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    Clinical Trial Results:
    An Open-label, Randomized, Single-dose, 2-Period, 2-Treatment Crossover Study to Assess the Bioequivalence of Cinacalcet Capsule (Administered as Six of the 5-mg Cinacalcet Capsules) With 30-mg Commercial Cinacalcet Tablet in Healthy Adult Volunteers

    Summary
    EudraCT number
    		 2017-002659-28
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    28 Dec 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Dec 2017
    First version publication date
    30 Dec 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    20160428
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Amgen
    Sponsor organisation address
    One Amgen Center Drive, Thousand Oaks, CA, United States, 91320
    Public contact
    IHQ Medical Info-Clinical Trials, Amgen (EUROPE) GmbH, MedInfoInternational@amgen.com
    Scientific contact
    IHQ Medical Info-Clinical Trials, Amgen (EUROPE) GmbH, MedInfoInternational@amgen.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000078-PIP01-07
    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
    28 Dec 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Dec 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate the bioequivalence, based on the area under the plasma drug concentration-time curve from time zero to infinity (AUCinf), area under the plasma drug concentration-time curve from time zero to a specific time point (AUC0-t), and the maximum observed concentration (Cmax), between the contents of six of the 5-mg cinacalcet capsules sprinkled over applesauce and a single 30-mg commercial formulation tablet of cinacalcet with applesauce in healthy adult volunteers.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) and applicable national and regional regulations/guidelines. The protocol, proposed informed consent form, other written subject information, and any proposed advertising material were reviewed and approved by an institutional review board (IRB) before recruitment of subjects into the study and shipment of Amgen investigational product to the study site. The investigator obtained written informed consent from the subject or legally acceptable representative after adequate explanation of the aims, methods, anticipated benefits, and potential hazards of the study and before any protocol-specific screening procedures or any investigational product was administered.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Dec 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 44
    Worldwide total number of subjects
    44
    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)
    44
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted at a single site in the United States.

    Pre-assignment
    Screening details
    		 Healthy men and women who were 18 to 65 years of age (inclusive) at the time of randomization were eligible for participation in this study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Cinacalcet
    Arm description
    		 Participants received Treatment A (contents of six 5-mg capsules of cinacalcet sprinkled over 4 oz of applesauce), and Treatment B (a single 30-mg tablet of cinacalcet with 4 oz of applesauce) in 1 of 2 sequences: AB or BA, separated by a washout period of at least 7 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cinacalcet Tablet
    Investigational medicinal product code
    Other name
    Sensipar® Mimpara®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    A single 30-mg oral dose of cinacalcet given as one 30-mg tablet swallowed whole with 240 mL of water following consumption of 4 oz of applesauce. The applesauce was consumed within 1 minute and dosing occurred within 1 minute of finishing the applesauce.

    Investigational medicinal product name
    Cinacalcet Capsules
    Investigational medicinal product code
    Other name
    Sensipar® Mimpara®
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    A single 30-mg oral dose of cinacalcet given as the contents of six 5-mg capsules sprinkled over 4 oz of applesauce and consumed within 1 minute with 240 mL of water.

    Number of subjects in period 1
    		Cinacalcet
    Started
    44
    Completed
    43
    Not completed
    1
         Decision by Sponsor
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    		 Participants received Treatment A (contents of six 5-mg capsules of cinacalcet sprinkled over 4 oz of applesauce), and Treatment B (a single 30-mg tablet of cinacalcet with 4 oz of applesauce) in 1 of 2 sequences: AB or BA, separated by a washout period of at least 7 days.

