) of 0.005% latanoprost daily in either one or both eyes for at least 2 weeks.

    Arm title
    		 Latanoprost (greater than or equal to [≥] 18 years)
    Arm description
    		 Subjects aged ≥ 18 years recieved latanoprost 0.005% daily in either one or both eyes.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Latanoprost
    Investigational medicinal product code
    Other name
    Xalatan
    Pharmaceutical forms
    Eye drops, solution
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    One drop (1.5 mcg) of 0.005% latanoprost daily in either one or both eyes for at least 2 weeks.

    Number of subjects in period 1
    		Latanoprost (0 to less than [<] 3 Years) Latanoprost (3 to < 12 years) Latanoprost (12 to < 18 years) Latanoprost (greater than or equal to [≥] 18 years)
    Started
    8
    10
    7
    22
    Completed
    7
    10
    7
    22
    Not completed
    1
    0
    0
    0
         Protocol Violation
    1
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Latanoprost (0 to less than [<] 3 Years)
    Reporting group description
    		 Subjects aged less than 3 years received latanoprost 0.005% in either one or both eyes.

    Reporting group title
    Latanoprost (3 to < 12 years)
    Reporting group description
    		 Subjects aged 3 to < 12 years received latanoprost 0.005% in either one or both eyes.

    Reporting group title
    Latanoprost (12 to < 18 years)
    Reporting group description
    		 Subjects aged from 12 to < 18 years recieved latanoprost 0.005% daily in either one or both eyes.

    Reporting group title
    Latanoprost (greater than or equal to [≥] 18 years)
    Reporting group description
    		 Subjects aged ≥ 18 years recieved latanoprost 0.005% daily in either one or both eyes.

    Reporting group values
    		 Latanoprost (0 to less than [<] 3 Years) Latanoprost (3 to < 12 years) Latanoprost (12 to < 18 years) Latanoprost (greater than or equal to [≥] 18 years) Total
    Number of subjects
    		 8 10 7 22 47
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 1.3 ( 0.7 ) 8.7 ( 1.9 ) 13.6 ( 1.4 ) 62.8 ( 13.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 1 7 3 12 23
        Male
    		 7 3 4 10 24

    End points

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    End points reporting groups
    Reporting group title
    Latanoprost (0 to less than [<] 3 Years)
    Reporting group description
    		 Subjects aged less than 3 years received latanoprost 0.005% in either one or both eyes.

    Reporting group title
    Latanoprost (3 to < 12 years)
    Reporting group description
    		 Subjects aged 3 to < 12 years received latanoprost 0.005% in either one or both eyes.

    Reporting group title
    Latanoprost (12 to < 18 years)
    Reporting group description
    		 Subjects aged from 12 to < 18 years recieved latanoprost 0.005% daily in either one or both eyes.

    Reporting group title
    Latanoprost (greater than or equal to [≥] 18 years)
    Reporting group description
    		 Subjects aged ≥ 18 years recieved latanoprost 0.005% daily in either one or both eyes.

    Primary: Maximum Observed Plasma Concentration (Cmax)

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    End point title
    		 Maximum Observed Plasma Concentration (Cmax) [1]
    End point description
    Subjects analysed for the endpoint are those included in the Evaluable Pharmacokinetic Analysis set. Evaluable PK analyis set included all enrolled subjects who were treated, had at least 1 quantifiable concentration and without major protocol deviation.
    End point type
    Primary
    End point timeframe
    pre-dose, 5, 15, 30, 60 minutes post-dose
    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: Only descriptive data was planned for this endpoint.
    End point values
    		 Latanoprost (0 to less than [<] 3 Years) Latanoprost (3 to < 12 years) Latanoprost (12 to < 18 years) Latanoprost (greater than or equal to [≥] 18 years)
    Number of subjects analysed
    7
    9
    6
    17
    Units: picogram/milliliter
        arithmetic mean (standard deviation)
    140.41 ( 63.941 )
    67.51 ( 54.612 )
    24.32 ( 15.752 )
    29.19 ( 12.635 )
    No statistical analyses for this end point

