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    Clinical Trial Results:
    Phase 2 Study of the Safety and Efficacy of CORT125134 in the Treatment of Endogenous Cushing’s Syndrome

    Summary
    EudraCT number
    		 2016-000899-23
    Trial protocol
    		 GB   HU   NL   IT  
    Global end of trial date
    24 Sep 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Jan 2020
    First version publication date
    31 Jan 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CORT125134-451
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02804750
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 128625: IND Number
    Sponsors
    Sponsor organisation name
    Corcept Therapeutics
    Sponsor organisation address
    149 Commonwealth Drive, Menlo Park, United States, 94025
    Public contact
    Medical Director, Corcept Therapeutics, +1 650 327 3270, info@corcept.com
    Scientific contact
    Medical Director, Corcept Therapeutics, +1 650 327 3270, info@corcept.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
    24 Sep 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Sep 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study was to evaluate the safety and efficacy of CORT125134 for treatment of endogenous Cushing's syndrome. The multicenter study was conducted in the United States and in Europe.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Jun 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 2
    Country: Number of subjects enrolled
    United Kingdom: 2
    Country: Number of subjects enrolled
    Hungary: 5
    Country: Number of subjects enrolled
    United States: 12
    Country: Number of subjects enrolled
    Italy: 14
    Worldwide total number of subjects
    35
    EEA total number of subjects
    23
    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)
    32
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Participants were screened up to 6 weeks before Day 1. A total of 67 participants were screened and 35 were enrolled.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1: Low-dose Group
    Arm description
    		 100 mg/day for 4 weeks in Period 1, then 150 mg/day for 4 weeks in Period 2, then 200 mg/day for 4 weeks in Period 3. There was no washout between treatment periods. Period 3 was followed by a 4-week follow-up period. Per-protocol, Group 1 did not participate in treatment Period 4.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CORT125134
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    CORT125134 50 mg capsules for oral administration

    Arm title
    		 Group 2: High-dose Group
    Arm description
    		 250 mg/day for 4 weeks in Period 1, then 300 mg/day for 4 weeks in Period 2, then 350 mg/day for 4 weeks in Period 3, then 400 mg/day for 4 weeks in Period 4. There was no washout between treatment periods. Period 4 was followed by a 4-week follow-up period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CORT125134
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    CORT125134 50 mg capsules for oral administration

    Number of subjects in period 1
    		Group 1: Low-dose Group Group 2: High-dose Group
    Started
    17
    18
    Completed
    17
    15
    Not completed
    0
    3
         Consent withdrawn by subject
    -
    1
         Adverse event, non-fatal
    -
    2
    Period 2
    Period 2 title
    Period 2
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1: Low-dose Group
    Arm description
    		 100 mg/day for 4 weeks in Period 1, then 150 mg/day for 4 weeks in Period 2, then 200 mg/day for 4 weeks in Period 3. There was no washout between treatment periods. Period 3 was followed by a 4-week follow-up period. Per-protocol, Group 1 did not participate in treatment Period 4.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CORT125134
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    CORT125134 50 mg capsules for oral administration

    Arm title
    		 Group 2: High-dose Group
    Arm description
    		 250 mg/day for 4 weeks in Period 1, then 300 mg/day for 4 weeks in Period 2, then 350 mg/day for 4 weeks in Period 3, then 400 mg/day for 4 weeks in Period 4. There was no washout between treatment periods. Period 4 was followed by a 4-week follow-up period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CORT125134
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    CORT125134 50 mg capsules for oral administration

    Number of subjects in period 2
    		Group 1: Low-dose Group Group 2: High-dose Group
    Started
    17
    15
    Completed
    16
    15
    Not completed
    1
    0
         Adverse event, non-fatal
    1
    -
    Period 3
    Period 3 title
    Period 3
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1: Low-dose Group
    Arm description
    		 100 mg/day for 4 weeks in Period 1, then 150 mg/day for 4 weeks in Period 2, then 200 mg/day for 4 weeks in Period 3. There was no washout between treatment periods. Period 3 was followed by a 4-week follow-up period. Per-protocol, Group 1 did not participate in treatment Period 4.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CORT125134
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    CORT125134 50 mg capsules for oral administration

