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    Clinical Trial Results:
    A Phase 2, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Different Doses of MEDI0382 in Overweight and Obese Subjects with Type 2 Diabetes Mellitus

    Summary
    EudraCT number
    2017-002025-38
    Trial protocol
    DE  
    Global end of trial date
    23 Jan 2018

    Results information
    Results version number
    v2(current)
    This version publication date
    25 May 2019
    First version publication date
    14 Feb 2019
    Other versions
    v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    D5670C00011
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03244800
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    MedImmune Limited
    Sponsor organisation address
    Milstein Building, Granta Park,, Cambridge, United Kingdom, CB21 6GH
    Public contact
    Victoria Parker, MedImmune Limited, +44 747 1357152, information.center@astrazeneca.com
    Scientific contact
    Victoria Parker, MedImmune Limited, +44 747 1357152, information.center@astrazeneca.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
    23 Jan 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Jan 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the effects of MEDI0382 titrated up to a dose level of 300 µg on glucose control and body weight versus placebo after 49 days of treatment (Cohort 1 only).
    Protection of trial subjects
    The conduct of this study met all the local legal and regulatory requirements. The study was conducted in accordance with ethical principles that have their origin in the Declaration of Helsinki and was consistent with the International Council for Harmonisation (ICH) Guidelines on Good Clinical Practice (GCP). Participating participants signed the informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    04 Sep 2017
    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
    Germany: 65
    Worldwide total number of subjects
    65
    EEA total number of subjects
    65
    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)
    45
    From 65 to 84 years
    20
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study was conducted across 5 sites in Germany between 04Sep2017 and 23Jan2018.

    Pre-assignment
    Screening details
    A total of 120 participants consented to participate in the study. Of which 55 were screen failures; 65 participants were randomised (46 to MEDI0382 and 19 to placebo).

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Carer
    Blinding implementation details
    This was a double-blind study (MEDI0382 and placebo are identically labeled and indistinguishable in appearance). Neither the participant nor any of the investigator or sponsor staff who are involved in the treatment or clinical evaluation of the participants were aware of the treatment received.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo Cohort 1
    Arm description
    Participants received placebo matching with MEDI0382 subcutaneously (SC) once daily for 49 days.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo Cohort 1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Sterile concentrate, Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received placebo matching with MEDI0382 subcutaneously (SC) once daily for 49 days.

    Arm title
    MEDI0382 Cohort 1
    Arm description
    Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.
    Arm type
    Experimental

    Investigational medicinal product name
    MEDI0382 Cohort 1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Sterile concentrate
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.

    Arm title
    Placebo Cohort 2
    Arm description
    Participants received placebo matching with MEDI0382 SC once daily for 49 days.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo Cohort 2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection, Sterile concentrate
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received placebo matching with MEDI0382 SC once daily for 49 days.

    Arm title
    MEDI0382 Cohort 2
    Arm description
    Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.
    Arm type
    Experimental

    Investigational medicinal product name
    MEDI0382 Cohort 2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Sterile concentrate
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.

    Number of subjects in period 1
    Placebo Cohort 1 MEDI0382 Cohort 1 Placebo Cohort 2 MEDI0382 Cohort 2
    Started
    13
    26
    6
    20
    Completed
    13
    25
    6
    18
    Not completed
    0
    1
    0
    2
         Adverse event, non-fatal
             -
             1
             -
             1
         Withdrew treatment
             -
             -
             -
             1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo Cohort 1
    Reporting group description
    Participants received placebo matching with MEDI0382 subcutaneously (SC) once daily for 49 days.

    Reporting group title
    MEDI0382 Cohort 1
    Reporting group description
    Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.

    Reporting group title
    Placebo Cohort 2
    Reporting group description
    Participants received placebo matching with MEDI0382 SC once daily for 49 days.

    Reporting group title
    MEDI0382 Cohort 2
    Reporting group description
    Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.

    Reporting group values
    Placebo Cohort 1 MEDI0382 Cohort 1 Placebo Cohort 2 MEDI0382 Cohort 2 Total
    Number of subjects
    13 26 6 20 65
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    11 18 4 12 45
        From 65-84 years
    2 8 2 8 20
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    60.2 ± 5.6 58.7 ± 8.5 60.3 ± 9.5 61.9 ± 6.0 -
    Sex: Female, Male
    Units: Subjects
        Female
    4 7 1 10 22
        Male
    9 19 5 10 43
    Race/Ethnicity, Customized
    Units: Subjects
        Hispanic or Latino
    0 0 0 0 0
        Not Hispanic or Latino
    13 26 6 20 65
    Race/Ethnicity, Customized
    Units: Subjects
        American Indian or Alaskan Native Asian
    0 0 0 0 0
        Black or African American
    0 0 0 0 0
        Native Hawaiian or Other Pacific Islander
    0 1 0 0 1
        White
    13 25 6 20 64
        Other
    0 0 0 0 0
    Subject analysis sets

    Subject analysis set title
    Placebo
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants who received placebo matching with MEDI0382 subcutaneously (SC) once daily for 49 days.

