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    Clinical Trial Results:
    A Pharmacokinetic Analysis of Posaconazole in the Plasma and Alveolar Compartment of Lung Transplant Recipients (PAPAL)

    Summary
    EudraCT number
    		 2012-003140-68
    Trial protocol
    		 GB  
    Global end of trial date
    16 Jan 2014

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

    Trial information

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    Trial identification
    Sponsor protocol code
    MK-5592-105
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01667107
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    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
    16 Jan 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Jan 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Jan 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    This single site study will examine plasma and alveolar compartment levels of posaconazole in cystic fibrosis and non-cystic fibrosis lung transplant recipients receiving routine post-operative anti-fungal prophylaxis. Invasive fungal infection rates will be assessed following transplantation.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Jan 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
    United Kingdom: 26
    Worldwide total number of subjects
    26
    EEA total number of subjects
    26
    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)
    24
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 All participants were scheduled to undergo lung transplantation. Participants with severe liver disease or receiving cytochrome P-450 (CYP)-3A4 inhibitors were excluded. Other inclusion and exclusion criteria applied.

    Pre-assignment
    Screening details
    		 There were no screening failures for cystic fibrosis participants and one for non-cystic fibrosis participants.

    Period 1
    Period 1 title
    Posaconazole Treatment (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cystic Fibrosis Participants
    Arm description
    		 Posaconazole 400 mg oral solution twice daily administered with Calogen® 30 mL oral emulsion (administered before the posaconazole to optimize absorption) for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day and Calogen® 15 mL if the participant was unable to meet the conditions for optimal absorption of posaconazole.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Posaconazole
    Investigational medicinal product code
    Other name
    MK-5592, Noxafil®
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Posaconazole 400 mg oral solution twice daily administered with Calogen® 30 mL oral emulsion (administered before the posaconazole to optimize absorption) for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day and Calogen® 15 mL if the participant was unable to meet the conditions for optimal absorption of posaconazole.

    Investigational medicinal product name
    Calogen®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral emulsion
    Routes of administration
    Oral use
    Dosage and administration details
    Posaconazole 400 mg oral solution twice daily administered with Calogen® 30 mL oral emulsion (administered before the posaconazole to optimize absorption) for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day and Calogen® 15 mL if the participant was unable to meet the conditions for optimal absorption of posaconazole.

    Arm title
    		 Non-cystic Fibrosis Participants
    Arm description
    		 Posaconazole 400 mg oral solution twice daily administered with Calogen® 30 mL oral emulsion (administered before the posaconazole to optimize absorption) for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day and Calogen® 15 mL if the participant was unable to meet the conditions for optimal absorption of posaconazole.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Posaconazole
    Investigational medicinal product code
    Other name
    MK-5592, Noxafil®
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Posaconazole 400 mg oral solution twice daily administered with Calogen® 30 mL oral emulsion (administered before the posaconazole to optimize absorption) for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day and Calogen® 15 mL if the participant was unable to meet the conditions for optimal absorption of posaconazole.

    Investigational medicinal product name
    Calogen®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral emulsion
    Routes of administration
    Oral use
    Dosage and administration details
    Posaconazole 400 mg oral solution twice daily administered with Calogen® 30 mL oral emulsion (administered before the posaconazole to optimize absorption) for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day and Calogen® 15 mL if the participant was unable to meet the conditions for optimal absorption of posaconazole.

    Number of subjects in period 1
    		Cystic Fibrosis Participants Non-cystic Fibrosis Participants
    Started
    8
    18
    Completed
    4
    11
    Not completed
    4
    7
         Adverse event, non-fatal
    4
    3
         Tolerability issues
    -
    2
         Protocol deviation
    -
    1
         Lack of efficacy
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cystic Fibrosis Participants
    Reporting group description
    		 Posaconazole 400 mg oral solution twice daily administered with Calogen® 30 mL oral emulsion (administered before the posaconazole to optimize absorption) for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day and Calogen® 15 mL if the participant was unable to meet the conditions for optimal absorption of posaconazole.

    Reporting group title
    Non-cystic Fibrosis Participants
    Reporting group description
    		 Posaconazole 400 mg oral solution twice daily administered with Calogen® 30 mL oral emulsion (administered before the posaconazole to optimize absorption) for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day and Calogen® 15 mL if the participant was unable to meet the conditions for optimal absorption of posaconazole.