    Reporting group values
    		 Overall Study Total
    Number of subjects
    		 44 44
    Age Categorical
    Units: Subjects
        Adults (18-64 years)
    		 44 44
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 38.1 ( 9.5 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 4 4
        Male
    		 40 40
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 2 2
        Asian
    		 2 2
        Black or African American
    		 12 12
        Native Hawaiian or Other Pacific Islander
    		 0 0
        White
    		 27 27
        Other
    		 1 1
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 19 19
        Not Hispanic or Latino
    		 25 25

    End points

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    End points reporting groups
    Reporting group title
    Cinacalcet
    Reporting group description
    		 Participants received Treatment A (contents of six 5-mg capsules of cinacalcet sprinkled over 4 oz of applesauce), and Treatment B (a single 30-mg tablet of cinacalcet with 4 oz of applesauce) in 1 of 2 sequences: AB or BA, separated by a washout period of at least 7 days.

    Subject analysis set title
    Cinacalcet 30 mg Capsule
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants received a single 30-mg oral dose of cinacalcet given as the contents of six 5-mg capsules sprinkled over 4 oz of applesauce and consumed within 1 minute with 240 mL of water

    Subject analysis set title
    Cinacalcet 30 mg Tablet
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants received a single 30-mg oral dose of cinacalcet given as one 30-mg tablet swallowed whole with 240 mL of water following consumption of 4 oz of applesauce.

    Primary: Maximum Observed Plasma Concentration (Cmax) of Cinacalcet

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    End point title
    		 Maximum Observed Plasma Concentration (Cmax) of Cinacalcet
    End point description
    Cinacalcet in plasma samples was assessed using high performance liquid chromatography followed by tandem mass spectrometric detection (LC-MS/MS). Cinacalcet concentrations below the lower limit of quantitation (LLOQ, 0.100 ng/mL) were set to zero before data analysis.
    End point type
    Primary
    End point timeframe
    Predose and up to 72 hours post-dose
    End point values
    		 Cinacalcet 30 mg Capsule Cinacalcet 30 mg Tablet
    Number of subjects analysed
    44
    43
    Units: ng/mL
        arithmetic mean (standard deviation)
    6.07 ( 3.62 )
    5.97 ( 3.38 )
    Statistical analysis title
    		 Statistical Evaluation of Cmax
    Statistical analysis description
    Cmax was natural log-transformed and analyzed using a mixed-effect analysis of variance (ANOVA) model. The effects due to sequence, period, and formulation were evaluated as fixed effects, and subject within sequence was treated as a random effect. The mean difference and 90% CI between the 2 treatment formulations was calculated and then transformed back to report the ratio of the geometric means and the 90% CI of the ratio. The number of subjects included in the analysis is 43, not 87.
    Comparison groups
    Cinacalcet 30 mg Capsule v Cinacalcet 30 mg Tablet
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [1]
    Method
    Parameter type
    		 Ratio of Capsule:Tablet
    Point estimate
    0.998
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.885
         upper limit
    		 1.126
    Notes
    [1] - The two formulations administered in treatments A and B were considered bioequivalent if the 90% confidence intervals for the ratio of the Cmax, AUC0-t, and AUC0-inf geometric means were between 0.80 to 1.25.

    Primary: Area Under the Plasma Drug Concentration-Time Curve From Time Zero to The Time of the Last Quantifiable Concentration (AUClast)

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    End point title
    		 Area Under the Plasma Drug Concentration-Time Curve From Time Zero to The Time of the Last Quantifiable Concentration (AUClast)
    End point description
    The area under the plasma drug concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast), estimated using the linear trapezoidal method (for assessment of the AUC0-t endpoint).
    End point type
    Primary
    End point timeframe
    Predose to 72 hours post-dose
    End point values
    		 Cinacalcet 30 mg Capsule Cinacalcet 30 mg Tablet
    Number of subjects analysed
    44
    43
    Units: hr*ng/mL
        arithmetic mean (standard deviation)
    57.0 ( 34.0 )
    60.4 ( 39.1 )
    Statistical analysis title
    		 Statistical Evaluation of AUClast
    Statistical analysis description
    AUClast was natural log-transformed and analyzed using a mixed-effect ANOVA model. The effects due to sequence, period, and formulation were evaluated as fixed effects, and subject within sequence was treated as a random effect. The mean difference and the corresponding 90% CI between the 2 treatment formulations was calculated and then transformed back to report the ratio of the geometric means and the 90% CI of the ratio. The number of subjects included in the analysis is 43, not 87.
    Comparison groups
    Cinacalcet 30 mg Capsule v Cinacalcet 30 mg Tablet
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [2]
    Method
    Parameter type
    		 Ratio of Capsule:Tablet
    Point estimate
    0.945
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.861
         upper limit
    		 1.039
    Notes
    [2] - The two formulations administered in treatments A and B were considered bioequivalent if the 90% confidence intervals for the ratio of the Cmax, AUC0-t, and AUC0-inf geometric means were between 0.80 to 1.25.

