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    Clinical Trial Results:
    An Interventional PK, PD, Phase 1, Open-Label Study to Investigate PK and PD of Multiple-Dose Ritlecitinib in Children 6 to Less Than 12 Years of Age With Severe Alopecia Areata

    Summary
    EudraCT number
    2023-000824-12
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    11 Aug 2023

    Results information
    Results version number
    v1(current)
    This version publication date
    28 Jan 2024
    First version publication date
    28 Jan 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    B7981031
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT05650333
    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 ClinicalTrials.gov Call Centre, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Centre, Pfizer Inc., 001 8007181021, 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-002451-PIP01-18
    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
    18 Dec 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Aug 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the trial was to characterise the pharmacokinetics (PK) of Ritlectinib in subjects with alopecia areata (AA) 6 to less than (<) 12 years of age.
    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 Council for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trials subjects were followed.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    02 Mar 2023
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 15
    Worldwide total number of subjects
    15
    EEA total number of subjects
    0
    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)
    15
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    A total of 15 subjects were enrolled at 6 sites in the United States. Study started from 02 March 2023 and completed on 11 August 2023.

    Period 1
    Period 1 title
    Treatment Period
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Ritlecitinib 20 mg
    Arm description
    Subjects received Ritlecitinib 20 milligram (mg) orally once daily (QD), for 7 consecutive days.
    Arm type
    Experimental

    Investigational medicinal product name
    Ritlecitinib
    Investigational medicinal product code
    PF-06651600
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Ritlecitinib 20 mg, orally QD, for 7 consecutive days.

    Number of subjects in period 1
    Ritlecitinib 20 mg
    Started
    15
    Completed
    14
    Not completed
    1
         Adverse event, non-fatal
    1
    Period 2
    Period 2 title
    Follow-up Period
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Ritlecitinib 20 mg
    Arm description
    Subjects received Ritlecitinib 20 mg, orally QD, for 7 consecutive days.
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    Ritlecitinib 20 mg
    Started
    14
    Completed
    15
    Joined
    1
         For follow-up
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ritlecitinib 20 mg
    Reporting group description
    Subjects received Ritlecitinib 20 milligram (mg) orally once daily (QD), for 7 consecutive days.

    Reporting group values
    Ritlecitinib 20 mg Total
    Number of subjects
    15 15
    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)
    15 15
        Adolescents (12-17 years)
    0 0
        Adults (18-64 years)
    0 0
        From 65-84 years
    0 0
        85 years and over
    0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    8.5 ± 1.60 -
    Gender Categorical
    Units: Subjects
        Female
    12 12
        Male
    3 3
    Race
    Units: Subjects
        White
    13 13
        Black or African American
    2 2
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    8 8
        Not Hispanic or Latino
    7 7

    End points

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    End points reporting groups
    Reporting group title
    Ritlecitinib 20 mg
    Reporting group description
    Subjects received Ritlecitinib 20 milligram (mg) orally once daily (QD), for 7 consecutive days.
    Reporting group title
    Ritlecitinib 20 mg
    Reporting group description
    Subjects received Ritlecitinib 20 mg, orally QD, for 7 consecutive days.

    Primary: Area Under the Plasma Concentration-Time Profile Over the Dosing Interval of 24 Hours, at Steady State (AUC24) of Ritlecitinib on Day 7

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    End point title
    Area Under the Plasma Concentration-Time Profile Over the Dosing Interval of 24 Hours, at Steady State (AUC24) of Ritlecitinib on Day 7 [1]
    End point description
    Linear-log trapezoidal method was used for evaluation. The pharmacokinetic (PK) parameter analysis population included all subjects treated who had at least 1 of the PK parameters of primary interest. Here, “Number of Subjects Analyzed” signifies number of subjects evaluable for this endpoint. Two subjects were not included in analysis because they did not have evaluable PK data.
    End point type
    Primary
    End point timeframe
    0 (pre-dose), 0.5, 1, 3, 8 and 24 hours post-dose on Day 7 [Pre-dose concentration was used as an estimate for the concentration of 24 hours 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: Statistical analysis was not planned for this endpoint.
    End point values
    Ritlecitinib 20 mg
    Number of subjects analysed
    13
    Units: Nanogram*hours per millilitre (ng*hr/mL)
        geometric mean (geometric coefficient of variation)
    437.5 ± 30
    No statistical analyses for this end point