    Reporting group values
    		 Cystic Fibrosis Participants Non-cystic Fibrosis Participants Total
    Number of subjects
    		 8 18 26
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 8 16 24
        From 65-84 years
    		 0 2 2
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 30 ( 7.82 ) 52.4 ( 10.39 ) -
    Gender categorical
    Units: Subjects
        Female
    		 5 7 12
        Male
    		 3 11 14

    End points

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    End points reporting groups
    Reporting group title
    Cystic Fibrosis Participants
    Reporting group description
    		 Posaconazole 400 mg oral solution twice daily administered with Calogen® 30 mL oral emulsion (administered before the posaconazole to optimize absorption) for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day and Calogen® 15 mL if the participant was unable to meet the conditions for optimal absorption of posaconazole.

    Reporting group title
    Non-cystic Fibrosis Participants
    Reporting group description
    		 Posaconazole 400 mg oral solution twice daily administered with Calogen® 30 mL oral emulsion (administered before the posaconazole to optimize absorption) for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day and Calogen® 15 mL if the participant was unable to meet the conditions for optimal absorption of posaconazole.

    Primary: Time to Reach 90% of the Steady State Serum Concentration of Posaconazole

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    End point title
    		 Time to Reach 90% of the Steady State Serum Concentration of Posaconazole [1]
    End point description
    Blood samples for measurement of serum posaconazole were collected approximately 4 hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43. The time to reach 90% of the steady state serum posaconazole concentration was to be estimated from fitting a linear model to the concentration data over time. The data did not permit estimation of the endpoint from the modeling proposed in the protocol.
    End point type
    Primary
    End point timeframe
    Four hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43
    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: The data did not permit estimation of the endpoint from the modeling proposed in the protocol
    End point values
    		 Cystic Fibrosis Participants Non-cystic Fibrosis Participants
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: Days
        number (not applicable)
    Notes
    [2] - The data did not permit estimation of the endpoint from the modeling proposed in the protocol
    [3] - The data did not permit estimation of the endpoint from the modeling proposed in the protocol
    No statistical analyses for this end point

    Primary: Concentration of Posaconazole in Bronchoalveolar Lavage (BAL) and Serum

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    End point title
    		 Concentration of Posaconazole in Bronchoalveolar Lavage (BAL) and Serum [4]
    End point description
    Concurrent BAL and serum samples for measurement of posaconazole concentration were to be collected during any clinically-indicated bronchoscopy. A participant could have more than 1 bronchoscopy. Spearman rank correlation coefficients between BAL and serum posaconazole concentrations were 0.53 (P-value 0.139) for cystic fibrosis participants and 0.057 (P-value 0.59) for non-cystic fibrosis participants.
    End point type
    Primary
    End point timeframe
    Up to Day 42
    Notes
    [4] - 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 between-group statistical analyses were planned for this endpoint
    End point values
    		 Cystic Fibrosis Participants Non-cystic Fibrosis Participants
    Number of subjects analysed
    5 [5]
    7 [6]
    Units: mg/L
    arithmetic mean (standard deviation)
        BAL
    1.116 ( 1.1699 )
    0.764 ( 0.8 )
        Serum
    0.829 ( 0.3742 )
    0.7488 ( 0.3131 )
    Notes
    [5] - The 5 participants had a total of 9 paired BAL and serum samples for analysis
    [6] - The 7 participants had a total of 11 paired BAL and serum samples for analysis
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Develop Invasive Fungal Infection

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    End point title
    		 Percentage of Participants Who Develop Invasive Fungal Infection
    End point description
    Invasive fungal infection was assessed using the Mycoses Study Group/European Organisation for Research and Treatment of Cancer (MSG/EORTC) criteria. Infections counted in the analysis were those classified as 'proven', 'probable', or 'possible' according to the criteria.
    End point type
    Secondary
    End point timeframe
    Up to Day 84
    End point values
    		 Cystic Fibrosis Participants Non-cystic Fibrosis Participants
    Number of subjects analysed
    8
    18
    Units: Percentage of participants
        number (confidence interval 95%)
    12.5 (2.2 to 47.1)
    16.7 (5.8 to 39.2)
    No statistical analyses for this end point