    Subject analysis set title
    MEDI0382
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants who received subcutaneous injection of MEDI0382 once daily for 49 days.

    Subject analysis sets values
    Placebo MEDI0382
    Number of subjects
    19
    46
    Age categorical
    Units: Subjects
        Adults (18-64 years)
        From 65-84 years
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    60.2 ± 6.8
    60.1 ± 7.6
    Sex: Female, Male
    Units: Subjects
        Female
        Male
    Race/Ethnicity, Customized
    Units: Subjects
        Hispanic or Latino
        Not Hispanic or Latino
    Race/Ethnicity, Customized
    Units: Subjects
        American Indian or Alaskan Native Asian
        Black or African American
        Native Hawaiian or Other Pacific Islander
        White
        Other

    End points

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    End points reporting groups
    Reporting group title
    Placebo Cohort 1
    Reporting group description
    Participants received placebo matching with MEDI0382 subcutaneously (SC) once daily for 49 days.

    Reporting group title
    MEDI0382 Cohort 1
    Reporting group description
    Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.

    Reporting group title
    Placebo Cohort 2
    Reporting group description
    Participants received placebo matching with MEDI0382 SC once daily for 49 days.

    Reporting group title
    MEDI0382 Cohort 2
    Reporting group description
    Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.

    Subject analysis set title
    Placebo
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants who received placebo matching with MEDI0382 subcutaneously (SC) once daily for 49 days.

    Subject analysis set title
    MEDI0382
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants who received subcutaneous injection of MEDI0382 once daily for 49 days.

    Primary: Cohort 1: Percent Change From Baseline in Plasma Glucose Area Under the Concentration-time Curve From Time 0 to 4 hours (AUC0-4h) by Mixed-meal Tolerance Test (MMTT) to Day 49

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    End point title
    Cohort 1: Percent Change From Baseline in Plasma Glucose Area Under the Concentration-time Curve From Time 0 to 4 hours (AUC0-4h) by Mixed-meal Tolerance Test (MMTT) to Day 49 [1]
    End point description
    The MMTT test involved the consumption of a standardised liquid meal within 5 minutes and timed serial blood samples obtained for the measurement of glucose and parameters related to glucose metabolism through 240 minutes after consumption of the standardised meal (with no additional food intake during this time). The percent change in the MMTT plasma glucose AUC 0-4h from the baseline (Day -1) to Day 49 is reported. Pharmacodynamic (PD) population included all participants who received at least one dose of study drug and had at least one post-baseline MMTT PD sample or PD evaluation.
    End point type
    Primary
    End point timeframe
    Zero minutes before and 15, 30, 45, 60, 90, 120, 180, and 240 minutes after consumption of the standardised liquid meal
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those baseline period arms for which analysis was planned were reported in the end point.
    End point values
    Placebo Cohort 1 MEDI0382 Cohort 1
    Number of subjects analysed
    13
    26
    Units: Percent change
        least squares mean (confidence interval 95%)
    6.32 (-0.74 to 13.38)
    -21.52 (-26.51 to -16.54)
    Statistical analysis title
    Cohort 1: Statistical analysis
    Comparison groups
    Placebo Cohort 1 v MEDI0382 Cohort 1
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    ANCOVA
    Confidence interval

    Primary: Cohort 1: Percent Change From Baseline in Body Weight to Day 50

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    End point title
    Cohort 1: Percent Change From Baseline in Body Weight to Day 50 [2]
    End point description
    The percent change in body weight from baseline to Day 50 is reported. Intent-to-treat (ITT) population included all participants who received any study drug and were analyzed according to their randomized treatment group.
    End point type
    Primary
    End point timeframe
    Day 1 through Day 50
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those baseline period arms for which analysis was planned were reported in the end point.
    End point values
    Placebo Cohort 1 MEDI0382 Cohort 1
    Number of subjects analysed
    13
    26
    Units: Percent change
        least squares mean (confidence interval 95%)
    -0.21 (-1.88 to 1.46)
    -3.59 (-4.77 to -2.41)
    Statistical analysis title
    Cohort 1: Statistical analysis
    Comparison groups
    Placebo Cohort 1 v MEDI0382 Cohort 1
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.002
    Method
    ANCOVA
    Confidence interval

