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    Clinical Trial Results:
    A Proof of Concept Study to Determine the Minimum Effective Dose and to Assess the Efficacy and Safety of Subcutaneous Injections of FPFS-1169 in Parkinson's Disease Patients

    Summary
    EudraCT number
    		 2006-000361-11
    Trial protocol
    		 GB  
    Global end of trial date
    30 Mar 2007

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Jul 2022
    First version publication date
    21 Jul 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RD 639/24201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Fujimoto Pharmaceutical Corp
    Sponsor organisation address
    1-3-40 Nishiotsuka Matsubara, Osaka, Japan, 580-0011
    Public contact
    Dr Lan wuTann, Simbec-Orion Clinical Pharmacology, +44 1443690977, lan.tann@simbecorion.com
    Scientific contact
    Dr Lan wuTann, Simbec-Orion Clinical Pharmacology, +44 1443690977, lan.tann@simbecorion.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
    31 Jul 2007
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Mar 2007
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Mar 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the trial was: - To determine the minimum effective dose (MED) and corresponding plasma concentrations of subcutaneous injections of FPFS-1169 in Parkinson’s disease patients. The secondary objectives of the trial were: - To evaluate the acute effects of subcutaneous injection of FPFS-1169 on the severity of parkinsonian signs in patients with mild to moderately advanced Parkinson’s disease. - To monitor subject safety by means of frequent clinical evaluations and laboratory tests.
    Protection of trial subjects
    The study was conducted in accordance with the Declaration of Helsinki (South Africa 1996) and the ABPI Guidelines for Medical Experiments on Non-Patient Human Volunteers - 1988, amended May 1990.), the Guidelines of the International Conference on Harmonisation (ICH) on Good Clinical Practice (GCP) (CPMP/ICH/135/95), as well as the requirements of the European Union Data Protection Directive 95/46/EC, and other applicable regulatory requirements.
    Background therapy
    		 As part of the study, all patients received a standard dose of levodopa/carbidopa on study Day 1 (study period 1).
    Evidence for comparator
    		 N/A - no comparator products were evaluated in this study.
    Actual start date of recruitment
    21 Sep 2006
    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 Kingdom: 10
    Worldwide total number of subjects
    10
    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)
    4
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study recruitment was undertaken in the United Kingdom. The recruitment process began in September 2006 and concluded in February 2007 with 18 patients screening in order to enrol 10 eligible patients.

    Pre-assignment
    Screening details
    		 Patients were screened to the inclusion/exclusion criteria of the protocol. The following assessments were performed: Informed consent, Medical History including current conditions, Physical Exam, Demographics, Height, Weight & BMI, ECG, Vital Signs, Safety Laboratory Testing/Urinalysis & other specific testing related to Parkinson's Disease.

    Period 1
    Period 1 title
    Overall Trial Period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    N/A - the study was open label.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Arm 1 - 3 mg FPFS-1169
    Arm description
    		 This was the lowest dose level evaluated in the study. 2 participants were administered 3.0 mg of FPFS-1169 as a subcutaneous injection.
    Arm type
    		 Experimental

    Investigational medicinal product name
    FPFS-1169
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Dosing frequency was one occasion across 5 study periods (Day 1, Day 8, Day 15, Day 22 & Day 29). Dose levels were adjusted per study period based on assessment of previous dose level administered.

    Arm title
    		 Arm 2 - 4.5 mg FPFS-1169
    Arm description
    		 This was the second dose level evaluated in the study. 2 participants were administered 4.5 mg of FPFS-1169 as a subcutaneous injection.
    Arm type
    		 Experimental

    Investigational medicinal product name
    FPFS-1169
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Dosing frequency was one occasion across 5 study periods (Day 1, Day 8, Day 15, Day 22 & Day 29). Dose levels were adjusted per study period based on assessment of previous dose level administered.

    Arm title
    		 Arm 3 - 6.0 mg FPFS-1169
    Arm description
    		 This was the third dose level evaluated in the study. 5 participants were administered 6.0 mg of FPFS-1169 as a subcutaneous injection.
    Arm type
    		 Experimental

    Investigational medicinal product name
    FPFS-1169
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Dosing frequency was one occasion across 5 study periods (Day 1, Day 8, Day 15, Day 22 & Day 29). Dose levels were adjusted per study period based on assessment of previous dose level administered.

