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    Clinical Trial Results:
    A Phase II Randomized Clinical Trial to Study the Efficacy and Safety of MK-5172 in Combination with Ribavirin (RBV) in Subjects with Chronic Hepatitis C Virus Infection

    Summary
    EudraCT number
    		 2012-003340-72
    Trial protocol
    		 AT   ES   NO  
    Global end of trial date
    12 Mar 2014

    Results information
    Results version number
    		 v2(current)
    This version publication date
    15 Apr 2016
    First version publication date
    01 Mar 2015
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    5172-039
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01716156
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.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
    12 Mar 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Mar 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Mar 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1) To evaluate the efficacy of each treatment arm of grazoprevir (MK-5172) in combination with ribavarin (RBV) for 12 or 24 weeks as assessed by the percentage of participants achieving SVR12 (Sustained Virologic Response 12 weeks after the end of all study therapy), defined as hepatitis C virus (HCV) ribonucleic acid (RNA) <25 IU/mL (either "target detectable but unquantifiable" [TD(u)] or "target not detected" [TND]) 12 weeks after the end of all study therapy. 2) To evaluate the safety and tolerability of grazoprevir in combination with RBV.
    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. The following additional measure defined for this individual study was in place for the protection of trial subjects: Peg-IFN (1.5 μg/kg/wk) + RBV (weight-based) was offered as rescue therapy to any participant who met the criteria for virologic failure and futility or discontinued study medications due to safety concerns that were not attributed to RBV. Participants had to start on rescue within 4 months from the time of discontinuing therapy or within 4 months of follow-up week 24 in case of relapse, if indicated.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Jan 2013
    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
    Australia: 6
    Country: Number of subjects enrolled
    Israel: 18
    Country: Number of subjects enrolled
    New Zealand: 2
    Worldwide total number of subjects
    26
    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)
    25
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 26 treatment-naïve, non-cirrhotic, adult participants with HCV genotype 1 were recruited in Australia, Israel, and New Zealand.

    Pre-assignment
    Screening details
    		 Participants received grazoprevir + RBV for either 12 weeks or 24 weeks (participants in the 12-week arm with detectable HCV RNA at Treatment Week [TW] 4 received 12 additional weeks of study treatment). The allocation of participants to the 2 arms was stratified according to HCV GT1a vs. GT1b infection.

    Period 1
    Period 1 title
    Treatment (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    This was an open-label study.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Grazoprevir 100 mg + RBV 12 Weeks
    Arm description
    		 Grazoprevir 100 mg tablet once per day by mouth, and RBV capsules twice per day at a total daily dose from 800 to 1400 mg based on participant body weight, for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Rebetol™
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    RBV 200 mg capsules twice daily by mouth at a total daily dose of 800 mg/day to 1400 mg/day based on participant body weight on Day 1.

    Investigational medicinal product name
    Grazoprevir
    Investigational medicinal product code
    Other name
    MK-5172
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Grazoprevir 100 mg tablet once daily by mouth for 12 or 24 weeks.

    Arm title
    		 Grazoprevir 100 mg + RBV 12 Weeks Extended
    Arm description
    		 Grazoprevir 100 mg tablet once per day by mouth, and RBV capsules twice per day at a total daily dose from 800 to 1400 mg based on participant body weight, for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 week of treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Grazoprevir
    Investigational medicinal product code
    Other name
    MK-5172
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Grazoprevir 100 mg tablet once daily by mouth for 12 or 24 weeks.

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Rebetol™
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    RBV 200 mg capsules twice daily by mouth at a total daily dose of 800 mg/day to 1400 mg/day based on participant body weight on Day 1.

    Arm title
    		 Grazoprevir 100 mg + RBV 24 Weeks
    Arm description
    		 Grazoprevir 100 mg tablet once per day by mouth, and RBV capsules twice per day at a total daily dose from 800 to 1400 mg based on participant body weight, for 24 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Rebetol™
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    RBV 200 mg capsules twice daily by mouth at a total daily dose of 800 mg/day to 1400 mg/day based on participant body weight on Day 1.