    Secondary: Cohort 1: Change From Baseline in Glycated Haemoglobin (HbA1c) to Day 49

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    End point title
    Cohort 1: Change From Baseline in Glycated Haemoglobin (HbA1c) to Day 49 [3]
    End point description
    The change from baseline in Glycated haemoglobin (HbA1c) to Day 49 is reported. ITT population included all participants who received any study drug and were analyzed according to their randomized treatment group.
    End point type
    Secondary
    End point timeframe
    Baseline (Day -1) through Day 49
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those baseline period arms for which analysis was planned were reported in the end point.
    End point values
    Placebo Cohort 1 MEDI0382 Cohort 1
    Number of subjects analysed
    13
    26
    Units: Percentage change
        least squares mean (confidence interval 90%)
    -0.07 (-0.27 to 0.14)
    -0.67 (-0.82 to -0.53)
    Statistical analysis title
    Cohort 1: Statistical analysis
    Comparison groups
    Placebo Cohort 1 v MEDI0382 Cohort 1
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    ANCOVA
    Confidence interval

    Secondary: Cohort 1: Change From Baseline in Fasting Plasma Glucose to Day 49

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    End point title
    Cohort 1: Change From Baseline in Fasting Plasma Glucose to Day 49 [4]
    End point description
    The changes in the fasting plasma glucose level during the study period from baseline to Day 49 is reported. ITT population included all participants who received any study drug and were analyzed according to their randomized treatment group.
    End point type
    Secondary
    End point timeframe
    Baseline (Day -1) through Day 49
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those baseline period arms for which analysis was planned were reported in the end point.
    End point values
    Placebo Cohort 1 MEDI0382 Cohort 1
    Number of subjects analysed
    13
    26
    Units: mg/dL
        least squares mean (confidence interval 90%)
    -2.31 (-12.74 to 8.13)
    -35.37 (-42.75 to -27.99)
    Statistical analysis title
    Cohort 1: Statistical analysis
    Comparison groups
    Placebo Cohort 1 v MEDI0382 Cohort 1
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    ANCOVA
    Confidence interval

    Secondary: Cohort 1: Change From Baseline in Body Weight to Day 50

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    End point title
    Cohort 1: Change From Baseline in Body Weight to Day 50 [5]
    End point description
    The changes in the body weight during the study period from baseline to Day 50 is reported. ITT population included all participants who received any study drug and were analyzed according to their randomized treatment group.
    End point type
    Secondary
    End point timeframe
    Day 1 through Day 50
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those baseline period arms for which analysis was planned were reported in the end point.
    End point values
    Placebo Cohort 1 MEDI0382 Cohort 1
    Number of subjects analysed
    13
    26
    Units: Kilogram
        least squares mean (confidence interval 90%)
    -0.08 (-1.45 to 1.28)
    -3.41 (-4.37 to -2.44)
    Statistical analysis title
    Cohort 1: Statistical analysis
    Comparison groups
    Placebo Cohort 1 v MEDI0382 Cohort 1
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.002
    Method
    ANCOVA
    Confidence interval

    Secondary: Cohort 1: Percentage of Participants Achieving Greater Than or Equal to 5% Body Weight Loss from Baseline to Day 50

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    End point title
    Cohort 1: Percentage of Participants Achieving Greater Than or Equal to 5% Body Weight Loss from Baseline to Day 50 [6]
    End point description
    Participants achieving greater than or equal to 5% body weight loss from baseline to Day 50 is reported. ITT population included all participants who received any study drug and were analyzed according to their randomized treatment group.
    End point type
    Secondary
    End point timeframe
    Day 1 through Day 50
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those baseline period arms for which analysis was planned were reported in the end point.
    End point values
    Placebo Cohort 1 MEDI0382 Cohort 1
    Number of subjects analysed
    13
    26
    Units: Percentage of Participants
        number (not applicable)
    7.7
    42.3
    Statistical analysis title
    Cohort 1: Statistical analysis
    Comparison groups
    Placebo Cohort 1 v MEDI0382 Cohort 1
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.04
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    10.76
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    1.61
         upper limit
    72.03