    Arm title
    		 Arm 4 - 7.5 mg FPFS-1169
    Arm description
    		 This was the fourth dose level evaluated in the study. 2 participants were administered 7.5 mg of FPFS-1169 as a subcutaneous injection.
    Arm type
    		 Experimental

    Investigational medicinal product name
    FPFS-1169
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Dosing frequency was one occasion across 5 study periods (Day 1, Day 8, Day 15, Day 22 & Day 29). Dose levels were adjusted per study period based on assessment of previous dose level administered.

    Arm title
    		 Arm 5 - 9.0 mg FPFS-1169
    Arm description
    		 This was the fifth dose level evaluated in the study. 3 participants were administered 9.0 mg of FPFS-1169 as a subcutaneous injection.
    Arm type
    		 Experimental

    Investigational medicinal product name
    FPFS-1169
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Dosing frequency was one occasion across 5 study periods (Day 1, Day 8, Day 15, Day 22 & Day 29). Dose levels were adjusted per study period based on assessment of previous dose level administered.

    Arm title
    		 Arm 6 - 12.0 mg FPFS-1169
    Arm description
    		 This was the sixth dose level evaluated in the study. 8 participants were administered 12.0 mg of FPFS-1169 as a subcutaneous injection.
    Arm type
    		 Experimental

    Investigational medicinal product name
    FPFS-1169
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Dosing frequency was one occasion across 5 study periods (Day 1, Day 8, Day 15, Day 22 & Day 29). Dose levels were adjusted per study period based on assessment of previous dose level administered.

    Arm title
    		 Arm 7- 15.0 mg FPFS-1169
    Arm description
    		 This was the seventh dose level evaluated in the study. 2 participants were administered 15.0 mg of FPFS-1169 as a subcutaneous injection.
    Arm type
    		 Experimental

    Investigational medicinal product name
    FPFS-1169
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Dosing frequency was one occasion across 5 study periods (Day 1, Day 8, Day 15, Day 22 & Day 29). Dose levels were adjusted per study period based on assessment of previous dose level administered.

    Arm title
    		 Arm 8 - 18.0 mg FPFS-1169
    Arm description
    		 This was the eighth dose level evaluated in the study. 3 participants were administered 18.0 mg of FPFS-1169 as a subcutaneous injection.
    Arm type
    		 Experimental

    Investigational medicinal product name
    FPFS-1169
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Dosing frequency was one occasion across 5 study periods (Day 1, Day 8, Day 15, Day 22 & Day 29). Dose levels were adjusted per study period based on assessment of previous dose level administered.

    Arm title
    		 Arm 9 - 21.0 mg FPFS-1169
    Arm description
    		 This was the ninth dose level evaluated in the study. 1 participant was administered 21.0 mg of FPFS-1169 as a subcutaneous injection.
    Arm type
    		 Experimental

    Investigational medicinal product name
    FPFS-1169
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Dosing frequency was one occasion across 5 study periods (Day 1, Day 8, Day 15, Day 22 & Day 29). Dose levels were adjusted per study period based on assessment of previous dose level administered.

    Arm title
    		 Arm 10 - 24.0 mg FPFS-1169
    Arm description
    		 This was the highest dose level evaluated in the study. 1 participant was administered 24.0 mg of FPFS-1169 as a subcutaneous injection.
    Arm type
    		 Experimental

    Investigational medicinal product name
    FPFS-1169
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Dosing frequency was one occasion across 5 study periods (Day 1, Day 8, Day 15, Day 22 & Day 29). Dose levels were adjusted per study period based on assessment of previous dose level administered.

