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    Clinical Trial Results:
    An Open Label, Randomized, Crossover, Single Dose Bioavailability Study in Healthy Adult Subjects to Evaluate the Pharmacokinetic Profile of an Exploratory Avacopan Pediatric Liquid Formulation Compared to Avacopan 10 mg Capsule Formulation

    Summary
    EudraCT number
    		 2023-000381-34
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    15 Aug 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Aug 2023
    First version publication date
    25 Aug 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CL019_168
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 IND: 120784
    Sponsors
    Sponsor organisation name
    ChemoCentryx
    Sponsor organisation address
    850 Maude Avenue, Mountain View, California, United States, 94043
    Public contact
    Study Director, Amgen Inc, +1 8665726436, medinfo@amgen.com
    Scientific contact
    Study Director, Amgen Inc, +1 8665726436, medinfo@amgen.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-002023-PIP01-16
    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
    14 Feb 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Aug 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Assess the pharmacokinetics (PK) of an exploratory pediatric liquid formulation of avacopan given under fasted and fed conditions compared to an avacopan capsule formulation given under fasted or fed conditions
    Protection of trial subjects
    Celerion attests that the clinical portion of this study was performed in compliance with Celerion Standard Operating Procedures (SOPs). The SOPs are written based on the principles and requirements of GCP as defined by the regulatory agencies standards and guidance listed in the Celerion Global Quality Manual. These SOPs are also in accordance with the ethical requirements referred to in the European Union (EU) directive 2001/20/EC and the ethical principles set forth in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Mar 2022
    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: 31
    Worldwide total number of subjects
    31
    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)
    31
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Subjects reported to the clinical research unit (CRU) for eligibility screening within approximately 3 weeks prior to the first drug administration.

    Period 1
    Period 1 title
    Stage 1
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    This was an open-label study. Subjects were randomized to treatment sequences to minimize assignment bias. Because the primary endpoints of this study were objective PK measurements, blinding was not necessary. A crossover design was used to control for the variability between subjects. A 10-day washout between doses was considered sufficient to eliminate carry-over effects of the treatments.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Treatment A
    Arm description
    		 30 mg Avacopan liquid formulation fasted
    Arm type
    		 Experimental

    Investigational medicinal product name
    Avacopan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    A single oral dose of 30 mg avacopan liquid formulation (5 mL of 6 mg/mL). The study drugs were administered orally with 240 mL of water under fasted conditions

    Arm title
    		 Treatment B
    Arm description
    		 30 mg Avacopan liquid formulation fed
    Arm type
    		 Experimental

    Investigational medicinal product name
    Avacopan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    A single oral dose of 30 mg avacopan liquid formulation (5 mL of 6 mg/mL). The study drugs were administered orally with 240 mL of water under fed conditions

    Arm title
    		 Treatment C
    Arm description
    		 30 mg Avacopan capsules fasted
    Arm type
    		 Experimental

    Investigational medicinal product name
    Avacopan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    The avacopan capsules contained 10 mg avacopan. A single oral dose of 30 mg avacopan (3 x 10 mg capsules) under fasted conditions.

    Number of subjects in period 1
    		Treatment A Treatment B Treatment C
    Started
    15
    15
    15
    Completed
    15
    15
    15
    Period 2
    Period 2 title
    Stage 2
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    This was a open label study. Subjects were randomized to treatment sequences to minimize assignment bias. Because the primary endpoints of this study were objective PK measurements, blinding was not necessary. A crossover design was used to control for the variability between subjects. A 10-day washout between doses was considered sufficient to eliminate carry-over effects of the treatments.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treatment D
    Arm description
    		 30 mg avacopan liquid formulation fed, high fat, high calorie food. The total number of subjects reflects 8 subjects who started on treatment D and crossed over to treatment E, and 8 subjects who started on treatment E and crossed over to treatment D, and .
    Arm type
    		 Experimental

    Investigational medicinal product name
    Avacopan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    A single oral dose of 30 mg avacopan liquid formulation (5 mL of 6 mg/mL). The study drugs were administered orally with 240 mL of water

