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    Clinical Trial Results:
    A randomized, open-label, single center, phase I, cross-over study to evaluate the pharmacokinetic comparability of deferasirox new tablet formulation with the reference dispersible formulation in healthy adult subjects

    Summary
    EudraCT number
    		 2016-000248-32
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    27 Sep 2012

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Jul 2018
    First version publication date
    26 Jul 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CICL670F2102
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH 4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, +41 613241111,
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, +41 613241111,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001103-PIP01-10
    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
    27 Sep 2012
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Sep 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the trial was to evaluate the pharmacokinetic (PK) comparability of deferasirox with a reduced dosage strength of the new oral film coated tablet vs. the reference marketed dispersible tablets in healthy subjects under fasted conditions.
    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 subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Jul 2012
    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 States: 44
    Worldwide total number of subjects
    44
    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)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    44
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at a single center in United States.

    Pre-assignment
    Screening details
    		 Of the 44 subjects enrolled, only 34 subjects were randomized and treated. Remaining 10 subjects were not randomized, received only iron-supplementation and discontinued due to following reasons: Administrative problem (7), Subject withdrawn consent (2), Lost to follow-up (1).

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Deferasirox (Film coated then dispersible tablets)
    Arm description
    		 Subjects were initially administered with 3*360 milligrams (mg) film coated tablets of deferasirox for a total dose of 1080 mg, followed by 3*500 mg dispersible tablets of deferasirox for a total of 1500 mg. Subjects received deferasirox with a glass of water (240 milliliter (mL) in the morning after an overnight fast (last meal or snack taken at least 10 hours (hr) earlier) and at least 1 hr before breakfast. After ingestion of dispersible tablets, the glass was rinsed with an additional 40 mL of water and administered to the subject. A washout period of 8 days was maintained between two treatments.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Deferasirox
    Investigational medicinal product code
    ICL670
    Other name
    Pharmaceutical forms
    Dispersible tablet, Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were orally administered with 3*360 mg deferasirox film coated tablet followed by 3*500 mg deferasirox dispersible tablet in morning after an overnight fast (last meal or snack taken at least 10 hrs earlier) and at least 1 hr before breakfast. A washout period of 8 day was maintained between two treatments.

    Arm title
    		 Deferasirox (Dispersible then film coated tablets)
    Arm description
    		 Subjects were initially administered with 3*500 mg dispersible tablets of deferasirox for a total of 1500 mg followed by 3*360 mg film coated tablets of deferasirox for a total dose of 1080 mg. Subjects received deferasirox with a glass of water (240 mL in the morning after an overnight fast (last meal or snack taken at least 10 hr earlier) and at least 1 hr before breakfast. After ingestion of dispersible tablets, the glass was rinsed with an additional 40 mL of water and administered to the subject. A washout period of 8 day was maintained between two treatments.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Deferasirox
    Investigational medicinal product code
    ICL670
    Other name
    Pharmaceutical forms
    Dispersible tablet, Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were orally administered with 3*500 mg deferasirox dispersible tablet followed by 3*360 mg deferasirox film coated tablet in morning after an overnight fast (last meal or snack taken at least 10 hr earlier) and at least 1 hr before breakfast. A washout period of 8 day was maintained between two treatments.

    Number of subjects in period 1 [1]
    		Deferasirox (Film coated then dispersible tablets) Deferasirox (Dispersible then film coated tablets)
    Started
    17
    17
    Completed
    16
    16
    Not completed
    1
    1
         Consent withdrawn by subject
    -
    1
         Administrative Problems
    1
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled as out of 44 subjects, only 34 subjects were randomized and treated in the trial.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Deferasirox (Film coated then dispersible tablets)
    Reporting group description
    		 Subjects were initially administered with 3*360 milligrams (mg) film coated tablets of deferasirox for a total dose of 1080 mg, followed by 3*500 mg dispersible tablets of deferasirox for a total of 1500 mg. Subjects received deferasirox with a glass of water (240 milliliter (mL) in the morning after an overnight fast (last meal or snack taken at least 10 hours (hr) earlier) and at least 1 hr before breakfast. After ingestion of dispersible tablets, the glass was rinsed with an additional 40 mL of water and administered to the subject. A washout period of 8 days was maintained between two treatments.

    Reporting group title
    Deferasirox (Dispersible then film coated tablets)
    Reporting group description
    		 Subjects were initially administered with 3*500 mg dispersible tablets of deferasirox for a total of 1500 mg followed by 3*360 mg film coated tablets of deferasirox for a total dose of 1080 mg. Subjects received deferasirox with a glass of water (240 mL in the morning after an overnight fast (last meal or snack taken at least 10 hr earlier) and at least 1 hr before breakfast. After ingestion of dispersible tablets, the glass was rinsed with an additional 40 mL of water and administered to the subject. A washout period of 8 day was maintained between two treatments.