    Number of subjects in period 1
    		Arm 1 - 3 mg FPFS-1169 Arm 2 - 4.5 mg FPFS-1169 Arm 3 - 6.0 mg FPFS-1169 Arm 4 - 7.5 mg FPFS-1169 Arm 5 - 9.0 mg FPFS-1169 Arm 6 - 12.0 mg FPFS-1169 Arm 7- 15.0 mg FPFS-1169 Arm 8 - 18.0 mg FPFS-1169 Arm 9 - 21.0 mg FPFS-1169 Arm 10 - 24.0 mg FPFS-1169
    Started
    2
    2
    5
    2
    3
    8
    2
    3
    1
    1
    Completed
    2
    2
    5
    2
    3
    8
    2
    3
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial Period
    Reporting group description
    		 -

    Reporting group values
    		 Overall Trial Period Total
    Number of subjects
    		 10 10
    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)
    		 4 4
        From 65-84 years
    		 6 6
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 65.9 ± 7.9 -
    Gender categorical
    Units: Subjects
        Female
    		 1 1
        Male
    		 9 9
    Height
    Units: metre
        arithmetic mean (standard deviation)
    		 1.74 ± 0.06 -
    Weight
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    		 80.6 ± 10.5 -
    Body Mass Index (BMI)
    Units: kilogram(s)/square metre
        arithmetic mean (standard deviation)
    		 26.7 ± 2.8 -

    End points

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    End points reporting groups
    Reporting group title
    Arm 1 - 3 mg FPFS-1169
    Reporting group description
    		 This was the lowest dose level evaluated in the study. 2 participants were administered 3.0 mg of FPFS-1169 as a subcutaneous injection.

    Reporting group title
    Arm 2 - 4.5 mg FPFS-1169
    Reporting group description
    		 This was the second dose level evaluated in the study. 2 participants were administered 4.5 mg of FPFS-1169 as a subcutaneous injection.

    Reporting group title
    Arm 3 - 6.0 mg FPFS-1169
    Reporting group description
    		 This was the third dose level evaluated in the study. 5 participants were administered 6.0 mg of FPFS-1169 as a subcutaneous injection.

    Reporting group title
    Arm 4 - 7.5 mg FPFS-1169
    Reporting group description
    		 This was the fourth dose level evaluated in the study. 2 participants were administered 7.5 mg of FPFS-1169 as a subcutaneous injection.

    Reporting group title
    Arm 5 - 9.0 mg FPFS-1169
    Reporting group description
    		 This was the fifth dose level evaluated in the study. 3 participants were administered 9.0 mg of FPFS-1169 as a subcutaneous injection.

    Reporting group title
    Arm 6 - 12.0 mg FPFS-1169
    Reporting group description
    		 This was the sixth dose level evaluated in the study. 8 participants were administered 12.0 mg of FPFS-1169 as a subcutaneous injection.

    Reporting group title
    Arm 7- 15.0 mg FPFS-1169
    Reporting group description
    		 This was the seventh dose level evaluated in the study. 2 participants were administered 15.0 mg of FPFS-1169 as a subcutaneous injection.

    Reporting group title
    Arm 8 - 18.0 mg FPFS-1169
    Reporting group description
    		 This was the eighth dose level evaluated in the study. 3 participants were administered 18.0 mg of FPFS-1169 as a subcutaneous injection.

    Reporting group title
    Arm 9 - 21.0 mg FPFS-1169
    Reporting group description
    		 This was the ninth dose level evaluated in the study. 1 participant was administered 21.0 mg of FPFS-1169 as a subcutaneous injection.

    Reporting group title
    Arm 10 - 24.0 mg FPFS-1169
    Reporting group description
    		 This was the highest dose level evaluated in the study. 1 participant was administered 24.0 mg of FPFS-1169 as a subcutaneous injection.

    Subject analysis set title
    Subject 001 MED
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    This subject analysis set corresponds to the individual subject analysis for assessment of minimum effective dose (MED).

    Subject analysis set title
    Subject 002 MED
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    This subject analysis set corresponds to the individual subject analysis for assessment of minimum effective dose (MED).

    Subject analysis set title
    Subject 003 MED
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    This subject analysis set corresponds to the individual subject analysis for assessment of minimum effective dose (MED).

    Subject analysis set title
    Subject 006 MED
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    This subject analysis set corresponds to the individual subject analysis for assessment of minimum effective dose (MED).

    Subject analysis set title
    Subject 007 MED
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    This subject analysis set corresponds to the individual subject analysis for assessment of minimum effective dose (MED).

    Subject analysis set title
    Subject 008 MED
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    This subject analysis set corresponds to the individual subject analysis for assessment of minimum effective dose (MED).