    Arm title
    		 Treatment E
    Arm description
    		 30 mg avacopan liquid formulation fed, low fat, low calorie food. The total number of subjects reflects 8 subjects who started on treatment E and crossed over to treatment D, and 8 subjects who started on treatment D and crossed over to treatment E.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Avacopan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    A single oral dose of 30 mg avacopan liquid formulation (5 mL of 6 mg/mL). The study drugs were administered orally with 240 mL of water

    Number of subjects in period 2
    		Treatment D Treatment E
    Started
    16
    16
    Completed
    16
    16

    Baseline characteristics

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    Baseline characteristics reporting groups [1]
    Reporting group title
    Stage 1
    Reporting group description
    		 Baseline characteristics for the safety population involved in stage 1. The safety population included all randomized subjects who received at least 1 dose of the study drug.

    Notes
    [1] - The number of subjects reported to be in the baseline period is not equal to the worldwide number of subjects enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Stage 1 and stage 2 baseline characteristics are captured separately
    Reporting group values
    		 Stage 1 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)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 15 15
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 38.5 ± 10.41 -
    Gender categorical
    Units: Subjects
        Female
    		 9 9
        Male
    		 6 6
    Race
    Units: Subjects
        White
    		 15 15
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 10 10
        Not Hispanic or Latino
    		 5 5
    Weight
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    		 72.753 ± 13.2988 -
    Height
    Units: centimetre
        arithmetic mean (standard deviation)
    		 166.1 ± 10.41 -
    Body Mass Index
    Units: kilogram(s)/square metre
        arithmetic mean (standard deviation)
    		 26.24 ± 3.171 -
    Subject analysis sets

    Subject analysis set title
    Stage 2
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Baseline characteristics for the safety population involved in stage 2. The safety population included all randomized subjects who received at east 1 dose of the study drug.

    Subject analysis sets values
    		 Stage 2
    Number of subjects
    16
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    16
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    38.8 ± 11.29
    Gender categorical
    Units: Subjects
        Female
    10
        Male
    6
    Race
    Units: Subjects
        White
    15
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    16
        Not Hispanic or Latino
    Weight
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    76.806 ± 15.2264
    Height
    Units: centimetre
        arithmetic mean (standard deviation)
    166.8 ± 8.90
    Body Mass Index
    Units: kilogram(s)/square metre
        arithmetic mean (standard deviation)
    27.48 ± 3.949

    End points

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    End points reporting groups
    Reporting group title
    Treatment A
    Reporting group description
    		 30 mg Avacopan liquid formulation fasted

    Reporting group title
    Treatment B
    Reporting group description
    		 30 mg Avacopan liquid formulation fed

    Reporting group title
    Treatment C
    Reporting group description
    		 30 mg Avacopan capsules fasted
    Reporting group title
    Treatment D
    Reporting group description
    		 30 mg avacopan liquid formulation fed, high fat, high calorie food. The total number of subjects reflects 8 subjects who started on treatment D and crossed over to treatment E, and 8 subjects who started on treatment E and crossed over to treatment D, and .

    Reporting group title
    Treatment E
    Reporting group description
    		 30 mg avacopan liquid formulation fed, low fat, low calorie food. The total number of subjects reflects 8 subjects who started on treatment E and crossed over to treatment D, and 8 subjects who started on treatment D and crossed over to treatment E.

    Subject analysis set title
    Stage 2
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Baseline characteristics for the safety population involved in stage 2. The safety population included all randomized subjects who received at east 1 dose of the study drug.

    Primary: Area under the plasma concentration-time curve from Time 0 to 24h of Avacopan in Plasma for the Overall Trial

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    End point title
    		 Area under the plasma concentration-time curve from Time 0 to 24h of Avacopan in Plasma for the Overall Trial [1]
    End point description
    Area under the plasma concentration-time curve from Time 0 to 24h of Avacopan in Plasma for the overall trial
    End point type
    Primary
    End point timeframe
    Baseline to end of study
    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: No statistical analysis has been performed on pharmacokinetic endpoints.
    End point values
    		 Treatment A Treatment B Treatment C Treatment D Treatment E
    Number of subjects analysed
    9
    15
    15
    16
    16
    Units: ng*hr/mL
        geometric mean (geometric coefficient of variation)
    85.84 ± 87.8
    840.1 ± 37.4
    607.3 ± 45.5
    958.5 ± 31.2
    919.9 ± 31.0
    No statistical analyses for this end point