    Secondary: Percent Change From Baseline in MMTT Plasma Glucose AUC 0-4h to Day 7

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    End point title
    Percent Change From Baseline in MMTT Plasma Glucose AUC 0-4h to Day 7
    End point description
    The MMTT test involved the consumption of a standardised liquid meal within 5 minutes and timed serial blood samples obtained for the measurement of glucose and parameters related to glucose metabolism through 240 minutes after consumption of the standardised meal (with no additional food intake during this time). The percent change in the MMTT plasma glucose AUC 0-4h from the baseline (Day -1) evaluation to Day 7 is reported. Pharmacodynamic (PD) population included all participants who received at least one dose of study drug and had at least one post-baseline MMTT PD sample or PD evaluation. The “Number of Subjects Analyzed” denotes the number of participants evaluated for this end point.
    End point type
    Secondary
    End point timeframe
    Zero minutes before and 15, 30, 45, 60, 90, 120, 180, and 240 minutes after consumption of the standardised liquid meal
    End point values
    Placebo MEDI0382
    Number of subjects analysed
    19
    45
    Units: Percent change
        arithmetic mean (standard deviation)
    -0.82 ± 15.72
    -29.12 ± 9.01
    Statistical analysis title
    Statistical analysis
    Comparison groups
    Placebo v MEDI0382
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    ANCOVA
    Confidence interval

    Secondary: Cohort 1 and Cohort 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

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    End point title
    Cohort 1 and Cohort 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
    End point description
    An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is 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. Treatment-emergent are the events between first doses of study drug through 7 to 14 days after the last dose of study drug (approximately 64 days). As-treated population included all participants who received any study drug and were analyzed according to the treatment they received.
    End point type
    Secondary
    End point timeframe
    From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
    End point values
    Placebo Cohort 1 MEDI0382 Cohort 1 Placebo Cohort 2 MEDI0382 Cohort 2
    Number of subjects analysed
    13
    26
    6
    20
    Units: Participants
        TEAEs
    6
    22
    3
    15
        TESAEs
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Cohort 1 and Cohort 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs

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    End point title
    Cohort 1 and Cohort 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs
    End point description
    Treatment-emergent adverse events observed in participants with clinically significant vital signs abnormalities are reported. Vital sign parameters included blood pressure, heart rate, body temperature, and respiration rate. As-treated population included all participants who received any study drug and were analyzed according to the treatment they received.
    End point type
    Secondary
    End point timeframe
    From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
    End point values
    Placebo Cohort 1 MEDI0382 Cohort 1 Placebo Cohort 2 MEDI0382 Cohort 2
    Number of subjects analysed
    13
    26
    6
    20
    Units: Participants
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Cohort 1 and Cohort 2: Number of Participants With Abnormal Electrocardiogram Reported as TEAEs

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    End point title
    Cohort 1 and Cohort 2: Number of Participants With Abnormal Electrocardiogram Reported as TEAEs
    End point description
    Treatment-emergent adverse events observed in participants with clinically significant ECG abnormalities are reported. As-treated population included all participants who received any study drug and were analyzed according to the treatment they received.
    End point type
    Secondary
    End point timeframe
    From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
    End point values
    Placebo Cohort 1 MEDI0382 Cohort 1 Placebo Cohort 2 MEDI0382 Cohort 2
    Number of subjects analysed
    13
    26
    6
    20
    Units: Participants
    0
    0
    0
    1
    No statistical analyses for this end point

    Secondary: Cohort 1 and Cohort 2: Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs

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    End point title
    Cohort 1 and Cohort 2: Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
    End point description
    An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator as medically significant is reported as an AE. Laboratory evaluations included haematology, serum chemistry, and urinalysis. As-treated population included all participants who received any study drug and were analyzed according to the treatment they received.
    End point type
    Secondary
    End point timeframe
    From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
    End point values
    Placebo Cohort 1 MEDI0382 Cohort 1 Placebo Cohort 2 MEDI0382 Cohort 2
    Number of subjects analysed
    13
    26
    6
    20
    Units: Participants
        Thrombocytopenia
    0
    0
    0
    1
        Hypoglycaemia
    0
    1
    0
    1
    No statistical analyses for this end point

    Secondary: Cohort 1 and Cohort 2: Number of Participants With Injection Site Erythema

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    End point title
    Cohort 1 and Cohort 2: Number of Participants With Injection Site Erythema
    End point description
    The injection site reactions observed during study visits are reported. Injection site reactions included (but are not limited to) local erythema, pain, tenderness, induration, swelling, pruritus, ulceration, and pigmentation. As-treated population included all participants who received any study drug and were analyzed according to the treatment they received.
    End point type
    Secondary
    End point timeframe
    From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
    End point values
    Placebo Cohort 1 MEDI0382 Cohort 1 Placebo Cohort 2 MEDI0382 Cohort 2
    Number of subjects analysed
    13
    26
    6
    20
    Units: Participants
    0
    0
    0
    5
    No statistical analyses for this end point

    Secondary: Cohort 1: Area Under the Concentration-time Curve During the Dosing Interval (AUCt) of MEDI0382