    Subject analysis set title
    Subject 009 MED
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    This subject analysis set corresponds to the individual subject analysis for assessment of minimum effective dose (MED).

    Subject analysis set title
    Subject 010 MED
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    This subject analysis set corresponds to the individual subject analysis for assessment of minimum effective dose (MED).

    Primary: Maximum Concentration (Cmax)

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    End point title
    		 Maximum Concentration (Cmax) [1]
    End point description
    End point type
    Primary
    End point timeframe
    Time points for pharmacokinetic evaluation of Cmax in plasma were as follows: pre-dose, 0.5, 1, 2, 4 and 6 hours post dose on Days 8, 15, 22 & 29.
    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: Maximum Concentration (Cmax) were listed as descriptive statistics with no statistical analyses conducted.
    End point values
    		 Arm 1 - 3 mg FPFS-1169 Arm 2 - 4.5 mg FPFS-1169 Arm 3 - 6.0 mg FPFS-1169 Arm 4 - 7.5 mg FPFS-1169 Arm 5 - 9.0 mg FPFS-1169 Arm 6 - 12.0 mg FPFS-1169 Arm 7- 15.0 mg FPFS-1169 Arm 8 - 18.0 mg FPFS-1169 Arm 9 - 21.0 mg FPFS-1169 Arm 10 - 24.0 mg FPFS-1169
    Number of subjects analysed
    2
    2
    5
    2
    3
    8
    2
    3
    1
    1
    Units: ng/mL
        arithmetic mean (full range (min-max))
    1.937 (1.139 to 2.734)
    2.080 (1.435 to 2.725)
    3.934 (2.329 to 6.594)
    3.901 (2.800 to 5.002)
    6.270 (2.784 to 9.483)
    9.213 (4.221 to 15.882)
    6.206 (5.580 to 6.831)
    7.849 (6.056 to 10.499)
    16.653 (16.653 to 16.653)
    22.846 (22.846 to 22.846)
    No statistical analyses for this end point

    Primary: Time to maximum observed concentration (Tmax)

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    End point title
    		 Time to maximum observed concentration (Tmax) [2]
    End point description
    End point type
    Primary
    End point timeframe
    Time points for pharmacokinetic evaluation of Tmax in plasma were as follows: pre-dose, 0.5, 1, 2, 4 and 6 hours post dose on Days 8, 15, 22 & 29.
    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: Time to maximum observed concentration (Tmax) were listed as descriptive statistics with no statistical analyses conducted.
    End point values
    		 Arm 1 - 3 mg FPFS-1169 Arm 2 - 4.5 mg FPFS-1169 Arm 3 - 6.0 mg FPFS-1169 Arm 4 - 7.5 mg FPFS-1169 Arm 5 - 9.0 mg FPFS-1169 Arm 6 - 12.0 mg FPFS-1169 Arm 7- 15.0 mg FPFS-1169 Arm 8 - 18.0 mg FPFS-1169 Arm 9 - 21.0 mg FPFS-1169 Arm 10 - 24.0 mg FPFS-1169
    Number of subjects analysed
    2
    2
    5
    2
    3
    8
    2
    3
    1
    1
    Units: hour
        median (full range (min-max))
    0.50 (0.50 to 0.50)
    0.75 (0.50 to 1.00)
    0.50 (0.50 to 1.00)
    1.25 (0.50 to 2.00)
    0.50 (0.50 to 2.00)
    0.50 (0.50 to 1.00)
    0.75 (0.50 to 1.00)
    2.00 (0.50 to 4.00)
    1.00 (1.00 to 1.00)
    0.50 (0.50 to 0.50)
    No statistical analyses for this end point

    Primary: Area under the curve from the time of dosing to the time of the last measurable concentration (AUC0-t)