    Arm title
    		 Group 2: High-dose Group
    Arm description
    		 250 mg/day for 4 weeks in Period 1, then 300 mg/day for 4 weeks in Period 2, then 350 mg/day for 4 weeks in Period 3, then 400 mg/day for 4 weeks in Period 4. There was no washout between treatment periods. Period 4 was followed by a 4-week follow-up period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CORT125134
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    CORT125134 50 mg capsules for oral administration

    Number of subjects in period 3
    		Group 1: Low-dose Group Group 2: High-dose Group
    Started
    16
    15
    Completed
    16
    13
    Not completed
    0
    2
         Adverse event, non-fatal
    -
    2
    Period 4
    Period 4 title
    Period 4
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Group 2: High-dose Group
    Arm description
    		 250 mg/day for 4 weeks in Period 1, then 300 mg/day for 4 weeks in Period 2, then 350 mg/day for 4 weeks in Period 3, then 400 mg/day for 4 weeks in Period 4. There was no washout between treatment periods. Period 4 was followed by a 4-week follow-up period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CORT125134
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    CORT125134 50 mg capsules for oral administration

    Number of subjects in period 4 [1]
    		Group 2: High-dose Group
    Started
    12
    Completed
    7
    Not completed
    5
         Adverse event, non-fatal
    5
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Per protocol, Group 1 did not participate in Period 4. One participant in Group 2 completed Period 3 but did not start Period 4 due to a pre-scheduled surgery. This participant is considered to have completed the study; this patient did not sign Protocol Version 7.0 allowing CORT125134 dosing at 400 mg.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1: Low-dose Group
    Reporting group description
    		 100 mg/day for 4 weeks in Period 1, then 150 mg/day for 4 weeks in Period 2, then 200 mg/day for 4 weeks in Period 3. There was no washout between treatment periods. Period 3 was followed by a 4-week follow-up period. Per-protocol, Group 1 did not participate in treatment Period 4.

    Reporting group title
    Group 2: High-dose Group
    Reporting group description
    		 250 mg/day for 4 weeks in Period 1, then 300 mg/day for 4 weeks in Period 2, then 350 mg/day for 4 weeks in Period 3, then 400 mg/day for 4 weeks in Period 4. There was no washout between treatment periods. Period 4 was followed by a 4-week follow-up period.

    Reporting group values
    		 Group 1: Low-dose Group Group 2: High-dose Group Total
    Number of subjects
    		 17 18 35
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 15 17 32
        From 65-84 years
    		 2 1 3
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 47.6 ( 13.62 ) 49.5 ( 13.46 ) -
    Gender categorical
    Units: Subjects
        Female
    		 9 16 25
        Male
    		 8 2 10
    Hypertension
    Confirmed with a mean systolic blood pressure (BP) of 130-170 mmHg and/or a mean diastolic BP of 85-110 mmHg based on the 24-hour ambulatory BP measurement.
    Units: Subjects
        Hypertension
    		 12 11 23
        No hypertension
    		 5 7 12
    Impaired Glucose Tolerance (IGT) / Type-2 Diabetes Mellitus (T2DM)
    Either a fasting glucose > 126 mg/dL and a 2-hour Oral Glucose Tolerance Test (oGTT) result for plasma glucose ≥ 200 mg/dL at 2 hours (for T2DM), or a 2-hour oGTT result for plasma glucose in the range of ≥ 140 mg/dL to < 200 mg/dL (for IGT).
    Units: Subjects
        IGT / T2DM
    		 13 15 28
        No IGT / T2DM
    		 4 3 7

    End points

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    End points reporting groups
    Reporting group title
    Group 1: Low-dose Group
    Reporting group description
    		 100 mg/day for 4 weeks in Period 1, then 150 mg/day for 4 weeks in Period 2, then 200 mg/day for 4 weeks in Period 3. There was no washout between treatment periods. Period 3 was followed by a 4-week follow-up period. Per-protocol, Group 1 did not participate in treatment Period 4.