    Primary: Area Under the Plasma Drug Concentration-Time Curve From Time Zero to Infinity (AUCinf)

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    End point title
    		 Area Under the Plasma Drug Concentration-Time Curve From Time Zero to Infinity (AUCinf)
    End point description
    End point type
    Primary
    End point timeframe
    Predose and up to 72 hours post-dose
    End point values
    		 Cinacalcet 30 mg Capsule Cinacalcet 30 mg Tablet
    Number of subjects analysed
    42
    43
    Units: hr*ng/mL
        arithmetic mean (standard deviation)
    63.5 ( 36.4 )
    66.1 ( 43.2 )
    Statistical analysis title
    		 Statistical Evaluation of AUCinf
    Statistical analysis description
    AUCinf was natural log-transformed and analyzed using a mixed-effect ANOVA model. The effects due to sequence, period, and formulation were evaluated as fixed effects, and subject within sequence was treated as a random effect. The mean difference and the corresponding 90% CI between the 2 treatment formulations was calculated and then transformed back to report the ratio of the geometric means and the 90% CI of the ratio. The number of subjects included in the analysis is 43, not 85.
    Comparison groups
    Cinacalcet 30 mg Capsule v Cinacalcet 30 mg Tablet
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [3]
    Method
    Parameter type
    		 Ratio of Capsule:Tablet
    Point estimate
    0.947
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.861
         upper limit
    		 1.042
    Notes
    [3] - The two formulations administered in treatments A and B were considered bioequivalent if the 90% confidence intervals for the ratio of the Cmax, AUC0-t, and AUC0-inf geometric means were between 0.80 to 1.25.

    Secondary: Number of Participants with Adverse Events

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    End point title
    		 Number of Participants with Adverse Events
    End point description
    The severity of each adverse event was graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 criteria.
    End point type
    Secondary
    End point timeframe
    From first dose of the investigational product in period 1 to day 14 (7 days in each treatment period).
    End point values
    		 Cinacalcet 30 mg Capsule Cinacalcet 30 mg Tablet
    Number of subjects analysed
    44
    43
    Units: participants
        Any adverse event (AE)
    8
    4
        AE Grade ≥ 2
    1
    0
        AE Grade ≥ 3
    0
    0
        AE Grade ≥ 4
    0
    0
        Serious adverse events (SAE)
    0
    0
        AE leading to discontinuation of cinacalcet
    0
    0
        Fatal adverse events
    0
    0
        Treatment-related adverse event
    3
    2
    No statistical analyses for this end point

    Secondary: Time to Maximum Observed Concentration of Cinacalcet

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    End point title
    		 Time to Maximum Observed Concentration of Cinacalcet
    End point description
    End point type
    Secondary
    End point timeframe
    Predose to 72 hours post-dose
    End point values
    		 Cinacalcet 30 mg Capsule Cinacalcet 30 mg Tablet
    Number of subjects analysed
    44
    43
    Units: hours
        median (full range (min-max))
    2.5 (1.0 to 6.0)
    3.5 (1.0 to 8.0)
    No statistical analyses for this end point

    Secondary: Half-life of Cinacalcet (T1/2)