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    End point title
    		 Area under the curve from the time of dosing to the time of the last measurable concentration (AUC0-t) [3]
    End point description
    End point type
    Primary
    End point timeframe
    Time points for pharmacokinetic evaluation of AUC0-t in plasma were as follows: pre-dose, 0.5, 1, 2, 4 and 6 hours post dose on Days 8, 15, 22 & 29.
    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: Area under the curve from the time of dosing to the time of the last measurable concentration (AUC0-t) were listed as descriptive statistics with no statistical analyses conducted.
    End point values
    		 Arm 1 - 3 mg FPFS-1169 Arm 2 - 4.5 mg FPFS-1169 Arm 3 - 6.0 mg FPFS-1169 Arm 4 - 7.5 mg FPFS-1169 Arm 5 - 9.0 mg FPFS-1169 Arm 6 - 12.0 mg FPFS-1169 Arm 7- 15.0 mg FPFS-1169 Arm 8 - 18.0 mg FPFS-1169 Arm 9 - 21.0 mg FPFS-1169 Arm 10 - 24.0 mg FPFS-1169
    Number of subjects analysed
    2
    2
    5
    2
    3
    8
    2
    3
    1
    1
    Units: ng/ml/h
        arithmetic mean (full range (min-max))
    5.872 (4.422 to 7.321)
    6.342 (5.512 to 7.172)
    14.003 (7.549 to 21.016)
    16.403 (13.724 to 19.083)
    22.615 (14.260 to 37.500)
    25.392 (14.085 to 33.734)
    30.872 (28.936 to 32.808)
    36.320 (28.768 to 47.607)
    70.610 (70.610 to 70.610)
    73.802 (73.802 to 73.802)
    No statistical analyses for this end point

    Primary: Minimum Effective Dose

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    End point title
    		 Minimum Effective Dose [4]
    End point description
    End point type
    Primary
    End point timeframe
    Assessment of Minimum Effective Dose was carried out from Day 1 through to Day 29.
    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: Minimum Effective Dose were listed as descriptive statistics with no statistical analyses conducted.
    End point values
    		 Subject 001 MED Subject 002 MED Subject 003 MED Subject 006 MED Subject 007 MED Subject 008 MED Subject 009 MED Subject 010 MED
    Number of subjects analysed
    1
    1
    1
    1
    1
    1
    1
    1
    Units: milligram(s)
        number (not applicable)
    12
    6
    7.5
    15
    18
    24
    4.5
    9
    No statistical analyses for this end point

    Primary: Maximum Concentration (Cmax) - Minimum Effective Dose

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    End point title
    		 Maximum Concentration (Cmax) - Minimum Effective Dose [5]
    End point description
    End point type
    Primary
    End point timeframe
    Time points for pharmacokinetic evaluation of Cmax in plasma were as follows: pre-dose, 0.5, 1, 2, 4 and 6 hours post dose on Days 8, 15, 22 & 29.
    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: Maximum Concentration (Cmax) - Minimum Effective Dose were listed as descriptive statistics with no statistical analyses conducted.
    End point values
    		 Subject 001 MED Subject 002 MED Subject 003 MED Subject 006 MED Subject 007 MED Subject 008 MED Subject 009 MED Subject 010 MED
    Number of subjects analysed
    1
    1
    1
    1
    1
    1
    1
    1
    Units: ng/mL
        number (not applicable)
    12.836
    5.827
    5.002
    5.580
    6.056
    22.846
    1.435
    2.784
    No statistical analyses for this end point

    Primary: Area under the curve from the time of dosing to the time of the last measurable concentration (AUC0-t) - Minimum Effective Dose

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    End point title
    		 Area under the curve from the time of dosing to the time of the last measurable concentration (AUC0-t) - Minimum Effective Dose [6]
    End point description
    End point type
    Primary
    End point timeframe
    Time points for pharmacokinetic evaluation of AUC0-t in plasma were as follows: pre-dose, 0.5, 1, 2, 4 and 6 hours post dose on Days 8, 15, 22 & 29.
    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: Area under the curve from the time of dosing to the time of the last measurable concentration (AUC0-t) - Minimum Effective Dose were listed as descriptive statistics with no statistical analyses conducted.
    End point values
    		 Subject 001 MED Subject 002 MED Subject 003 MED Subject 006 MED Subject 007 MED Subject 008 MED Subject 009 MED Subject 010 MED
    Number of subjects analysed
    1
    1
    1
    1
    1
    1
    1
    1
    Units: ng/mL/h
        number (not applicable)
    33.734
    18.030
    19.083
    28.936
    32.586
    73.802
    5.512
    14.260
    No statistical analyses for this end point

    Secondary: Maximum Mean Change from Baseline (UPDRS Part III) - Minimum Effective Dose