    Primary: Time to Reach Maximum Observed Plasma Concentration (Tmax)

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    End point title
    		 Time to Reach Maximum Observed Plasma Concentration (Tmax) [2]
    End point description
    Subjects analysed for the endpoint are those included in the Evaluable Pharmacokinetic Analysis set. Evaluable PK analyis set included all enrolled subjects who were treated, had at least 1 quantifiable concentration and without major protocol deviation.
    End point type
    Primary
    End point timeframe
    pre-dose, 5, 15, 30, 60 minutes post-dose
    Notes
    [2] - 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: Only descriptive data was planned for this endpoint.
    End point values
    		 Latanoprost (0 to less than [<] 3 Years) Latanoprost (3 to < 12 years) Latanoprost (12 to < 18 years) Latanoprost (greater than or equal to [≥] 18 years)
    Number of subjects analysed
    7
    9
    6
    17
    Units: minutes
        median (full range (min-max))
    5 (5 to 15)
    5 (5 to 5)
    5 (5 to 5)
    5 (4 to 18)
    No statistical analyses for this end point

    Primary: Plasma Elimination Half-Life (t1/2)

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    End point title
    		 Plasma Elimination Half-Life (t1/2) [3]
    End point description
    Plasma decay half-life is the time calculated for the plasma concentration to decrease by one half. Subjects analysed for the endpoint are those included in the Evaluable Pharmacokinetic Analysis set. Evaluable PK analyis set included all enrolled subjects who were treated, had at least 1 quantifiable concentration and without major protocol deviation.
    End point type
    Primary
    End point timeframe
    Pre-dose, 5, 15, 30, 60 minutes post-dose
    Notes
    [3] - 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: Only descriptive data was planned for this endpoint.
    End point values
    		 Latanoprost (0 to less than [<] 3 Years) Latanoprost (3 to < 12 years) Latanoprost (12 to < 18 years) Latanoprost (greater than or equal to [≥] 18 years)
    Number of subjects analysed
    5 [4]
    5 [5]
    0 [6]
    4 [7]
    Units: minutes
        arithmetic mean (standard deviation)
    20.058 ( 4.7892 )
    11.993 ( 3.4536 )
    ( )
    20.511 ( 7.1454 )
    Notes
    [4] - Number of subjects analysed for this endpoint.
    [5] - Number of subjects analysed for this endpoint.
    [6] - None of the subjects had sufficient data to characterize the terminal elimination phase.
    [7] - Number of subjects analysed for this endpoint.
    No statistical analyses for this end point

    Primary: Systemic Clearance (CL/F)

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    End point title
    		 Systemic Clearance (CL/F) [8]
    End point description
    Clearance of a drug is a measure of the rate at which a drug is removed from the body. Evaluable Pharmacokinetic Analysis Set include all enrolled subjects who are treated, have at least 1 quantifiable concentration and without major protocol deviation.
    End point type
    Primary
    End point timeframe
    Pre-dose, 5, 15, 30, 60 minutes post-dose
    Notes
    [8] - 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: Only descriptive data was planned for this endpoint.
    End point values
    		 Latanoprost (0 to less than [<] 3 Years) Latanoprost (3 to < 12 years) Latanoprost (12 to < 18 years) Latanoprost (greater than or equal to [≥] 18 years)
    Number of subjects analysed
    5 [9]
    5 [10]
    0 [11]
    3 [12]
    Units: milliliter/minutes (mL/min)
        arithmetic mean (standard deviation)
    730 ( 298.98 )
    2093.9 ( 965.05 )
    ( )
    2168.9 ( 530.1 )
    Notes
    [9] - Number of subjects analysed for this endpoint.
    [10] - Number of subjects analysed for this endpoint.
    [11] - None of the subjects had sufficient data to characterize the terminal elimination phase.
    [12] - Number of subjects analysed for this endpoint.
    No statistical analyses for this end point

    Primary: Apparent Volume of Distribution ((Vz/F)