    Secondary: Maximum Observed Plasma Concentration (Cmax) of Ritlecitinib

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    End point title
    Maximum Observed Plasma Concentration (Cmax) of Ritlecitinib
    End point description
    The PK parameter analysis population included all subjects treated who had at least 1 of the PK parameters of primary interest. Here, “Number of Subjects Analyzed” signifies number of subjects evaluable for this endpoint. Two subjects were not included in analysis because they did not have evaluable PK data.
    End point type
    Secondary
    End point timeframe
    0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7
    End point values
    Ritlecitinib 20 mg
    Number of subjects analysed
    13
    Units: Nanogram per millilitre (ng/mL)
        geometric mean (geometric coefficient of variation)
    208.7 ± 38
    No statistical analyses for this end point

    Secondary: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Ritlecitinib

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    End point title
    Time to Reach Maximum Observed Plasma Concentration (Tmax) of Ritlecitinib
    End point description
    The PK parameter analysis population included all subjects treated who had at least 1 of the PK parameters of primary interest. Here, “Number of Subjects Analyzed” signifies number of subjects evaluable for this endpoint. Two subjects were not included in analysis because they did not have evaluable PK data.
    End point type
    Secondary
    End point timeframe
    0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7
    End point values
    Ritlecitinib 20 mg
    Number of subjects analysed
    13
    Units: Hours
        median (full range (min-max))
    0.500 (0.450 to 1.00)
    No statistical analyses for this end point

    Secondary: Apparent Oral Clearance (CL/F) of Ritlecitinib

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    End point title
    Apparent Oral Clearance (CL/F) of Ritlecitinib
    End point description
    Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological process. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. The PK parameter analysis population included all subjects treated who had at least 1 of the PK parameters of primary interest. Here, “Number of Subjects Analyzed” signifies number of subjects evaluable for this endpoint. Two subjects were not included in analysis because they did not have evaluable PK data.
    End point type
    Secondary
    End point timeframe
    0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7
    End point values
    Ritlecitinib 20 mg
    Number of subjects analysed
    13
    Units: Litre per hour (L/hr)
        geometric mean (geometric coefficient of variation)
    45.70 ± 30
    No statistical analyses for this end point

    Secondary: Apparent Volume of Distribution (Vz/F) of Ritlecitinib

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    End point title
    Apparent Volume of Distribution (Vz/F) of Ritlecitinib
    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 plasma concentration of a drug. Vz/F is influenced by the fraction absorbed. The PK parameter analysis population included all subjects treated who had at least 1 of the PK parameters of primary interest. Here, “Number of Subjects Analyzed” signifies number of subjects evaluable for this endpoint. Two subjects were not included in analysis because they did not have evaluable PK data.
    End point type
    Secondary
    End point timeframe
    0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7
    End point values
    Ritlecitinib 20 mg
    Number of subjects analysed
    13
    Units: Litre
        geometric mean (geometric coefficient of variation)
    74.92 ± 23
    No statistical analyses for this end point

    Secondary: Terminal Elimination Half-Life (t1/2) of Ritlecitinib

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    End point title
    Terminal Elimination Half-Life (t1/2) of Ritlecitinib
    End point description
    The PK parameter analysis population included all subjects treated who had at least 1 of the PK parameters of primary interest. Here, “Number of Subjects Analyzed” signifies number of subjects evaluable for this endpoint. Two subjects were not included in analysis because they did not have evaluable PK data.
    End point type
    Secondary
    End point timeframe
    0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7
    End point values
    Ritlecitinib 20 mg
    Number of subjects analysed
    13
    Units: Hours
        arithmetic mean (standard deviation)
    1.191 ± 0.10776
    No statistical analyses for this end point

    Secondary: Change From Baseline in Interferon Gamma Induced Protein 10 (IP-10) on Day 7

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    End point title
    Change From Baseline in Interferon Gamma Induced Protein 10 (IP-10) on Day 7
    End point description
    The pharmacodynamic (PD) parameter analysis population included all subjects treated who had at least 1 of the PD parameters of primary interest. Here, “n” signifies number of subjects evaluable for specified rows.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 7
    End point values
    Ritlecitinib 20 mg
    Number of subjects analysed
    15
    Units: Picogram per millilitre (pg/mL)
    median (full range (min-max))
        Baseline (n =15)
    121.0 (74.7 to 888.0)
        Change at Day 7 (n =12)
    -9.9 (-555.0 to 104.0)
    No statistical analyses for this end point