    Reporting group title
    Group 2: High-dose Group
    Reporting group description
    		 250 mg/day for 4 weeks in Period 1, then 300 mg/day for 4 weeks in Period 2, then 350 mg/day for 4 weeks in Period 3, then 400 mg/day for 4 weeks in Period 4. There was no washout between treatment periods. Period 4 was followed by a 4-week follow-up period.
    Reporting group title
    Group 1: Low-dose Group
    Reporting group description
    		 100 mg/day for 4 weeks in Period 1, then 150 mg/day for 4 weeks in Period 2, then 200 mg/day for 4 weeks in Period 3. There was no washout between treatment periods. Period 3 was followed by a 4-week follow-up period. Per-protocol, Group 1 did not participate in treatment Period 4.

    Reporting group title
    Group 2: High-dose Group
    Reporting group description
    		 250 mg/day for 4 weeks in Period 1, then 300 mg/day for 4 weeks in Period 2, then 350 mg/day for 4 weeks in Period 3, then 400 mg/day for 4 weeks in Period 4. There was no washout between treatment periods. Period 4 was followed by a 4-week follow-up period.
    Reporting group title
    Group 1: Low-dose Group
    Reporting group description
    		 100 mg/day for 4 weeks in Period 1, then 150 mg/day for 4 weeks in Period 2, then 200 mg/day for 4 weeks in Period 3. There was no washout between treatment periods. Period 3 was followed by a 4-week follow-up period. Per-protocol, Group 1 did not participate in treatment Period 4.

    Reporting group title
    Group 2: High-dose Group
    Reporting group description
    		 250 mg/day for 4 weeks in Period 1, then 300 mg/day for 4 weeks in Period 2, then 350 mg/day for 4 weeks in Period 3, then 400 mg/day for 4 weeks in Period 4. There was no washout between treatment periods. Period 4 was followed by a 4-week follow-up period.
    Reporting group title
    Group 2: High-dose Group
    Reporting group description
    		 250 mg/day for 4 weeks in Period 1, then 300 mg/day for 4 weeks in Period 2, then 350 mg/day for 4 weeks in Period 3, then 400 mg/day for 4 weeks in Period 4. There was no washout between treatment periods. Period 4 was followed by a 4-week follow-up period.

    Primary: Percentage of Participants With One or More Adverse Events

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    End point title
    		 Percentage of Participants With One or More Adverse Events [1]
    End point description
    All treatment-emergent adverse events were recorded and summarized.
    End point type
    Primary
    End point timeframe
    Group 1: up to Week 16; Group 2: up to Week 20
    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 between-group statistical comparisons were planned for safety and tolerability endpoints.
    End point values
    		 Group 1: Low-dose Group Group 2: High-dose Group
    Number of subjects analysed
    17
    18
    Units: Percentage of participants
        number (not applicable)
    88.24
    100
    No statistical analyses for this end point

    Primary: Percentage of Participants With One or More Severe (≥Grade 3) Adverse Events

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    End point title
    		 Percentage of Participants With One or More Severe (≥Grade 3) Adverse Events [2]
    End point description
    All treatment-emergent adverse events with Common Terminology Criteria for Adverse Events (CTCAE) ≥Grade 3 (severe) were recorded and summarized.
    End point type
    Primary
    End point timeframe
    Group 1: up to Week 16; Group 2: up to Week 20
    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 between-group statistical comparisons were planned for safety and tolerability endpoints.
    End point values
    		 Group 1: Low-dose Group Group 2: High-dose Group
    Number of subjects analysed
    17
    18
    Units: Percentage of participants
        number (not applicable)
    17.65
    38.89
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Hypertension Who Experience Improvement in Blood Pressure Following Treatment With CORT125134