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    End point title
    		 Maximum Mean Change from Baseline (UPDRS Part III) - Minimum Effective Dose
    End point description
    End point type
    Secondary
    End point timeframe
    Evaluation of UPDRS and changes from baseline were assessed at set timepoints from Day 1 through to the end of study.
    End point values
    		 Subject 001 MED Subject 002 MED Subject 003 MED Subject 006 MED Subject 007 MED Subject 008 MED Subject 009 MED Subject 010 MED
    Number of subjects analysed
    1
    1
    1
    1
    1
    1
    1
    1
    Units: UPDRS Score
        number (not applicable)
    -8.0
    -3.0
    -2.0
    -4.0
    -8.0
    -2.0
    -6.0
    -7.0
    No statistical analyses for this end point

    Secondary: Maximum Improvement in Timed Walk Test

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    End point title
    		 Maximum Improvement in Timed Walk Test
    End point description
    End point type
    Secondary
    End point timeframe
    Evaluation of improvement in timed walk test were assessed at set timepoints from Day 1 through to the end of study.
    End point values
    		 Arm 1 - 3 mg FPFS-1169 Arm 2 - 4.5 mg FPFS-1169 Arm 3 - 6.0 mg FPFS-1169 Arm 4 - 7.5 mg FPFS-1169 Arm 5 - 9.0 mg FPFS-1169 Arm 6 - 12.0 mg FPFS-1169 Arm 7- 15.0 mg FPFS-1169 Arm 8 - 18.0 mg FPFS-1169 Arm 9 - 21.0 mg FPFS-1169 Arm 10 - 24.0 mg FPFS-1169
    Number of subjects analysed
    2
    2
    5
    2
    3
    8
    2
    3
    1
    1
    Units: second
        number (not applicable)
    0.1
    0.7
    0.6
    1.4
    1.4
    0.88
    0.65
    0.47
    0.2
    0.7
    No statistical analyses for this end point

    Secondary: Time of Maximum Improvement - Timed Walk Test

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    End point title
    		 Time of Maximum Improvement - Timed Walk Test
    End point description
    End point type
    Secondary
    End point timeframe
    Evaluation of improvement in timed walk test were assessed at set timepoints from Day 1 through to the end of study.
    End point values
    		 Arm 1 - 3 mg FPFS-1169 Arm 2 - 4.5 mg FPFS-1169 Arm 3 - 6.0 mg FPFS-1169 Arm 4 - 7.5 mg FPFS-1169 Arm 5 - 9.0 mg FPFS-1169 Arm 6 - 12.0 mg FPFS-1169 Arm 7- 15.0 mg FPFS-1169 Arm 8 - 18.0 mg FPFS-1169 Arm 9 - 21.0 mg FPFS-1169 Arm 10 - 24.0 mg FPFS-1169
    Number of subjects analysed
    2
    2
    5
    2
    3
    8
    2
    3
    1
    1
    Units: hour
        number (not applicable)
    6.0
    0.5
    6.0
    6.0
    1.0
    5.0
    2.0
    3.0
    0.5
    0.5
    No statistical analyses for this end point

    Secondary: Treatment Emergent Adverse Events

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    End point title
    		 Treatment Emergent Adverse Events
    End point description
    This endpoint relates to the number of patients who reported a treatment emergent adverse event (TEAEs) during the study. There were a total of 18 treatment emergent adverse events reported during the study. Of these, 16 were reported following administration of subcutaneous injections of FPFS-1169. Two adverse events were reported following the standard dose of levodopa/carbidopa on Study Day 1. One of the treatment emergent adverse events was considered to be moderate in severity. All other events were considered to be mild in severity.
    End point type
    Secondary
    End point timeframe
    Collection of treatment emergent adverse events occurred from the point of dose administration until completion of the end of study.
    End point values
    		 Arm 1 - 3 mg FPFS-1169 Arm 2 - 4.5 mg FPFS-1169 Arm 3 - 6.0 mg FPFS-1169 Arm 4 - 7.5 mg FPFS-1169 Arm 5 - 9.0 mg FPFS-1169 Arm 6 - 12.0 mg FPFS-1169 Arm 7- 15.0 mg FPFS-1169 Arm 8 - 18.0 mg FPFS-1169 Arm 9 - 21.0 mg FPFS-1169 Arm 10 - 24.0 mg FPFS-1169
    Number of subjects analysed
    2
    2
    5
    2
    3
    8
    2
    3
    1
    1
    Units: Number of Subjects
    1
    0
    2
    0
    1
    4
    0
    1
    1
    0
    No statistical analyses for this end point