    Primary: Area under the plasma concentration-time curve from Time 0 to 72h of Avacopan in Plasma for the Overall trial

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    End point title
    		 Area under the plasma concentration-time curve from Time 0 to 72h of Avacopan in Plasma for the Overall trial [2]
    End point description
    Area under the plasma concentration-time curve from Time 0 to 72h of Avacopan in Plasma for overall trial
    End point type
    Primary
    End point timeframe
    Baseline to end of study
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis has been performed on pharmacokinetic endpoints.
    End point values
    		 Treatment A Treatment B Treatment C Treatment D Treatment E
    Number of subjects analysed
    8
    15
    15
    16
    16
    Units: ng*hr/mL
        geometric mean (geometric coefficient of variation)
    129.9 ± 78.9
    1008 ± 37.4
    707.9 ± 49.5
    1146 ± 30.4
    1097 ± 32.4
    No statistical analyses for this end point

    Primary: Area under the plasma concentration-time curve from Time 0 to last of Avacopan in Plasma for the Overall trial

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    End point title
    		 Area under the plasma concentration-time curve from Time 0 to last of Avacopan in Plasma for the Overall trial [3]
    End point description
    Area under the plasma concentration-time curve from Time 0 to last of Avacopan in Plasma for the Overall trial
    End point type
    Primary
    End point timeframe
    Baseline to end of study
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis has been performed on pharmacokinetic endpoints.
    End point values
    		 Treatment A Treatment B Treatment C Treatment D Treatment E
    Number of subjects analysed
    11
    15
    15
    16
    16
    Units: ng*hr/mL
        geometric mean (geometric coefficient of variation)
    75.52 ± 137.0
    1142 ± 41.2
    763.4 ± 61.0
    1329 ± 31.4
    1241 ± 37.9
    No statistical analyses for this end point

    Primary: Area under the plasma concentration-time curve from Time 0 to Infinity of Avacopan in Plasma for the Overall trial

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    End point title
    		 Area under the plasma concentration-time curve from Time 0 to Infinity of Avacopan in Plasma for the Overall trial [4]
    End point description
    Area under the plasma concentration-time curve from Time 0 to Infinity of Avacopan in Plasma for Overall trial
    End point type
    Primary
    End point timeframe
    Baseline to end of study
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis has been performed on pharmacokinetic endpoints.
    End point values
    		 Treatment A Treatment B Treatment C Treatment D Treatment E
    Number of subjects analysed
    7
    15
    15
    16
    16
    Units: ng*hr/mL
        geometric mean (geometric coefficient of variation)
    140.4 ± 106.8
    1391 ± 44.7
    898.1 ± 71.1
    1589 ± 32.5
    1477 ± 39.7
    No statistical analyses for this end point

    Primary: Maximum Plasma Concentration (Cmax) of Avacopan in the Overall trial

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    End point title
    		 Maximum Plasma Concentration (Cmax) of Avacopan in the Overall trial [5]
    End point description
    Maximum Plasma Concentration (Cmax) of Avacopan for the overall trial
    End point type
    Primary
    End point timeframe
    Baseline to end of study
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis has been performed on pharmacokinetic endpoints.
    End point values
    		 Treatment A Treatment B Treatment C Treatment D Treatment E
    Number of subjects analysed
    11
    15
    15
    16
    16
    Units: ng/mL
        geometric mean (geometric coefficient of variation)
    6.661 ± 138.0
    110.3 ± 43.0
    128.1 ± 33.4
    127.6 ± 24.2
    130.6 ± 24.1
    No statistical analyses for this end point