    Reporting group values
    		 Deferasirox (Film coated then dispersible tablets) Deferasirox (Dispersible then film coated tablets) Total
    Number of subjects
    		 17 17 34
    Age categorical
    Units: Subjects
        Adults (18-55 years)
    		 17 17 34
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 35.53 ± 12.841 36.71 ± 11.351 -
    Gender categorical
    Units: Subjects
        Female
    		 5 5 10
        Male
    		 12 12 24

    End points

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    End points reporting groups
    Reporting group title
    Deferasirox (Film coated then dispersible tablets)
    Reporting group description
    		 Subjects were initially administered with 3*360 milligrams (mg) film coated tablets of deferasirox for a total dose of 1080 mg, followed by 3*500 mg dispersible tablets of deferasirox for a total of 1500 mg. Subjects received deferasirox with a glass of water (240 milliliter (mL) in the morning after an overnight fast (last meal or snack taken at least 10 hours (hr) earlier) and at least 1 hr before breakfast. After ingestion of dispersible tablets, the glass was rinsed with an additional 40 mL of water and administered to the subject. A washout period of 8 days was maintained between two treatments.

    Reporting group title
    Deferasirox (Dispersible then film coated tablets)
    Reporting group description
    		 Subjects were initially administered with 3*500 mg dispersible tablets of deferasirox for a total of 1500 mg followed by 3*360 mg film coated tablets of deferasirox for a total dose of 1080 mg. Subjects received deferasirox with a glass of water (240 mL in the morning after an overnight fast (last meal or snack taken at least 10 hr earlier) and at least 1 hr before breakfast. After ingestion of dispersible tablets, the glass was rinsed with an additional 40 mL of water and administered to the subject. A washout period of 8 day was maintained between two treatments.

    Subject analysis set title
    Deferasirox (Film coated tablet)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All subjects who were administered with a total dose of 3*360 mg (1080 mg) deferasirox as film coated tablets with a glass of water (240 mL in the morning after an overnight fast (last meal or snack taken at least 10 hr earlier) and at least 1 hr before breakfast. The subjects were analysed based on PK analysis set (PAS) defined as all safety subjects (subjects who received at least one dose of investigational product) who completed both treatment periods and provided evaluable PK.

    Subject analysis set title
    Deferasirox (Dispersible tablet)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All subjects who were administered with a total dose of 3*500 mg (1500 mg) deferasirox as dispersible tablets with a glass of water (240 mL in the morning after an overnight fast (last meal or snack taken at least 10 hr earlier) and at least 1 hr before breakfast. After ingestion of dispersible tablets, the glass was rinsed with an additional 40 mL of water and administered to the subject. The analysis was performed on PAS population.

    Subject analysis set title
    Iron Supplement
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects were daily administered with iron supplement (ferrous sulfate) 325 mg oral tablet as supportive treatment for 8 days prior to deferasirox treatment. A washout period of 6 days was maintained between supportive and deferasirox treatment. The subjects were analysed based on safety set defined as all randomized subjects who received at least one dose of investigational product (deferasirox or iron supplement).

    Primary: Area under the concentration-time curve from time zero to the last measurable concentration (AUClast) of deferasirox

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    End point title
    		 Area under the concentration-time curve from time zero to the last measurable concentration (AUClast) of deferasirox
    End point description
    AUClast was defined as the area under the concentration-time curve from time zero to the last measurable concentration sampling time micromole (µmol)*hr /Litre (L). The AUClast was derived based on the non-compartmental methods using Phoenix WinNonlin version 6.2. The analysis was performed in PAS population.
    End point type
    Primary
    End point timeframe
    Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hr post-dose
    End point values
    		 Deferasirox (Film coated tablet) Deferasirox (Dispersible tablet)
    Number of subjects analysed
    32
    32
    Units: µmol*hr/L
        geometric mean (geometric coefficient of variation)
    1273.78 ± 39.22
    1270.79 ± 49.7
    Statistical analysis title
    		 AUClast of deferasirox
    Statistical analysis description
    Geometric mean ratio of AUClast for deferasirox (film-coated tablet and dispersible tablet) was evaluated. The total number of subjects analysed in this endpoint were 32 but as this is a cross-over study the subjects analysed below are featuring as 64 as the number of subjects adds up on selecting the two arms that are being compared [Deferasirox Film coated tablet (N=32) and Deferasirox Dispersible tablet (N=32)].
    Comparison groups
    Deferasirox (Dispersible tablet) v Deferasirox (Film coated tablet)
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Geometric Mean Ratio
    Point estimate
    1
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.932
         upper limit
    		 1.078