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    End point title
    		 Percentage of Participants With Hypertension Who Experience Improvement in Blood Pressure Following Treatment With CORT125134
    End point description
    Improvement in BP was defined as a participant who experiences at least a 5 mmHg decrease in mean diastolic or systolic BP from Baseline who has not taken an additional antihypertensive medication during the treatment period or increased the dosage of a concurrent antihypertensive medication. The population analyzed was all enrolled participants with hypertension at Baseline who received at least one dose of study drug and had at least one post-baseline assessment.
    End point type
    Secondary
    End point timeframe
    Group 1: Week 12 or last observation; Group 2: Week 16, or last observation
    End point values
    		 Group 1: Low-dose Group Group 2: High-dose Group
    Number of subjects analysed
    12
    11
    Units: Percentage of participants
        number (confidence interval 95%)
    41.67 (15.17 to 72.33)
    63.64 (30.79 to 89.07)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With IGT / T2DM Who Experienced a ≥25% Reduction in AUCglucose Following Treatment With CORT125134

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    End point title
    		 Percentage of Participants With IGT / T2DM Who Experienced a ≥25% Reduction in AUCglucose Following Treatment With CORT125134
    End point description
    Improvement in glucose control was defined as a participant who experiences at least a 25% decrease from baseline in area under the concentration-time curve for blood glucose (AUCglucose) who has not taken an additional diabetes medication during the treatment period or increased the dosage of a concurrent diabetes medication. The population analyzed was all enrolled participants with IGT / T2DM at Baseline who received at least one dose of study drug and had at least one post-baseline assessment.
    End point type
    Secondary
    End point timeframe
    Before and 0.5, 1, 1.5, and 2 hours after a glucose drink at Week 12 or last observation (Group 1) or Week 16 or last observation (Group 2)
    End point values
    		 Group 1: Low-dose Group Group 2: High-dose Group
    Number of subjects analysed
    13
    14
    Units: Percentage of participants
        number (confidence interval 95%)
    23.08 (5.04 to 53.81)
    0 (0 to 23.16)
    No statistical analyses for this end point

    Post-hoc: Percentage of Participants With IGT / T2DM Who Experience Improvement in Glucose Control Following Treatment With CORT125134: Responder Definition Based on Response Criteria for Phase 3 Study NCT03697109 (2018-003096-35)

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    End point title
    		 Percentage of Participants With IGT / T2DM Who Experience Improvement in Glucose Control Following Treatment With CORT125134: Responder Definition Based on Response Criteria for Phase 3 Study NCT03697109 (2018-003096-35)
    End point description
    Improvement in glucose control was defined as a participant who experiences 1) a hemoglobin A1c (HbA1c) that is decreased by ≥ 0.5% from baseline, 2) a 2-hour oGTT plasma glucose that is normalized (< 7.8 mmol/L) or decreased by ≥ 2.8 mmol/L from baseline, or 3) a total daily insulin dose that has decreased by ≥25% or total daily sulfonylurea dose that has decreased by ≥ 50% and an HbA1c that is unchanged or decreased from baseline. The population analyzed was all enrolled participants with IGT / T2DM at Baseline who received at least one dose of study drug and had non-missing post-baseline data collected, with exclusions based on clinical judgment and/or important protocol deviations applied on a visit and outcome level rather than a participant level.
    End point type
    Post-hoc
    End point timeframe
    Before and 0.5, 1, 1.5, and 2 hours after a glucose drink at Week 12 or last observation (Group 1) or Week 16 or last observation (Group 2)
    End point values
    		 Group 1: Low-dose Group Group 2: High-dose Group
    Number of subjects analysed
    13
    12
    Units: Percentage of participants
        number (confidence interval 95%)
    15.38 (1.92 to 45.45)
    50.00 (21.09 to 78.91)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Group 1: up to Week 16; Group 2: up to Week 20
    Adverse event reporting additional description
    All enrolled participants who received at least 1 dose of study drug
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Group 1: Low-dose Group
    Reporting group description
    		 100 mg/day for 4 weeks in Period 1, then 150 mg/day for 4 weeks in Period 2, then 200 mg/day for 4 weeks in Period 3. Period 3 was followed by a 4-week follow-up period.

    Reporting group title
    Group 2: High-dose Group
    Reporting group description
    		 250 mg/day for 4 weeks in Period 1, then 300 mg/day for 4 weeks in Period 2, then 350 mg/day for 4 weeks in Period 3, then 400 mg/day for 4 weeks in Period 4.