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    End point title
    Cohort 1: Area Under the Concentration-time Curve During the Dosing Interval (AUCt) of MEDI0382 [7]
    End point description
    The area under the concentration-time curve during the dosing interval of MEDI0382 is reported. Pharmacokinetic (PK) population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The 'n' denotes the number of participants analysed for specified time points.
    End point type
    Secondary
    End point timeframe
    Cohort 1: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those baseline period arms for which analysis was planned were reported in the end point.
    End point values
    MEDI0382 Cohort 1
    Number of subjects analysed
    26
    Units: ng*hr/mL
    geometric mean (confidence interval 95%)
        Day 22 (n=18)
    226.31 (103.95 to 488.98)
        Day 49 (n=24)
    248.83 (86.57 to 558.57)
    No statistical analyses for this end point

    Secondary: Cohort 2: Area Under the Concentration-time Curve During the Dosing Interval (AUCt) of MEDI0382

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    End point title
    Cohort 2: Area Under the Concentration-time Curve During the Dosing Interval (AUCt) of MEDI0382 [8]
    End point description
    The area under the concentration-time curve during the dosing interval of MEDI0382 is reported. PK population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The 'n' denotes the number of participants analysed for specified time points.
    End point type
    Secondary
    End point timeframe
    Cohort 2: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those baseline period arms for which analysis was planned were reported in the end point.
    End point values
    MEDI0382 Cohort 2
    Number of subjects analysed
    20
    Units: ng*hr/mL
    geometric mean (confidence interval 95%)
        Day 1 (n=8)
    38.67 (34.05 to 47.25)
        Day 7 (n=13)
    37.51 (8.99 to 69.82)
        Day 14 (n=15)
    46.75 (26.38 to 65.61)
    No statistical analyses for this end point

    Secondary: Cohort 1: Maximum Observed Concentration (Cmax) of MEDI0382

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    End point title
    Cohort 1: Maximum Observed Concentration (Cmax) of MEDI0382 [9]
    End point description
    The maximum observed concentration of MEDI0382 is reported. PK population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The 'n' denotes the number of participants analysed for specified time points.
    End point type
    Secondary
    End point timeframe
    Cohort 1: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those baseline period arms for which analysis was planned were reported in the end point.
    End point values
    MEDI0382 Cohort 1
    Number of subjects analysed
    26
    Units: ng/mL
    geometric mean (confidence interval 95%)
        Day 22 (n=25)
    13.24 (4.89 to 30.3)
        Day 49 (n=24)
    14.8 (5.76 to 33.3)
    No statistical analyses for this end point

    Secondary: Cohort 2: Maximum Observed Concentration (Cmax) of MEDI0382

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    End point title
    Cohort 2: Maximum Observed Concentration (Cmax) of MEDI0382 [10]
    End point description
    The maximum observed concentration of MEDI0382 is reported. PK population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The 'n' denotes the number of participants analysed for specified time points.
    End point type
    Secondary
    End point timeframe
    Cohort 2: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those baseline period arms for which analysis was planned were reported in the end point.
    End point values
    MEDI0382 Cohort 2
    Number of subjects analysed
    20
    Units: ng/mL
    geometric mean (confidence interval 95%)
        Day 1 (n=20)
    2.00 (1.09 to 3.25)
        Day 7 (n=20)
    2.53 (0.85 to 4.14)
        Day 14 (n=19)
    2.65 (1.50 to 3.77)
    No statistical analyses for this end point

    Secondary: Cohort 1: Time to Reach Maximum Observed Concentration (Tmax) of MEDI0382

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    End point title
    Cohort 1: Time to Reach Maximum Observed Concentration (Tmax) of MEDI0382 [11]
    End point description
    The time to reach the maximum observed concentration of MEDI0382 is reported. PK population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The 'n' denotes the number of participants analysed for specified time points.
    End point type
    Secondary
    End point timeframe
    Cohort 1: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those baseline period arms for which analysis was planned were reported in the end point.
    End point values
    MEDI0382 Cohort 1
    Number of subjects analysed
    26
    Units: Hours
    median (full range (min-max))
        Day 22 (n=25)
    6 (4 to 12)
        Day 49 (n=24)
    4 (2 to 8)
    No statistical analyses for this end point

    Secondary: Cohort 2: Time to Reach Maximum Observed Concentration (Tmax) of MEDI0382

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    End point title
    Cohort 2: Time to Reach Maximum Observed Concentration (Tmax) of MEDI0382 [12]
    End point description
    The time to reach the maximum observed concentration of MEDI0382 is reported. PK population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The 'n' denotes the number of participants analysed for specified time points.
    End point type
    Secondary
    End point timeframe
    Cohort 2: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14
    Notes
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those baseline period arms for which analysis was planned were reported in the end point.
    End point values
    MEDI0382 Cohort 2
    Number of subjects analysed
    20
    Units: Hours
    median (full range (min-max))
        Day 1 (n=20)
    8 (4 to 12)
        Day 7 (n=20)
    6 (0 to 8)
        Day 14 (n=19)
    6 (4 to 12)
    No statistical analyses for this end point