    Primary: Time to maximum Concentration (Tmax) of Avacopan for the Overall trial

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    End point title
    		 Time to maximum Concentration (Tmax) of Avacopan for the Overall trial [6]
    End point description
    Time to maximum Concentration (Tmax) of Avacopan for the Overall trial
    End point type
    Primary
    End point timeframe
    Baseline to end of study
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis has been performed on pharmacokinetic endpoints.
    End point values
    		 Treatment A Treatment B Treatment C Treatment D Treatment E
    Number of subjects analysed
    11
    15
    15
    16
    16
    Units: hour
        median (full range (min-max))
    5.999 (3.00 to 12.03)
    6.000 (2.01 to 8.06)
    1.527 (1.50 to 2.50)
    4.000 (1.50 to 8.06)
    4.001 (2.00 to 8.05)
    No statistical analyses for this end point

    Primary: Area under the plasma concentration-time curve from Time 0 to 24h of Avacopan M1 metabolite in Plasma for the Overall trial

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    End point title
    		 Area under the plasma concentration-time curve from Time 0 to 24h of Avacopan M1 metabolite in Plasma for the Overall trial [7]
    End point description
    Area under the plasma concentration-time curve from Time 0 to 24h of Avacopan M1 metabolite in Plasma for the overall trial
    End point type
    Primary
    End point timeframe
    Baseline to end of study
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis has been performed on pharmacokinetic endpoints.
    End point values
    		 Treatment A Treatment B Treatment C Treatment D Treatment E
    Number of subjects analysed
    7
    15
    15
    15
    16
    Units: ng*hr/mL
        geometric mean (geometric coefficient of variation)
    54.50 ± 55.6
    296.8 ± 18.8
    381.4 ± 24.8
    311.9 ± 15.9
    320.2 ± 19.2
    No statistical analyses for this end point

    Primary: Area under the plasma concentration-time curve from Time 0 to 72h of Avacopan M1 Metabolite in Plasma for the Overall trial

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    End point title
    		 Area under the plasma concentration-time curve from Time 0 to 72h of Avacopan M1 Metabolite in Plasma for the Overall trial [8]
    End point description
    Area under the plasma concentration-time curve from Time 0 to 72h of Avacopan M1 Metabolite in Plasma for the Overall trial
    End point type
    Primary
    End point timeframe
    Baseline to end of study
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis has been performed on pharmacokinetic endpoints.
    End point values
    		 Treatment A Treatment B Treatment C Treatment D Treatment E
    Number of subjects analysed
    6
    15
    15
    15
    15
    Units: ng*hr/mL
        geometric mean (geometric coefficient of variation)
    93.23 ± 75.2
    493.4 ± 20.9
    563.5 ± 27.4
    501.5 ± 17.3
    519.5 ± 23.5
    No statistical analyses for this end point

    Primary: Area under the plasma concentration-time curve from Time 0 to last of Avacopan M1 Metabolite in Plasma for the Overall Trial

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    End point title
    		 Area under the plasma concentration-time curve from Time 0 to last of Avacopan M1 Metabolite in Plasma for the Overall Trial [9]
    End point description
    Area under the plasma concentration-time curve from Time 0 to last of Avacopan M1 Metabolite in Plasma for the Overall trial
    End point type
    Primary
    End point timeframe
    Baseline to End of Study
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis has been performed on pharmacokinetic endpoints.
    End point values
    		 Treatment A Treatment B Treatment C Treatment D Treatment E
    Number of subjects analysed
    14
    15
    15
    15
    16
    Units: ng*hr/mL
        geometric mean (geometric coefficient of variation)
    25.20 ± 250.7
    585.7 ± 35.5
    647.6 ± 40.7
    623.8 ± 23.6
    645.2 ± 32.4
    No statistical analyses for this end point

    Primary: Area under the plasma concentration-time curve from Time 0 to Infinity of Avacopan M1 Metabolite in Plasma for the Overall trial

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    End point title
    		 Area under the plasma concentration-time curve from Time 0 to Infinity of Avacopan M1 Metabolite in Plasma for the Overall trial [10]
    End point description
    Area under the plasma concentration-time curve from Time 0 to Infinity of Avacopan M1 Metabolite in Plasma for the Overall trial
    End point type
    Primary
    End point timeframe
    Baseline to end of study
    Notes
    [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis has been performed on pharmacokinetic endpoints.
    End point values
    		 Treatment A Treatment B Treatment C Treatment D Treatment E
    Number of subjects analysed
    5
    15
    15
    15
    16
    Units: ng*hr/mL
        geometric mean (geometric coefficient of variation)
    104.6 ± 120.1
    706.7 ± 28.0
    758.0 ± 38.3
    738.5 ± 21.8
    763.3 ± 31.1
    No statistical analyses for this end point

