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    Clinical Trial Results:
    A Randomised, Double-blind, Placebo-controlled Phase IIa Study to Assess the Pharmacodynamics, Safety, and Pharmacokinetics of AZD4901 When Given in Multiple Doses to Females with Polycystic Ovary Syndrome

    Summary
    EudraCT number
    2013-000788-98
    Trial protocol
    GB  
    Global end of trial date
    25 Jul 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    01 Feb 2017
    First version publication date
    07 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D5320C00001
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    AstraZeneca Pharmaceuticals LP
    Sponsor organisation address
    2 Kingdom Street, Paddington, London, United Kingdom, W6 6BD
    Public contact
    Martin L. Scott, MD/PhD, AstraZeneca Pharmaceuticals LP, 1 (781) 472-5130, martin.scott@astrazeneca.com
    Scientific contact
    Martin L. Scott, MD/PhD, AstraZeneca Pharmaceuticals LP, 1 (781) 472-5130, martin.scott@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
    14 May 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Jul 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to determine change-from-baseline of LH area under the concentration-time curve from time zero to 8 hours postdose [AUC(0-8)] at Day 7 in comparison to placebo.
    Protection of trial subjects
    The IDMC was charged with interpreting the results of an interim analysis
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    25 Jun 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 31
    Country: Number of subjects enrolled
    United Kingdom: 26
    Country: Number of subjects enrolled
    Germany: 8
    Worldwide total number of subjects
    65
    EEA total number of subjects
    34
    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)
    65
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Approximately 56 patients were to be enrolled (14 patients per treatment group) to ensure 12 evaluable patients in each of the 4 treatment groups.

    Pre-assignment
    Screening details
    Screening began up to 60 days prior to baseline visit allowing a washout period for patients taking OCP. Patients who had assessment more than 3 weeks prior to baseline returned to the site between Day -21 to -2 for repeat lab assessments. Patients not taking OCP who had had screening assessments within 3 weeks of baseline did not repeat lab tests

    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, Data analyst, Assessor
    Blinding implementation details
    Subjects were randomised 1:1:1:1 to one of three treatment levels or control

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Administered orally
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Two placebo tablets twice per day

    Arm title
    20 mg AZD4901 once daily
    Arm description
    20 mg AZD4901 once daily
    Arm type
    Experimental

    Investigational medicinal product name
    AZD4901
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One tablet + one placebo tablet once per day and two placebo tablets once per day

    Arm title
    20 mg AZD4901 twice daily
    Arm description
    20 mg AZD4901 twice daily
    Arm type
    Experimental

    Investigational medicinal product name
    AZD4901
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One tablet + one placebo tablet twice per day

    Arm title
    40 mg AZD4901 twice daily
    Arm description
    40 mg AZD4901 twice daily
    Arm type
    Experimental

    Investigational medicinal product name
    AZD4901
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Two tablets twice per day

    Number of subjects in period 1
    Placebo 20 mg AZD4901 once daily 20 mg AZD4901 twice daily 40 mg AZD4901 twice daily
    Started
    16
    15
    17
    17
    Completed
    16
    15
    14
    15
    Not completed
    0
    0
    3
    2
         Protocol deviation
    -
    -
    1
    -
         Adverse event, non-fatal
    -
    -
    1
    -
         Consent withdrawn by subject
    -
    -
    1
    -
         Patient met exclusion criterion 16.
    -
    -
    -
    1
         Dose administration non-compliance
    -
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Administered orally

    Reporting group title
    20 mg AZD4901 once daily
    Reporting group description
    20 mg AZD4901 once daily

    Reporting group title
    20 mg AZD4901 twice daily
    Reporting group description
    20 mg AZD4901 twice daily

    Reporting group title
    40 mg AZD4901 twice daily
    Reporting group description
    40 mg AZD4901 twice daily

    Reporting group values
    Placebo 20 mg AZD4901 once daily 20 mg AZD4901 twice daily 40 mg AZD4901 twice daily Total
    Number of subjects
    16 15 17 17 65
    Age categorical
    Units: Subjects
        In utero
    0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0 0
        Newborns (0-27 days)
    0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0 0 0
        Children (2-11 years)
    0 0 0 0 0
        Adolescents (12-17 years)
    0 0 0 0 0
        Adults (18-64 years)
    16 15 17 17 65
        From 65-84 years
    0 0 0 0 0
        85 years and over
    0 0 0 0 0
    Age Continuous |
    Units: years
        arithmetic mean (standard deviation)
    27 ± 3 29 ± 6 27 ± 6 28 ± 6 -
    Gender, Male/Female
    Units: Participants
        Female
    16 15 17 17 65
        Male
    0 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Administered orally

    Reporting group title
    20 mg AZD4901 once daily
    Reporting group description
    20 mg AZD4901 once daily

    Reporting group title
    20 mg AZD4901 twice daily
    Reporting group description
    20 mg AZD4901 twice daily