    Secondary: Cohort 1: Terminal Half life (t1/2) of MEDI0382

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    End point title
    Cohort 1: Terminal Half life (t1/2) of MEDI0382 [13]
    End point description
    The t1/2 is the time measured for the concentration to decrease by one half after the dose of MEDI0382. The 'n' denotes the number of participants analysed for specified time points. The 95% Confidence Interval cannot be determined as only 1 participant was analysed. Therefore, reported the arbitrary values of 0.99 and 9.99 for lower and upper range of confidence intervals.
    End point type
    Secondary
    End point timeframe
    Cohort 1: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49
    Notes
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those baseline period arms for which analysis was planned were reported in the end point.
    End point values
    MEDI0382 Cohort 1
    Number of subjects analysed
    26
    Units: Hours
    geometric mean (confidence interval 95%)
        Day 22 (n=1)
    9.67 (0.99 to 99.99)
        Day 49 (n=5)
    8.4 (7.7 to 9.4)
    No statistical analyses for this end point

    Secondary: Cohort 2: Terminal Half life (t1/2) of MEDI0382

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    End point title
    Cohort 2: Terminal Half life (t1/2) of MEDI0382 [14]
    End point description
    The t1/2 is the time measured for the concentration to decrease by one half after the dose of MEDI0382. PK population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The 'n' denotes the number of participants analysed for specified time points.
    End point type
    Secondary
    End point timeframe
    Cohort 2: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14
    Notes
    [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those baseline period arms for which analysis was planned were reported in the end point.
    End point values
    MEDI0382 Cohort 2
    Number of subjects analysed
    20
    Units: Hours
    geometric mean (confidence interval 95%)
        Day 1 (n=3)
    9.7 (8.9 to 10.2)
        Day 7 (n=3)
    8.8 (8.6 to 9.0)
        Day 14 (n=4)
    9.4 (8.7 to 10.5)
    No statistical analyses for this end point

    Secondary: Cohort 1: Accumulation Ratio (Ro) of MEDI0382

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    End point title
    Cohort 1: Accumulation Ratio (Ro) of MEDI0382 [15]
    End point description
    The accumulation ratio is defined as the ratio of accumulation of a study drug (AUCt Day i/AUCt Day 1). PK population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The 'n' denotes the number of participants analysed for specified time points. The 95% Confidence Interval was not calculated according to the statistical analysis plan. Therefore, reported by an arbitrary value (99999).
    End point type
    Secondary
    End point timeframe
    Cohort 1: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49
    Notes
    [15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those baseline period arms for which analysis was planned were reported in the end point.
    End point values
    MEDI0382 Cohort 1
    Number of subjects analysed
    26
    Units: Ratio
    geometric mean (confidence interval 95%)
        Day 22 (n=25)
    99999 (99999 to 99999)
        Day 49 (n=24)
    1.5 (1.1 to 3.0)
    No statistical analyses for this end point

    Secondary: Cohort 2: Accumulation Ratio (Ro) of MEDI0382

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    End point title
    Cohort 2: Accumulation Ratio (Ro) of MEDI0382 [16]
    End point description
    The accumulation ratio is defined as the ratio of accumulation of a study drug (AUCt Day i/AUCt Day 1). PK population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The 'n' denotes the number of participants analysed for specified time points. The 95% Confidence Interval was not calculated according to the statistical analysis plan. Therefore, reported by an arbitrary value (99999).
    End point type
    Secondary
    End point timeframe
    Cohort 2: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14
    Notes
    [16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those baseline period arms for which analysis was planned were reported in the end point.
    End point values
    MEDI0382 Cohort 2
    Number of subjects analysed
    20
    Units: Ratio
    geometric mean (confidence interval 95%)
        Day 1 (n=20)
    99999 (99999 to 99999)
        Day 7 (n=13)
    1.4 (1.2 to 1.6)
        Day 14 (n=13)
    1.5 (1.2 to 1.9)
    No statistical analyses for this end point