    Primary: Maximum Plasma Concentration (Cmax) of Avacopan M1 Metabolite in the Overall trial

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    End point title
    		 Maximum Plasma Concentration (Cmax) of Avacopan M1 Metabolite in the Overall trial [11]
    End point description
    Maximum Plasma Concentration (Cmax) of Avacopan M1 Metabolite in the Overall trial
    End point type
    Primary
    End point timeframe
    Baseline to end of study
    Notes
    [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis has been performed on pharmacokinetic endpoints.
    End point values
    		 Treatment A Treatment B Treatment C Treatment D Treatment E
    Number of subjects analysed
    14
    15
    15
    15
    16
    Units: ng/mL
        geometric mean (geometric coefficient of variation)
    3.090 ± 84.3
    24.36 ± 23.0
    51.48 ± 23.6
    25.60 ± 12.3
    28.82 ± 19.4
    No statistical analyses for this end point

    Primary: Time to maximum Concentration (Tmax) of Avacopan M1 Metabolite in the Overall trial

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    End point title
    		 Time to maximum Concentration (Tmax) of Avacopan M1 Metabolite in the Overall trial [12]
    End point description
    Time to maximum Concentration (Tmax) of Avacopan M1 Metabolite in the Overall trial
    End point type
    Primary
    End point timeframe
    Baseline to end of study
    Notes
    [12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis has been performed on pharmacokinetic endpoints.
    End point values
    		 Treatment A Treatment B Treatment C Treatment D Treatment E
    Number of subjects analysed
    14
    15
    15
    15
    16
    Units: hour
        median (full range (min-max))
    5.998 (4.00 to 8.01)
    7.998 (2.99 to 8.06)
    2.500 (1.52 to 3.02)
    5.997 (3.00 to 8.06)
    5.999 (3.00 to 8.05)
    No statistical analyses for this end point

    Secondary: Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) during the trial

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    End point title
    		 Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) during the trial
    End point description
    Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) during the trial
    End point type
    Secondary
    End point timeframe
    Baseline to end of study
    End point values
    		 Treatment A Treatment B Treatment C Treatment D Treatment E
    Number of subjects analysed
    15
    15
    15
    8
    8
    Units: Number
        TEAEs
    2
    2
    1
    1
    4
        SAEs
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline to end of study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Treatment A
    Reporting group description
    		 30 mg Avacopan liquid formulation fasted

    Reporting group title
    Treatment B
    Reporting group description
    		 30 mg Avacopan liquid formulation fed

    Reporting group title
    Treatment C
    Reporting group description
    		 30 mg Avacopan capsules fasted

    Reporting group title
    Treatment D
    Reporting group description
    		 30 mg avacopan liquid formulation fed, high fat, high calorie food

    Reporting group title
    Treatment E
    Reporting group description
    		 30 mg avacopan liquid formulation fed, low fat, low calorie food

    Serious adverse events
    		 Treatment A Treatment B Treatment C Treatment D Treatment E
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Treatment A Treatment B Treatment C Treatment D Treatment E
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 15 (13.33%)
    2 / 15 (13.33%)
    1 / 15 (6.67%)
    1 / 16 (6.25%)
    4 / 16 (25.00%)
    Investigations
    Heart rate increased
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Injury, poisoning and procedural complications
    Sunburn
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    1
    Headache
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    1
    General disorders and administration site conditions
    Vessel puncture site bruise
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Vessel puncture site pain
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Gastrointestinal disorders
    Lip scab
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Abdominal distension
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    1
    Constipation
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    1
    Flatulence
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    1
    Nausea
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    1
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Apr 2022
    Clarity to staging timings, footnote corrections, inclusion criteria for men and women updated from 90 to 120 days, removal of the need to have a seated or supine blood test for PK samples, clarity for healthy subjects. Consistency made throughout, clarity added and corrections made throughout.
    14 Jun 2022
    Consistency made throughout, clarity added and corrections made throughout.

    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
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