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    End point title
    		 Apparent Volume of Distribution ((Vz/F) [13]
    End point description
    Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Subjects analysed for the endpoint are those included in the Evaluable Pharmacokinetic Analysis set. Evaluable PK analyis set included all enrolled subjects who were treated, had at least 1 quantifiable concentration and without major protocol deviation.
    End point type
    Primary
    End point timeframe
    Pre-dose, 5, 15, 30, 60 mintues post-dose
    Notes
    [13] - 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: Only descriptive data was planned for this endpoint.
    End point values
    		 Latanoprost (0 to less than [<] 3 Years) Latanoprost (3 to < 12 years) Latanoprost (12 to < 18 years) Latanoprost (greater than or equal to [≥] 18 years)
    Number of subjects analysed
    5 [14]
    5 [15]
    0 [16]
    3 [17]
    Units: liter
        arithmetic mean (standard deviation)
    22.26 ( 14.927 )
    39.84 ( 29.258 )
    ( )
    52.32 ( 6.328 )
    Notes
    [14] - Number of subjects analysed for this endpoint.
    [15] - Number of subjects analysed for this endpoint.
    [16] - None of the subjects had sufficient data to characterize the terminal elimination phase.
    [17] - Number of subjects analysed for this endpoint.
    No statistical analyses for this end point

    Secondary: Number of Participants With Adverse Events Related to Systemic Exposure of Latanoprost

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    End point title
    		 Number of Participants With Adverse Events Related to Systemic Exposure of Latanoprost
    End point description
    An adverse event is any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Safety Analysis Set: All subjects who receive at least 1 dose of study medication.
    End point type
    Secondary
    End point timeframe
    Baseline up to 28 days after last dose of study drug.
    End point values
    		 Latanoprost (0 to less than [<] 3 Years) Latanoprost (3 to < 12 years) Latanoprost (12 to < 18 years) Latanoprost (greater than or equal to [≥] 18 years)
    Number of subjects analysed
    8
    10
    7
    22
    Units: subjects
    0
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Baseline up to 28 days after last dose of study drug.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.0
    Reporting groups
    Reporting group title
    Latanoprost (0 to less than [<] 3 Years)
    Reporting group description
    		 Subjects with age less than 3 years recieved Latanoprost 0.005% daily in either one or both eyes.

    Reporting group title
    Latanoprost ( 3 to < 12 years)
    Reporting group description
    		 Subjects with age from 3 to < 12 years recieved latanoprost 0.005% daily in either one or both eyes.

    Reporting group title
    Latanoprost (12 to < 18 years)
    Reporting group description
    		 Subjects from 12 to < 18 years of age recieved latanoprost 0.005% daily in either one or both eyes.

    Reporting group title
    Latanoprost (greater than or equal to [≥]18 years
    Reporting group description
    		 Subjects with age ≥ 18 years recieved latanoprost 0.005% daily in either one or both eyes.

    Serious adverse events
    		 Latanoprost (0 to less than [<] 3 Years) Latanoprost ( 3 to < 12 years) Latanoprost (12 to < 18 years) Latanoprost (greater than or equal to [≥]18 years
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 22 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Latanoprost (0 to less than [<] 3 Years) Latanoprost ( 3 to < 12 years) Latanoprost (12 to < 18 years) Latanoprost (greater than or equal to [≥]18 years
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 22 (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: No non-serious adverse events were reported during the study.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Mar 2008
    1. Total blood sampling volume for adult patients ≥18 years of age changed from 32 mL to approximately 64 mL. 2. Clinical laboratory, blood pressure, and pulse rate abnormalities of potential clinical concern were evaluated in addition to other evaluations. 3. Females of childbearing potential (post-menarchal females) must have a negative urine pregnancy test at screening or on the study day (prior to dosing). 4. Sampling was not acceptable method of blood collection for either the safety labs or pharmacokinetic samples due to the risk of hemolysis, heel or scalp. 5. Results of the pharmacokinetic data from the older pediatric group (12 to <18 years old) were examined before proceeding to the 2nd age group (3 to <12 years olds) and were re-evaluated before enrolling the youngest age group (0 to <3 years).

    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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