    Secondary: Cohort 1: Trough Plasma Concentration (Ctrough) of MEDI0382

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    End point title
    Cohort 1: Trough Plasma Concentration (Ctrough) of MEDI0382 [17]
    End point description
    Trough plasma concentration is the measured concentration from the plasma concentration-time data at the end of a dosing interval at steady state. PK population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The 'n' denotes the number of participants analysed for specified time points.
    End point type
    Secondary
    End point timeframe
    Cohort 1: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49
    Notes
    [17] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those baseline period arms for which analysis was planned were reported in the end point.
    End point values
    MEDI0382 Cohort 1
    Number of subjects analysed
    26
    Units: ng/mL
    geometric mean (confidence interval 95%)
        Day 22 (n=25)
    3.566 (0.50 to 9.27)
        Day 49 (n=24)
    5.762 (1.53 to 11.80)
    No statistical analyses for this end point

    Secondary: Cohort 2: Trough Plasma Concentration (Ctrough) of MEDI0382

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    End point title
    Cohort 2: Trough Plasma Concentration (Ctrough) of MEDI0382 [18]
    End point description
    Trough plasma concentration is the measured concentration from the plasma concentration time data at the end of a dosing interval at steady state. For Cohort 2, no participants were analyzed at this time point (n=0) . Therefore, reported by an arbitrary value (99999) which indicates data not available for Day 1 as zero participants were evaluable for this time point (the values were below the limit of quantification for each participant). PK population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The 'n' denotes the number of participants analysed for specified time points.
    End point type
    Secondary
    End point timeframe
    Cohort 2: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14
    Notes
    [18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those baseline period arms for which analysis was planned were reported in the end point.
    End point values
    MEDI0382 Cohort 2
    Number of subjects analysed
    20
    Units: ng/mL
    geometric mean (confidence interval 95%)
        Day 1 (n=0)
    99999 (99999 to 99999)
        Day 7 (n=19)
    1.147 (0.79 to 2.36)
        Day 14 (n=19)
    1.147 (0.69 to 1.92)
    No statistical analyses for this end point

    Secondary: Cohort 1 and Cohort 2: Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI0382

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    End point title
    Cohort 1 and Cohort 2: Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI0382
    End point description
    Participants with positive serum antibodies to MEDI0382 are reported. As-treated population included all participants who received any study drug and were analyzed according to the treatment they received. The 'n' denotes the number of participants analysed for specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), Day 29, Day 50, and Follow-up Visit 2 (28 days after the last dose [approximately 64 days])
    End point values
    Placebo Cohort 1 MEDI0382 Cohort 1 Placebo Cohort 2 MEDI0382 Cohort 2
    Number of subjects analysed
    13
    26
    6
    20
    Units: Participants
        Baseline (ADA positive) (n=13, 26, 6, 20)
    0
    0
    0
    0
        Day 29 (ADA positive) (n=13, 26, 6, 18)
    0
    4
    0
    1
        Day 50 (ADA positive) (n=13, 25, 6, 18)
    0
    7
    0
    2
        Follow-up Visit 2 (ADA positive) (n=13, 24, 6, 20)
    1
    6
    0
    6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Placebo Cohort 1
    Reporting group description
    Participants received placebo matching with MEDI0382 subcutaneously (SC) once daily for 49 days.

    Reporting group title
    MEDI0382 Cohort 1
    Reporting group description
    Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.

    Reporting group title
    Placebo Cohort 2
    Reporting group description
    Participants received placebo matching with MEDI0382 SC once daily for 49 days.

    Reporting group title
    MEDI0382 Cohort 2
    Reporting group description
    Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.