    Serious adverse events
    		 Group 1: Low-dose Group Group 2: High-dose Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 17 (0.00%)
    4 / 18 (22.22%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Polyneuropathy
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Myopathy
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pilonidal cyst
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Group 1: Low-dose Group Group 2: High-dose Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 17 (88.24%)
    18 / 18 (100.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    3 / 17 (17.65%)
    0 / 18 (0.00%)
         occurrences all number
    3
    0
    Contusion
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Haematoma
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Peripheral venous disease
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Phlebitis
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Surgical and medical procedures
    Medical device removal
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Oedema peripheral
         subjects affected / exposed
    4 / 17 (23.53%)
    5 / 18 (27.78%)
         occurrences all number
    6
    10
    Peripheral swelling
         subjects affected / exposed
    1 / 17 (5.88%)
    2 / 18 (11.11%)
         occurrences all number
    2
    2
    Asthenia
         subjects affected / exposed
    2 / 17 (11.76%)
    1 / 18 (5.56%)
         occurrences all number
    4
    2
    Fatigue
         subjects affected / exposed
    2 / 17 (11.76%)
    2 / 18 (11.11%)
         occurrences all number
    2
    2
    Adverse drug reaction
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Fat tissue increased
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Flushing
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 18 (5.56%)
         occurrences all number
    1
    1
    Influenza like illness
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Pain
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 18 (5.56%)
         occurrences all number
    1
    1
    Chest pain
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 18 (11.11%)
         occurrences all number
    0
    2
    Application site bruise
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    2
    Application site irritation
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Pyrexia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Dizziness
         subjects affected / exposed
    3 / 17 (17.65%)
    4 / 18 (22.22%)
         occurrences all number
    3
    5
    Bronchitis
         subjects affected / exposed
    1 / 17 (5.88%)
    2 / 18 (11.11%)
         occurrences all number
    1
    2
    Reproductive system and breast disorders
    Vaginal haemorrhage
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 18 (11.11%)
         occurrences all number
    0
    2
    Respiratory, thoracic and mediastinal disorders
    Wheezing
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Cough
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Pneumonia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Respiratory failure
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Drug withdrawal syndrome
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Emotional distress
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Sleep disorder
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Investigations
    Activated partial thromboplastin time prolonged
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    C-reactive protein increased
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 18 (11.11%)
         occurrences all number
    0
    2
    Body temperature increased
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    2
    Glucocorticoids abnormal
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Spinal fracture
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 17 (23.53%)
    5 / 18 (27.78%)
         occurrences all number
    5
    9
    Somnolence
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Neuropathy peripheral
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 18 (11.11%)
         occurrences all number
    0
    2
    Sciatica
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 18 (11.11%)
         occurrences all number
    0
    2
    Cervicobrachial syndrome
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    5
    Diabetic neuropathy
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Hypoaesthesia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Insomnia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Migraine
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    3
    Nerve root compression
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Nystagmus
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 17 (0.00%)
    3 / 18 (16.67%)
         occurrences all number
    0
    3
    Ear and labyrinth disorders
    Deafness
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Ear pain
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Vertigo
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 18 (11.11%)
         occurrences all number
    0
    2
    Eye disorders
    Astigmatism
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Cataract
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Conjunctival haemorrhage
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Photopsia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    0 / 17 (0.00%)
    3 / 18 (16.67%)
         occurrences all number
    0
    3
    Abdominal pain
         subjects affected / exposed
    0 / 17 (0.00%)
    4 / 18 (22.22%)
         occurrences all number
    0
    6
    Abdominal pain upper
         subjects affected / exposed
    1 / 17 (5.88%)
    2 / 18 (11.11%)
         occurrences all number
    1
    4
    Constipation
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 18 (5.56%)
         occurrences all number
    1
    1
    Diarrhoea
         subjects affected / exposed
    4 / 17 (23.53%)
    3 / 18 (16.67%)
         occurrences all number
    7
    7
    Dyspepsia
         subjects affected / exposed
    1 / 17 (5.88%)
    4 / 18 (22.22%)