    Reporting group title
    40 mg AZD4901 twice daily
    Reporting group description
    40 mg AZD4901 twice daily

    Primary: LH AUC(0-8) comparisons of active treatment vs Placebo

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    End point title
    LH AUC(0-8) comparisons of active treatment vs Placebo [1]
    End point description
    End point type
    Primary
    End point timeframe
    Day 7
    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: There is no statistical analysis, because it wasn’t planned in the study.
    End point values
    Placebo 20 mg AZD4901 once daily 20 mg AZD4901 twice daily 40 mg AZD4901 twice daily
    Number of subjects analysed
    13
    13
    14
    15
    Units: AURatio (%)
    geometric mean (confidence interval 1%)
        Ratio (%) compared to placebo (Primary)
    100 (100 to 100)
    87.04 (58.52 to 129.47)
    78.76 (53.41 to 116.16)
    47.99 (32.73 to 70.36)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All SAEs recorded from the time of informed consent. Nonserious AEs collected beginning at the baseline visit throughout the treatment period and including the follow-up period.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    20 mg AZD4901 once daily
    Reporting group description
    -

    Reporting group title
    20 mg AZD4901 twice daily
    Reporting group description
    -

    Reporting group title
    40 mg AZD4901 twice daily
    Reporting group description
    -

    Reporting group title
    Placebo
    Reporting group description
    -

    Serious adverse events
    20 mg AZD4901 once daily 20 mg AZD4901 twice daily 40 mg AZD4901 twice daily Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 17 (5.88%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 17 (5.88%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    20 mg AZD4901 once daily 20 mg AZD4901 twice daily 40 mg AZD4901 twice daily Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 15 (40.00%)
    13 / 17 (76.47%)
    5 / 17 (29.41%)
    6 / 16 (37.50%)
    Vascular disorders
    Hot Flush
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 17 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    General disorders and administration site conditions
    Nodule
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 17 (5.88%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Influenza Like Illness
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 17 (0.00%)
    1 / 17 (5.88%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    0
    Pyrexia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 17 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Reproductive system and breast disorders
    Vaginal haemorrhage
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 17 (5.88%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    0
    2
    Pelvic Pain
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (0.00%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Vaginal Discharge
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 17 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    Injury, poisoning and procedural complications
    Procedural dizziness
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 17 (5.88%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Tooth fracture
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 17 (5.88%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Muscle Strain
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (0.00%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Investigations
    Hepatic Enzyme Increased
         subjects affected / exposed
    2 / 15 (13.33%)
    0 / 17 (0.00%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Alanine Aminotransferase Increased
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 17 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Aspartate Aminotransferase Increased
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 17 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Rhinitis allergic
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 17 (5.88%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Sleep apnoea syndrome
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 17 (5.88%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 15 (13.33%)
    3 / 17 (17.65%)
    4 / 17 (23.53%)
    5 / 16 (31.25%)
         occurrences all number
    4
    3
    4
    5
    Migraine
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 17 (5.88%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Presyncope
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 17 (5.88%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Syncope
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 17 (5.88%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Dizziness
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (0.00%)
    1 / 17 (5.88%)
    1 / 16 (6.25%)
         occurrences all number
    1
    0
    1
    1
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (0.00%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 17 (5.88%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 17 (5.88%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Abdominal pain lower
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 17 (5.88%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Abdominal pain
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 17 (5.88%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Abdominal pain upper
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 17 (5.88%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Nausea
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    3
    0
    0
    1
    Constipation
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (0.00%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Diarrhoea
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 17 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 17 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 17 (5.88%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Rash
         subjects affected / exposed
    0 / 15 (0.00%)
    2 / 17 (11.76%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Musculoskeletal and connective tissue disorders
    Muscle Spasms
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    2 / 15 (13.33%)
    1 / 17 (5.88%)
    1 / 17 (5.88%)
    1 / 16 (6.25%)
         occurrences all number
    2
    1
    1
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 17 (5.88%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Appendicitis
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 17 (5.88%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Vulvovaginal Mycotic Infection
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (0.00%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastrointestinal Infection
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 17 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    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
    31 May 2013
    The supply of the investigational product to the patients for the duration of the study was clarified in the study design. The 0 hour sampling time was clarified in the study design and table of study design. A new footnote was added to the study design table to include information on discontinuation based on suicidal ideation/behavior as seen in the C-SSRS. Exclusion criterion 27, concomitant medication and table on restricted medications were modified. New exclusion criterion was added and discontinuation of investigational product updated based on C SSRS. Study stopping criteria was modified. Storage period of PGx samples was modified.
    06 Jun 2013
    This amendment was applicable for study sites only in UK. HIV testing was removed at all occurrences in the CSP.
    18 Oct 2013
    The rescreening window was amended to Day - 21 to Day -2 and the relevant sections were updated in the CSP. Study restriction (restriction #3) was amended.
    20 Mar 2014
    List of abbreviations, clinical studies section, benefit/risk and ethical assessment, and restricted medication table in the CSP were updated.

    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
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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