    Secondary: Laboratory Parameters

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    End point title
    		 Laboratory Parameters
    End point description
    This primary endpoint will report the number of subjects who had out of range results for any of the Laboratory Parameters (biochemistry, haematology & urinalysis). This endpoint will only report number of subjects who had out of range results from Day 1 onwards following administration of the IMP until the completion of the post study visit. There were no clinically significant biochemistry, haematology or urinalysis results during the study.
    End point type
    Secondary
    End point timeframe
    Laboratory Parameters (biochemistry, haematology and urinalysis) were measured at set time points from Day 1 until the end of the study.
    End point values
    		 Arm 1 - 3 mg FPFS-1169 Arm 2 - 4.5 mg FPFS-1169 Arm 3 - 6.0 mg FPFS-1169 Arm 4 - 7.5 mg FPFS-1169 Arm 5 - 9.0 mg FPFS-1169 Arm 6 - 12.0 mg FPFS-1169 Arm 7- 15.0 mg FPFS-1169 Arm 8 - 18.0 mg FPFS-1169 Arm 9 - 21.0 mg FPFS-1169 Arm 10 - 24.0 mg FPFS-1169
    Number of subjects analysed
    2
    2
    5
    2
    3
    8
    2
    3
    1
    1
    Units: Number of Subjects
    2
    2
    5
    2
    3
    8
    2
    3
    1
    1
    No statistical analyses for this end point

    Secondary: Vital Signs Parameters

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    End point title
    		 Vital Signs Parameters
    End point description
    This primary endpoint will report the number of subjects who had out of range results for any of the Vital Sign Parameters (systolic and diastolic blood pressure, pulse, oral temperature & respiration rate). This endpoint will only report number of subjects who had out of range results from Day 1 onwards following administration of the IMP until the completion of the post study visit. There were no clinically significant changes in vital signs parameters during the study at any dose level evaluated.
    End point type
    Secondary
    End point timeframe
    Vital Sign Parameters (systolic and diastolic blood pressure, pulse, respiration rate & oral temperature) were measured at set time points from Day 1 until the end of the study.
    End point values
    		 Arm 1 - 3 mg FPFS-1169 Arm 2 - 4.5 mg FPFS-1169 Arm 3 - 6.0 mg FPFS-1169 Arm 4 - 7.5 mg FPFS-1169 Arm 5 - 9.0 mg FPFS-1169 Arm 6 - 12.0 mg FPFS-1169 Arm 7- 15.0 mg FPFS-1169 Arm 8 - 18.0 mg FPFS-1169 Arm 9 - 21.0 mg FPFS-1169 Arm 10 - 24.0 mg FPFS-1169
    Number of subjects analysed
    2
    2
    5
    2
    3
    8
    2
    3
    1
    1
    Units: Number of Subjects
    2
    2
    5
    2
    3
    8
    2
    3
    1
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were reported from the time of signing informed consent until completion of the end of the study.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    8.0
    Reporting groups
    Reporting group title
    Arm 1 - 3 mg FPFS-1169
    Reporting group description
    		 This was the lowest dose level evaluated in the study. 2 participants were administered 3.0 mg of FPFS-1169 as a subcutaneous injection.

    Reporting group title
    Arm 2 - 4.5 mg FPFS-1169
    Reporting group description
    		 This was the second dose level evaluated in the study. 2 participants were administered 4.5 mg of FPFS-1169 as a subcutaneous injection.

    Reporting group title
    Arm 3 - 6.0 mg FPFS-1169
    Reporting group description
    		 This was the third dose level evaluated in the study. 5 participants were administered 6.0 mg of FPFS-1169 as a subcutaneous injection.

    Reporting group title
    Arm 4 - 7.5 mg FPFS-1169
    Reporting group description
    		 This was the fourth dose level evaluated in the study. 2 participants were administered 7.5 mg of FPFS-1169 as a subcutaneous injection.