         occurrences all number
    1
    5
    Nausea
         subjects affected / exposed
    3 / 17 (17.65%)
    5 / 18 (27.78%)
         occurrences all number
    5
    7
    Vomiting
         subjects affected / exposed
    2 / 17 (11.76%)
    1 / 18 (5.56%)
         occurrences all number
    2
    1
    Flatulence
         subjects affected / exposed
    1 / 17 (5.88%)
    2 / 18 (11.11%)
         occurrences all number
    1
    4
    Haemorrhoids
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Gingival hyperpigmentation
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    2 / 17 (11.76%)
    1 / 18 (5.56%)
         occurrences all number
    4
    3
    Dry skin
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Hyperhidrosis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Application site vesicles
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    2
    Dermatitis
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    2
    Erythema
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Folliculitis
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Hidradenitis
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Hyperkeratosis
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Night sweats
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Pigmentation disorder
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Pruritus
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Skin hyperpigmentation
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Polyuria
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Endocrine disorders
    Cushing's syndrome
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Diabetes mellitus inadequate control
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Hyperprolactinaemia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    4 / 17 (23.53%)
    7 / 18 (38.89%)
         occurrences all number
    11
    26
    Pain in extremity
         subjects affected / exposed
    4 / 17 (23.53%)
    4 / 18 (22.22%)
         occurrences all number
    10
    7
    Arthralgia
         subjects affected / exposed
    2 / 17 (11.76%)
    4 / 18 (22.22%)
         occurrences all number
    2
    10
    Joint swelling
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 18 (5.56%)
         occurrences all number
    1
    2
    Myalgia
         subjects affected / exposed
    1 / 17 (5.88%)
    4 / 18 (22.22%)
         occurrences all number
    1
    7
    Musculoskeletal pain
         subjects affected / exposed
    0 / 17 (0.00%)
    3 / 18 (16.67%)
         occurrences all number
    0
    8
    Intervertebral disc disorder
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Medial tibial stress syndrome
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Muscle fatigue
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    6
    Neck pain
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Pain in jaw
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Temporomandibular joint syndrome
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Muscular weakness
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Pilonidal cyst
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Infections and infestations
    Fungal infection
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Lymphangitis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 18 (5.56%)
         occurrences all number
    1
    1
    Candida infection
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Enterobacter infection
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Escherichia urinary tract infection
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Herpes zoster
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Sinusitis
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 18 (5.56%)
         occurrences all number
    1
    1
    Hypocalcaemia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Hypoglycaemia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Hypokalaemia
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 18 (5.56%)
         occurrences all number
    2
    1
    Increased appetite
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Hypothyroidism
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 May 2016
    Amendment 2 Version 4.0: 1) clarified details of urinary free cortisol and salivary cortisol sampling times; 2) clarified the timing of oGTTs and 24-hour ambulatory blood pressure monitoring; 3) changed dose levels; 4) added dose-escalation rule; 5) specified the timing of DRC review in the study design figure; 6) updated eligibility criteria; 7) clarified the number of capsules to use and capsule packaging; 8) detail added to the dose reduction and escalation options; 9) cautioned against foods known to inhibit CYP2C8 or CYP3A4; 10) added details and requirement for completion of Patient Diary Card; 11) defined the fasting time before oGTT test; 12) clarified timing of ambulatory blood pressure measurements; 13) specified time windows for PK samples; 14) clarified dose-escalation rule; 15) clarified visit windows; 16) clarified the screening tests to be performed if a washout period is needed for participants taking Cushing medications.
    16 Nov 2017
    Version 6.0: 1) added that participants who complete 12 weeks of dosing in Group 1, and on the recommendation of the Investigator and with agreement of the Medical Monitor may proceed into Group 2 and receive the Group 3 dose-escalation scheme; 2) made modifications and clarifications to the screening procedures and the inclusion and exclusion criteria; 3) made clarifications and updates to assessment procedures; 4) made clarifications to the Statistical Analysis Plan.
    15 Jan 2018
    Version 7.0: 1) the CORT125134 400 mg dose level was added to the Group 2 dose escalation scheme; 2) extended the age range from 75 to 80 years; 3) corrected the definition of impaired glucose tolerance; 4) clarified the assessments required for participants who proceed from Group 1 to Group 2 dose escalation.

    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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