    Secondary: Change From Baseline in T Lymphocytes on Day 7

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    End point title
    Change From Baseline in T Lymphocytes on Day 7
    End point description
    The PD parameter analysis population included all subjects treated who had at least 1 of the PD parameters of primary interest. T lymphocytes included CD3 cells, CD4 T helper lymphocytes and CD8 T cytotoxic lymphocytes. Here, “n” signifies number of subjects evaluable for specified rows.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 7
    End point values
    Ritlecitinib 20 mg
    Number of subjects analysed
    15
    Units: 10^9 Cells per litre
    median (full range (min-max))
        CD3 cells: Baseline (n=15)
    1.8 (0.8 to 3.4)
        CD3 cells: Change at Day 7(n=12)
    -0.0 (-1.3 to 2.0)
        CD4 T helper lymphocytes: Baseline (n=15)
    1.0 (0.6 to 1.6)
        CD4 T helper lymphocytes: Change at Day 7(n=12)
    -0.1 (-0.6 to 1.1)
        CD8 T cytotoxic lymphocytes: Baseline (n=15)
    0.6 (0.2 to 1.5)
        CD8 T cytotoxic lymphocytes: Change at Day 7(n=12)
    0.0 (-0.6 to 0.8)
    No statistical analyses for this end point

    Secondary: Change From Baseline in B Lymphocytes on Day 7

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    End point title
    Change From Baseline in B Lymphocytes on Day 7
    End point description
    The PD parameter analysis population included all subjects treated who had at least 1 of the PD parameters of primary interest. B lymphocytes included CD19 cells. Here, “n” signifies number of subjects evaluable for specified rows.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 7
    End point values
    Ritlecitinib 20 mg
    Number of subjects analysed
    15
    Units: 10^6 Cells per litre
    median (full range (min-max))
        Baseline (n =15)
    439.0 (191.0 to 881.0)
        Change at Day 7 (n =12)
    -19.0 (-116.0 to 766.0)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Natural Killer (NK) Cells on Day 7

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    End point title
    Change From Baseline in Natural Killer (NK) Cells on Day 7
    End point description
    The PD parameter analysis population included all subjects treated who had at least 1 of the PD parameters of primary interest. NK cells included CD3 (-), CD16 (+), CD56 (+) cells. Here, “n” signifies number of subjects evaluable for specified rows.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 7
    End point values
    Ritlecitinib 20 mg
    Number of subjects analysed
    15
    Units: 10^6 Cells per litre
    median (full range (min-max))
        Baseline (n =15)
    254.0 (85.0 to 729.0)
        Change at Day 7 (n =12)
    -25.5 (-318.0 to 627.0)
    No statistical analyses for this end point

    Secondary: Number of Subjects With Treatment Emergent Adverse Events (TEAEs)

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    End point title
    Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
    End point description
    An AE is any untoward medical occurrence in a subject or clinical study subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent were events between first dose to 35 days after last dose, that were absent before treatment or that worsened relative to pretreatment state. Safety analysis set included all subjects assigned to study intervention and who received at least 1 dose of study intervention. Subjects were analysed according to the product they actually received.
    End point type
    Secondary
    End point timeframe
    Day 1 of dosing up to 35 days after the last dose (Day 42)
    End point values
    Ritlecitinib 20 mg
    Number of subjects analysed
    15
    Units: Subjects
    3
    No statistical analyses for this end point

    Secondary: Number of Subjects With Treatment Related AEs

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    End point title
    Number of Subjects With Treatment Related AEs
    End point description
    Treatment-related AE was any untoward medical occurrence attributed to study drug in a subject who received study drug. Safety analysis set included all subjects assigned to study intervention and who received at least 1 dose of study intervention. Subjects were analysed according to the product they actually received.
    End point type
    Secondary
    End point timeframe
    Day 1 of dosing up to 35 days after the last dose (Day 42)
    End point values
    Ritlecitinib 20 mg
    Number of subjects analysed
    15
    Units: Subjects
    1
    No statistical analyses for this end point

    Secondary: Number of Subjects With Serious AEs (SAEs)

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    End point title
    Number of Subjects With Serious AEs (SAEs)
    End point description
    SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Safety analysis set included all subjects assigned to study intervention and who received at least 1 dose of study intervention. Subjects were analysed according to the product they actually received.
    End point type
    Secondary
    End point timeframe
    Day 1 of dosing up to 35 days after the last dose (Day 42)
    End point values
    Ritlecitinib 20 mg
    Number of subjects analysed
    15
    Units: Subjects
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With AEs Leading to Treatment Discontinuation