    Primary: Area under the plasma concentration-time curve from time zero to infinity (AUCinf) of deferasirox

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    End point title
    		 Area under the plasma concentration-time curve from time zero to infinity (AUCinf) of deferasirox
    End point description
    AUCinf was defined as the area under the plasma concentration-time curve from time zero to infinity (µmol*hr/L). The AUCinf was derived based on the non-compartmental methods using Phoenix WinNonlin version 6.2. The analysis was performed in PAS population.
    End point type
    Primary
    End point timeframe
    Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hr post-dose
    End point values
    		 Deferasirox (Film coated tablet) Deferasirox (Dispersible tablet)
    Number of subjects analysed
    32
    32
    Units: µmol*hr/L
        geometric mean (geometric coefficient of variation)
    1307.04 ± 39.15
    1327.01 ± 50.29
    Statistical analysis title
    		 AUCinf of deferasirox
    Statistical analysis description
    Geometric mean ratio of AUCinf for deferasirox (film-coated tablet and dispersible tablet) was evaluated. The total number of subjects analysed in this endpoint were 32 but as this is a cross-over study the subjects analysed below are featuring as 64 as the number of subjects adds up on selecting the two arms that are being compared [Deferasirox Film coated tablet (N=32) and Deferasirox Dispersible tablet (N=32)].
    Comparison groups
    Deferasirox (Film coated tablet) v Deferasirox (Dispersible tablet)
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Geometric Ratio
    Point estimate
    0.98
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.916
         upper limit
    		 1.059

    Primary: Maximum (peak) observed plasma concentration after a single-dose administration (Cmax) of deferasirox

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    End point title
    		 Maximum (peak) observed plasma concentration after a single-dose administration (Cmax) of deferasirox
    End point description
    Cmax was defined as the maximum (peak) observed plasma concentration after a single-dose administration (µmol/L). The Cmax was derived based on the non-compartmental methods using Phoenix WinNonlin version 6.2. The analysis was performed in PAS population.
    End point type
    Primary
    End point timeframe
    Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hr post-dose
    End point values
    		 Deferasirox (Film coated tablet) Deferasirox (Dispersible tablet)
    Number of subjects analysed
    32
    32
    Units: µmol/L
        geometric mean (geometric coefficient of variation)
    105.83 ± 27.54
    81.54 ± 33.35
    Statistical analysis title
    		 Cmax of deferasirox
    Statistical analysis description
    Geometric mean ratio of Cmax for deferasirox (film-coated tablet and dispersible tablet) was evaluated. The total number of subjects analysed in this endpoint were 32 but as this is a cross-over study the subjects analysed below are featuring as 64 as the number of subjects adds up on selecting the two arms that are being compared [Deferasirox Film coated tablet (N=32) and Deferasirox Dispersible tablet (N=32)].
    Comparison groups
    Deferasirox (Film coated tablet) v Deferasirox (Dispersible tablet)
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Geometric Ratio
    Point estimate
    1.3
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 1.203
         upper limit
    		 1.4

    Secondary: Time to reach maximum (peak) plasma concentration after a single-dose administration (Tmax) of deferasirox

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    End point title
    		 Time to reach maximum (peak) plasma concentration after a single-dose administration (Tmax) of deferasirox
    End point description
    Tmax was defined as the time to reach maximum (peak) plasma concentration after a single-dose administration (hr). The Tmax was derived based on the non-compartmental methods using Phoenix WinNonlin version 6.2. The analysis was performed in PAS population.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hr post-dose
    End point values
    		 Deferasirox (Film coated tablet) Deferasirox (Dispersible tablet)
    Number of subjects analysed
    32
    32
    Units: hr
        median (full range (min-max))
    2 (1.5 to 6.03)
    3 (1 to 8)
    No statistical analyses for this end point

    Secondary: Elimination half-life with the terminal slope (lambda_z) of a semi-logarithmic concentration-time curve (T1/2) of deferasirox

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    End point title
    		 Elimination half-life with the terminal slope (lambda_z) of a semi-logarithmic concentration-time curve (T1/2) of deferasirox
    End point description
    T1/2 was defined as the elimination half-life with the terminal slope (i.e. lambda_z) of a semi-logarithmic concentration-time curve (hr). The T1/2 was derived based on the non-compartmental methods using Phoenix WinNonlin version 6.2. The analysis was performed in PAS population.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hr post-dose
    End point values
    		 Deferasirox (Film coated tablet) Deferasirox (Dispersible tablet)
    Number of subjects analysed
    32
    32
    Units: hr
        geometric mean (geometric coefficient of variation)
    12.48 ± 30.69
    15.64 ± 29.47
    No statistical analyses for this end point