    Secondary: Time to Reach a Serum Concentration of Posaconazole of >=0.5 mg/L

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    End point title
    		 Time to Reach a Serum Concentration of Posaconazole of >=0.5 mg/L
    End point description
    Blood samples for measurement of serum concentration of posaconazole were collected approximately 4 hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43. A posaconazole concentration >=0.5 mg/L is the therapeutic level, the concentration thought to lead to antifungal efficacy. The time at which the serum posaconazole concentration reached >=0.5 mg/mL and remained at that level for all subsequent assessments was recorded.
    End point type
    Secondary
    End point timeframe
    Four hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43
    End point values
    		 Cystic Fibrosis Participants Non-cystic Fibrosis Participants
    Number of subjects analysed
    6 [7]
    14 [8]
    Units: Days
        arithmetic mean (standard deviation)
    12.2 ( 8.82 )
    11.9 ( 9.86 )
    Notes
    [7] - Participants who reached and maintained a posaconazole concentration >=0.5 mg/L
    [8] - Participants who reached and maintained a posaconazole concentration >=0.5 mg/L
    No statistical analyses for this end point

    Secondary: Maximum Serum Concentration of Posaconazole (Cmax)

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    End point title
    		 Maximum Serum Concentration of Posaconazole (Cmax)
    End point description
    Blood samples for measurement of serum concentration of posaconazole were collected approximately 4 hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43. The maximum serum concentration of posaconazole was recorded.
    End point type
    Secondary
    End point timeframe
    Four hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43
    End point values
    		 Cystic Fibrosis Participants Non-cystic Fibrosis Participants
    Number of subjects analysed
    8
    18
    Units: mg/L
        arithmetic mean (standard deviation)
    1.481 ( 0.6014 )
    1.539 ( 0.8471 )
    No statistical analyses for this end point

    Secondary: Time to Maximum Serum Concentration of Posaconazole (Tmax)

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    End point title
    		 Time to Maximum Serum Concentration of Posaconazole (Tmax)
    End point description
    Blood samples for measurement of serum concentration of posaconazole were collected approximately 4 hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43. The time required to achieve the maximum serum concentration of posaconazole was recorded.
    End point type
    Secondary
    End point timeframe
    Four hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43
    End point values
    		 Cystic Fibrosis Participants Non-cystic Fibrosis Participants
    Number of subjects analysed
    8
    18
    Units: Days
        arithmetic mean (standard deviation)
    19.5 ( 12.39 )
    23.1 ( 13.73 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Day 88
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    Cystic Fibrosis Participants
    Reporting group description
    		 Posaconazole 400 mg oral solution twice daily administered with Calogen® 30 mL oral emulsion (administered before the posaconazole to optimize absorption) for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day and Calogen® 15 mL if the participant was unable to meet the conditions for optimal absorption of posaconazole.

    Reporting group title
    Non-cystic Fibrosis Participants
    Reporting group description
    		 Posaconazole 400 mg oral solution twice daily administered with Calogen® 30 mL oral emulsion (administered before the posaconazole to optimize absorption) for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day and Calogen® 15 mL if the participant was unable to meet the conditions for optimal absorption of posaconazole.

    Serious adverse events
    		 Cystic Fibrosis Participants Non-cystic Fibrosis Participants
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 8 (75.00%)
    10 / 18 (55.56%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    Investigations
    Immunosuppressant drug level decreased
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Supraventricular tachycardia
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral infarction
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 18 (11.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Systemic inflammatory response syndrome
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Transplant rejection
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Liver injury
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic function abnormal
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure acute
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 18 (11.11%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Fungal infection
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 18 (11.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Cystic Fibrosis Participants Non-cystic Fibrosis Participants
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 8 (12.50%)
    2 / 18 (11.11%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Immunosuppressant drug level increased
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Eye disorders
    Vision blurred
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Renal failure acute
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    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? Yes
    Date
    Interruption
    Restart date
    22 Nov 2013
    The trial was terminated on 12-Dec-2013. Reason for early termination: A crude analysis of historic data gave the site concerns that there may have been an increased rate of renal failure requiring renal replacement therapy. Additionally, they found it difficult to titrate the tacrolimus level given the variability of posaconazole - which may have contributed in some cases to the perceived renal issue.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    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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