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    End point title
    Number of Subjects With AEs Leading to Treatment Discontinuation
    End point description
    Safety analysis set included all subjects assigned to study intervention and who received at least 1 dose of study intervention. Subjects were analysed according to the product they actually received.
    End point type
    Secondary
    End point timeframe
    Day 1 up to Day 7
    End point values
    Ritlecitinib 20 mg
    Number of subjects analysed
    15
    Units: Subjects
    1
    No statistical analyses for this end point

    Secondary: Number of Subjects With Clinically Significant Abnormalities in Vital Signs

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    End point title
    Number of Subjects With Clinically Significant Abnormalities in Vital Signs
    End point description
    Vital Signs evaluation included blood pressure and heart rate measurements. Clinical significance was judged by investigator. Safety analysis set included all subjects assigned to study intervention and who received at least 1 dose of study intervention. Subjects were analysed according to the product they actually received.
    End point type
    Secondary
    End point timeframe
    Day 1 up to Day 7
    End point values
    Ritlecitinib 20 mg
    Number of subjects analysed
    15
    Units: Subjects
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Clinically Significant Abnormalities in Clinical Laboratory Values

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    End point title
    Number of Subjects With Clinically Significant Abnormalities in Clinical Laboratory Values
    End point description
    Clinical laboratory parameters included haematology: haemoglobin, haematocrit, red blood cells count, platelet count, white blood cells count, total absolute: neutrophils, eosinophils, monocytes, basophils, lymphocytes; chemistry: urea and creatinine estimated creatinine clearance, glucose (fasting), sodium, potassium, chloride, aspartate aminotransferase (AT), alanine AT, total bilirubin, alkaline phosphatase, albumin, total protein; urinalysis: local dipstick: pH, qualitative: glucose, protein, albuminuria, blood, ketones, nitrites, leukocyte esterase and others. Clinical significance was judged by investigator. Safety analysis set was evaluated.
    End point type
    Secondary
    End point timeframe
    Day 1 up to Day 7
    End point values
    Ritlecitinib 20 mg
    Number of subjects analysed
    15
    Units: Subjects
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects as per Score for Paediatric Taste Assessment Questionnaire

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    End point title
    Number of Subjects as per Score for Paediatric Taste Assessment Questionnaire
    End point description
    The paediatric taste questionnaire included 3 questions regarding: 1) Overall Taste, 2) Overall Mouthfeel and 3) Overall Volume of Medicine. Each question ranged from 1 (most favourable) to 5 (least favourable). Safety analysis set included all subjects assigned to study intervention and who received at least 1 dose of study intervention. Subjects were analysed according to the product they actually received. Here, “Number of Subjects Analyzed” signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Day 1 and 7
    End point values
    Ritlecitinib 20 mg
    Number of subjects analysed
    14
    Units: Subjects
        Day 1: Taste, Score 1
    1
        Day 1: Taste, Score 2
    0
        Day 1: Taste, Score 3
    3
        Day 1: Taste, Score 4
    3
        Day 1: Taste, Score 5
    7
        Day 1: Mouthfeel, Score 1
    0
        Day 1: Mouthfeel, Score 2
    5
        Day 1: Mouthfeel, Score 3
    3
        Day 1: Mouthfeel, Score 4
    4
        Day 1: Mouthfeel, Score 5
    2
        Day 1: Volume, Score 1
    2
        Day 1: Volume, Score 2
    5
        Day 1: Volume, Score 3
    2
        Day 1: Volume, Score 4
    2
        Day 1: Volume, Score 5
    3
        Day 7: Taste, Score 1
    0
        Day 7: Taste, Score 2
    1
        Day 7: Taste, Score 3
    4
        Day 7: Taste, Score 4
    2
        Day 7: Taste, Score 5
    7
        Day 7: Mouthfeel, Score 1
    0
        Day 7: Mouthfeel, Score 2
    5
        Day 7: Mouthfeel, Score 3
    3
        Day 7: Mouthfeel, Score 4
    5
        Day 7: Mouthfeel, Score 5
    1
        Day 7: Volume, Score 1
    1
        Day 7: Volume, Score 2
    6
        Day 7: Volume, Score 3
    2
        Day 7: Volume, Score 4
    1
        Day 7: Volume, Score 5
    4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 up to 35 days after last dose (Day 42)
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    Ritlecitinib 20 mg QD
    Reporting group description
    Subjects received Ritlecitinib 20 mg, orally QD, for 7 consecutive days.

    Serious adverse events
    Ritlecitinib 20 mg QD
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 15 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Ritlecitinib 20 mg QD
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 15 (20.00%)
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    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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    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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