    Secondary: Terminal slope of the elimination phase (Lambda_z) of deferasirox

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    End point title
    		 Terminal slope of the elimination phase (Lambda_z) of deferasirox
    End point description
    Lambda_z was defined as the terminal slope of elimination phase (1/hr). The Lambda_z was derived based on the non-compartmental methods using Phoenix WinNonlin version 6.2. The analysis was performed in PAS population.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hr post-dose
    End point values
    		 Deferasirox (Film coated tablet) Deferasirox (Dispersible tablet)
    Number of subjects analysed
    32
    32
    Units: 1/hr
        geometric mean (geometric coefficient of variation)
    0.06 ± 30.7
    0.04 ± 29.45
    No statistical analyses for this end point

    Secondary: Number of subjects with Adverse events (AEs), Serious adverse events (SAEs), Discontinued due to AEs and who died

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    End point title
    		 Number of subjects with Adverse events (AEs), Serious adverse events (SAEs), Discontinued due to AEs and who died
    End point description
    AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalisation, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards. The analysis was performed on safety set population.
    End point type
    Secondary
    End point timeframe
    From Day 1 up to Day 43
    End point values
    		 Deferasirox (Film coated tablet) Deferasirox (Dispersible tablet) Iron Supplement
    Number of subjects analysed
    32
    32
    34
    Units: Subjects
        AEs
    11
    6
    3
        SAEs
    0
    0
    0
        Deaths
    0
    0
    0
        AEs leading to discontinuation
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs were collected from First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All AEs reported in this record were from date of First Subject First Treatment until LSLV.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.0
    Reporting groups
    Reporting group title
    Deferasirox (Film coated tablet)
    Reporting group description
    		 All subjects who received a total dose of 3*360 mg (1080 mg) deferasirox as film coated tablets with a glass of water (240 mL in the morning after an overnight fast (last meal or snack taken at least 10 hr earlier) and at least 1 hr before breakfast during the study.

    Reporting group title
    Deferasirox (Dispersible tablet)
    Reporting group description
    		 All subjects who recieved a total dose of 3*500 mg (1500 mg) deferasirox as dispersible tablets with a glass of water (240 mL in the morning after an overnight fast (last meal or snack taken at least 10 hr earlier) and at least 1 hr before breakfast during the study.

    Reporting group title
    Iron supplement
    Reporting group description
    		 All subjects who recieved iron supplement (ferrous sulfate) 325 mg oral tablet as supportive treatment for 8 days prior to deferasirox treatment during the study.

    Reporting group title
    All Subjects
    Reporting group description
    		 All Subjects who received at least one dose of study treatment.

    Serious adverse events
    		 Deferasirox (Film coated tablet) Deferasirox (Dispersible tablet) Iron supplement All Subjects
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 34 (0.00%)
    0 / 34 (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: 2%
    Non-serious adverse events
    		 Deferasirox (Film coated tablet) Deferasirox (Dispersible tablet) Iron supplement All Subjects
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 32 (34.38%)
    6 / 32 (18.75%)
    3 / 34 (8.82%)
    15 / 34 (44.12%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 34 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    1
    0
    0
    1
    Headache
         subjects affected / exposed
    1 / 32 (3.13%)
    2 / 32 (6.25%)
    0 / 34 (0.00%)
    3 / 34 (8.82%)
         occurrences all number
    1
    2
    0
    3
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 34 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    1
    0
    0
    1
    Pain
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 34 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    0
    1
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 34 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    1
    0
    0
    1
    Abnormal faeces
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 34 (2.94%)
    1 / 34 (2.94%)
         occurrences all number
    0
    0
    1
    1
    Diarrhoea
         subjects affected / exposed
    7 / 32 (21.88%)
    3 / 32 (9.38%)
    0 / 34 (0.00%)
    8 / 34 (23.53%)
         occurrences all number
    7
    3
    0
    10
    Dyspepsia
         subjects affected / exposed
    1 / 32 (3.13%)
    1 / 32 (3.13%)
    0 / 34 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    1
    1
    0
    2
    Faeces discoloured
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 34 (2.94%)
    1 / 34 (2.94%)
         occurrences all number
    0
    0
    1
    1
    Infrequent bowel movements
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 34 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    1
    0
    0
    1
    Reproductive system and breast disorders
    Menstruation irregular
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 34 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    1
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 34 (2.94%)
    1 / 34 (2.94%)
         occurrences all number
    0
    0
    1
    1
    Papule
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 34 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    0
    1
    Pruritus
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 34 (2.94%)
    1 / 34 (2.94%)
         occurrences all number
    0
    0
    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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    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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