    Serious adverse events
    Placebo Cohort 1 MEDI0382 Cohort 1 Placebo Cohort 2 MEDI0382 Cohort 2
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 26 (0.00%)
    0 / 6 (0.00%)
    0 / 20 (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
    Placebo Cohort 1 MEDI0382 Cohort 1 Placebo Cohort 2 MEDI0382 Cohort 2
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 13 (46.15%)
    22 / 26 (84.62%)
    3 / 6 (50.00%)
    15 / 20 (75.00%)
    General disorders and administration site conditions
    Face oedema
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 26 (3.85%)
    0 / 6 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Fatigue
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 26 (3.85%)
    0 / 6 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Injection site erythema
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 26 (0.00%)
    0 / 6 (0.00%)
    5 / 20 (25.00%)
         occurrences all number
    0
    0
    0
    7
    Induration
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 26 (0.00%)
    0 / 6 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    Injection site haematoma
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 26 (0.00%)
    0 / 6 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    Injection site reaction
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 26 (0.00%)
    0 / 6 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    2
    Malaise
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 26 (3.85%)
    0 / 6 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Medical device site pain
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 26 (3.85%)
    0 / 6 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Medical device site swelling
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 26 (3.85%)
    0 / 6 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Oedema peripheral
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 26 (3.85%)
    0 / 6 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pyrexia
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 26 (3.85%)
    0 / 6 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Vessel puncture site haematoma
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 26 (3.85%)
    0 / 6 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Psychiatric disorders
    Loss of libido
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 26 (3.85%)
    0 / 6 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Reproductive system and breast disorders
    Vaginal haemorrhage
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 26 (0.00%)
    1 / 6 (16.67%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 26 (0.00%)
    0 / 6 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Procedural nausea
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 26 (3.85%)
    0 / 6 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 26 (0.00%)
    0 / 6 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 26 (3.85%)
    0 / 6 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Cough
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 26 (3.85%)
    1 / 6 (16.67%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Nasal obstruction
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 26 (0.00%)
    1 / 6 (16.67%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 26 (3.85%)
    0 / 6 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    0
    1
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 26 (0.00%)
    0 / 6 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 26 (3.85%)
    0 / 6 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    0
    1
    Headache
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 26 (7.69%)
    2 / 6 (33.33%)
    4 / 20 (20.00%)
         occurrences all number
    0
    2
    2
    6
    Tremor
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 26 (0.00%)
    0 / 6 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    5
    Eye disorders
    Visual impairment
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 26 (0.00%)
    0 / 6 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 26 (0.00%)
    0 / 6 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    Abdominal pain
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 26 (3.85%)
    0 / 6 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Abdominal wall haematoma
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 26 (0.00%)
    0 / 6 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Constipation
         subjects affected / exposed
    0 / 13 (0.00%)
    4 / 26 (15.38%)
    0 / 6 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    4
    0
    1
    Diarrhoea
         subjects affected / exposed
    1 / 13 (7.69%)
    3 / 26 (11.54%)
    0 / 6 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    4
    0
    1
    Dyspepsia
         subjects affected / exposed
    0 / 13 (0.00%)
    4 / 26 (15.38%)
    0 / 6 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    8
    0
    3
    Eructation
         subjects affected / exposed
    0 / 13 (0.00%)
    3 / 26 (11.54%)
    0 / 6 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    4
    0
    0
    Flatulence
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 26 (3.85%)
    0 / 6 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nausea
         subjects affected / exposed
    0 / 13 (0.00%)
    5 / 26 (19.23%)
    0 / 6 (0.00%)
    7 / 20 (35.00%)
         occurrences all number
    0
    8
    0
    11
    Parotid gland enlargement
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 26 (0.00%)
    0 / 6 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    Regurgitation
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 26 (0.00%)
    0 / 6 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    Tongue discomfort
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 26 (0.00%)
    0 / 6 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    2
    Toothache
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 26 (7.69%)
    0 / 6 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    3
    0
    1
    Vomiting
         subjects affected / exposed
    0 / 13 (0.00%)
    3 / 26 (11.54%)
    0 / 6 (0.00%)
    4 / 20 (20.00%)
         occurrences all number
    0
    6
    0
    11
    Renal and urinary disorders
    Nocturia
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 26 (3.85%)
    0 / 6 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Dermatitis contact
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 26 (3.85%)
    0 / 6 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Erythema
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 26 (0.00%)
    0 / 6 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    Hyperhidrosis
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 26 (0.00%)
    0 / 6 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    Rash
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 26 (3.85%)
    0 / 6 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Skin reaction
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 26 (3.85%)
    0 / 6 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 26 (0.00%)
    1 / 6 (16.67%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Pain in extremity
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 26 (3.85%)
    0 / 6 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Osteoarthritis
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 26 (3.85%)
    0 / 6 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Metabolism and nutrition disorders
    Gout
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 26 (3.85%)
    0 / 6 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Decreased appetite
         subjects affected / exposed
    2 / 13 (15.38%)
    13 / 26 (50.00%)
    0 / 6 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    2
    17
    0
    0
    Hypoglycaemia
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 26 (3.85%)
    0 / 6 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    0
    1
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 26 (0.00%)
    0 / 6 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    Nasal herpes
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 26 (3.85%)
    0 / 6 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Rhinitis
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 26 (3.85%)
    0 / 6 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 26 (0.00%)
    0 / 6 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    0
    0
    2
    Viral upper respiratory tract infection
         subjects affected / exposed
    3 / 13 (23.08%)
    3 / 26 (11.54%)
    0 / 6 (0.00%)
    3 / 20 (15.00%)
         occurrences all number
    4
    4
    0
    4

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Jul 2017
    The original protocol was amended to modify exploratory objectives, clinical laboratory test, exclusion criteria, procedures, prohibited concomitant medications, reduction in blood volume, and to correct typographical errors.
    17 Oct 2017
    The protocol amendment 2 was made to modify the procedures, table footnotes, time frame for serious adverse events, updated with the definition of postmenopausal to correct a previous oversight, and clarification on maternal exposure.

    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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