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    End point title
    		 Half-life of Cinacalcet (T1/2)
    End point description
    End point type
    Secondary
    End point timeframe
    Predose to 72 hours post-dose
    End point values
    		 Cinacalcet 30 mg Capsule Cinacalcet 30 mg Tablet
    Number of subjects analysed
    42
    43
    Units: hours
        arithmetic mean (standard deviation)
    21.6 ( 9.58 )
    20.6 ( 9.19 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    14 Days (7 days in each treatment period)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Cinacalcet 30 mg Capsule
    Reporting group description
    		 Participants received a single 30-mg oral dose of cinacalcet given as the contents of six 5-mg capsules sprinkled over 4 oz of applesauce and consumed within 1 minute with 240 mL of water.

    Reporting group title
    Cinacalcet 30 mg Tablet
    Reporting group description
    		 Participants received a single 30-mg oral dose of cinacalcet given as one 30-mg tablet swallowed whole with 240 mL of water following consumption of 4 oz of applesauce.

    Reporting group title
    All Subjects
    Reporting group description
    		 Participants received Treatment A (contents of six 5-mg capsules of cinacalcet sprinkled over 4 oz of applesauce), and Treatment B (a single 30-mg tablet of cinacalcet with 4 oz of applesauce) in 1 of 2 sequences: AB or BA, separated by a washout period of at least 7 days.

    Serious adverse events
    		 Cinacalcet 30 mg Capsule Cinacalcet 30 mg Tablet All Subjects
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 43 (0.00%)
    0 / 44 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Cinacalcet 30 mg Capsule Cinacalcet 30 mg Tablet All Subjects
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 44 (18.18%)
    4 / 43 (9.30%)
    11 / 44 (25.00%)
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 43 (0.00%)
    1 / 44 (2.27%)
         occurrences all number
    1
    0
    1
    Laceration
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 43 (2.33%)
    1 / 44 (2.27%)
         occurrences all number
    0
    1
    1
    Skin abrasion
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 43 (0.00%)
    1 / 44 (2.27%)
         occurrences all number
    1
    0
    1
    Skin injury
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 43 (2.33%)
    1 / 44 (2.27%)
         occurrences all number
    0
    1
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 43 (0.00%)
    1 / 44 (2.27%)
         occurrences all number
    1
    0
    1
    Headache
         subjects affected / exposed
    3 / 44 (6.82%)
    0 / 43 (0.00%)
    3 / 44 (6.82%)
         occurrences all number
    3
    0
    3
    Somnolence
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 43 (2.33%)
    1 / 44 (2.27%)
         occurrences all number
    0
    1
    1
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 43 (0.00%)
    1 / 44 (2.27%)
         occurrences all number
    1
    0
    1
    Fatigue
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 43 (0.00%)
    1 / 44 (2.27%)
         occurrences all number
    1
    0
    1
    Ear and labyrinth disorders
    Ear discomfort
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 43 (0.00%)
    1 / 44 (2.27%)
         occurrences all number
    1
    0
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    2 / 44 (4.55%)
    0 / 43 (0.00%)
    2 / 44 (4.55%)
         occurrences all number
    2
    0
    2
    Diarrhoea
         subjects affected / exposed
    2 / 44 (4.55%)
    1 / 43 (2.33%)
    2 / 44 (4.55%)
         occurrences all number
    2
    1
    3
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 44 (2.27%)
    1 / 43 (2.33%)
    2 / 44 (4.55%)
         occurrences all number
    1
    1
    2
    Nausea
         subjects affected / exposed
    1 / 44 (2.27%)
    1 / 43 (2.33%)
    2 / 44 (4.55%)
         occurrences all number
    1
    1
    2
    Vomiting
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 43 (0.00%)
    1 / 44 (2.27%)
         occurrences all number
    1
    0
    1
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 43 (2.33%)
    1 / 44 (2.27%)
         occurrences all number
    0
    1
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 43 (0.00%)
    1 / 44 (2.27%)
         occurrences all number
    1
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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