    Reporting group title
    Arm 5 - 9.0 mg FPFS-1169
    Reporting group description
    		 This was the fifth dose level evaluated in the study. 3 participants were administered 9.0 mg of FPFS-1169 as a subcutaneous injection.

    Reporting group title
    Arm 6 - 12.0 mg FPFS-1169
    Reporting group description
    		 This was the sixth dose level evaluated in the study. 8 participants were administered 12.0 mg of FPFS-1169 as a subcutaneous injection.

    Reporting group title
    Arm 7- 15.0 mg FPFS-1169
    Reporting group description
    		 This was the seventh dose level evaluated in the study. 2 participants were administered 15.0 mg of FPFS-1169 as a subcutaneous injection.

    Reporting group title
    Arm 8 - 18.0 mg FPFS-1169
    Reporting group description
    		 This was the eighth dose level evaluated in the study. 3 participants were administered 18.0 mg of FPFS-1169 as a subcutaneous injection.

    Reporting group title
    Arm 9 - 21.0 mg FPFS-1169
    Reporting group description
    		 This was the ninth dose level evaluated in the study. 1 participant was administered 21.0 mg of FPFS-1169 as a subcutaneous injection.

    Reporting group title
    Arm 10 - 24.0 mg FPFS-1169
    Reporting group description
    		 This was the highest dose level evaluated in the study. 1 participant was administered 24.0 mg of FPFS-1169 as a subcutaneous injection.

    Reporting group title
    Baseline Dosing - Levodopa/Carbadopa
    Reporting group description
    		 This reporting group corresponds to all patients who reported an adverse event following administration of the standard Levodopa/Carbadopa dose on Day 1 of the study prior to FPFS-1169 administration.

    Serious adverse events
    		 Arm 1 - 3 mg FPFS-1169 Arm 2 - 4.5 mg FPFS-1169 Arm 3 - 6.0 mg FPFS-1169 Arm 4 - 7.5 mg FPFS-1169 Arm 5 - 9.0 mg FPFS-1169 Arm 6 - 12.0 mg FPFS-1169 Arm 7- 15.0 mg FPFS-1169 Arm 8 - 18.0 mg FPFS-1169 Arm 9 - 21.0 mg FPFS-1169 Arm 10 - 24.0 mg FPFS-1169 Baseline Dosing - Levodopa/Carbadopa
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Arm 1 - 3 mg FPFS-1169 Arm 2 - 4.5 mg FPFS-1169 Arm 3 - 6.0 mg FPFS-1169 Arm 4 - 7.5 mg FPFS-1169 Arm 5 - 9.0 mg FPFS-1169 Arm 6 - 12.0 mg FPFS-1169 Arm 7- 15.0 mg FPFS-1169 Arm 8 - 18.0 mg FPFS-1169 Arm 9 - 21.0 mg FPFS-1169 Arm 10 - 24.0 mg FPFS-1169 Baseline Dosing - Levodopa/Carbadopa
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 2 (0.00%)
    2 / 5 (40.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    4 / 8 (50.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    1 / 1 (100.00%)
    0 / 1 (0.00%)
    2 / 10 (20.00%)
    Investigations
    Blood glucose abnormal
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    Blood urea increased
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Blood creatine increased
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    1 / 5 (20.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    2 / 8 (25.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    2
    0
    0
    0
    0
    0
    Parosmia
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    General disorders and administration site conditions
    Feeling abnormal
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 2 (0.00%)
    1 / 5 (20.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 1 (100.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 1 (100.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Groin pain
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Metabolism and nutrition disorders
    Increased appetite
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 May 2006
    Protocol Amendment No. 1 (dated 25 May 2006) was generated to document the change to the Research Site used for the study. This was due to the superior facilities available at the purpose built Clinical Research Facility. This amendment also documented additions to the list of co-investigators, inclusion of a follow-up telephone call for the purposes of monitoring the safety and well-being of the subjects, removal of pharmacokinetic samples and local tolerability assessments on Study Day 1 (standard levodopa/carbidopa dose) & correction of other minor typographical errors.
    28 Feb 2007
    Protocol Amendment No. 2 (dated 28 Feb 2007) documented the addition of a further Investigator.

    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.
    N/A
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