    Investigational medicinal product name
    Grazoprevir
    Investigational medicinal product code
    Other name
    MK-5172
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Grazoprevir 100 mg tablet once daily by mouth for 12 or 24 weeks.

    Number of subjects in period 1
    		Grazoprevir 100 mg + RBV 12 Weeks Grazoprevir 100 mg + RBV 12 Weeks Extended Grazoprevir 100 mg + RBV 24 Weeks
    Started
    9
    4
    13
    Completed
    7
    3
    11
    Not completed
    2
    1
    2
         Consent withdrawn by subject
    -
    1
    2
         Lost to follow-up
    1
    -
    -
         Protocol deviation
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Grazoprevir 100 mg + RBV 12 Weeks
    Reporting group description
    		 Grazoprevir 100 mg tablet once per day by mouth, and RBV capsules twice per day at a total daily dose from 800 to 1400 mg based on participant body weight, for 12 weeks.

    Reporting group title
    Grazoprevir 100 mg + RBV 12 Weeks Extended
    Reporting group description
    		 Grazoprevir 100 mg tablet once per day by mouth, and RBV capsules twice per day at a total daily dose from 800 to 1400 mg based on participant body weight, for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 week of treatment.

    Reporting group title
    Grazoprevir 100 mg + RBV 24 Weeks
    Reporting group description
    		 Grazoprevir 100 mg tablet once per day by mouth, and RBV capsules twice per day at a total daily dose from 800 to 1400 mg based on participant body weight, for 24 weeks.

    Reporting group values
    		 Grazoprevir 100 mg + RBV 12 Weeks Grazoprevir 100 mg + RBV 12 Weeks Extended Grazoprevir 100 mg + RBV 24 Weeks Total
    Number of subjects
    		 9 4 13 26
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 8 4 13 25
        From 65-84 years
    		 1 0 0 1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 44.1 ( 13.2 ) 42.3 ( 7.4 ) 42.8 ( 14.8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 2 1 6 9
        Male
    		 7 3 7 17

    End points

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    End points reporting groups
    Reporting group title
    Grazoprevir 100 mg + RBV 12 Weeks
    Reporting group description
    		 Grazoprevir 100 mg tablet once per day by mouth, and RBV capsules twice per day at a total daily dose from 800 to 1400 mg based on participant body weight, for 12 weeks.

    Reporting group title
    Grazoprevir 100 mg + RBV 12 Weeks Extended
    Reporting group description
    		 Grazoprevir 100 mg tablet once per day by mouth, and RBV capsules twice per day at a total daily dose from 800 to 1400 mg based on participant body weight, for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 week of treatment.

    Reporting group title
    Grazoprevir 100 mg + RBV 24 Weeks
    Reporting group description
    		 Grazoprevir 100 mg tablet once per day by mouth, and RBV capsules twice per day at a total daily dose from 800 to 1400 mg based on participant body weight, for 24 weeks.

    Subject analysis set title
    Grazoprevir 100 mg + RBV: HCV GT1a
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    This group consisted of all participants with HCV GT1a infection pooled across treatment arms.

    Subject analysis set title
    Grazoprevir 100 mg + RBV: HCV GT1non-a
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    This group consisted of all participants with HCV GT1non-a infection, pooled across treatment arms.

    Subject analysis set title
    Grazoprevir 100 mg + RBV: Up to 12 Weeks
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The All Patients as Treated (APaT) population included all randomized participants who received at least 1 dose of study therapy. The 12-week group consists of participants in the APaT who only received 12 weeks of treatment and not those originally assigned to 12 weeks that went on to receive 24 total weeks of treatment.

    Subject analysis set title
    Grazoprevir 100 mg + RBV: Beyond 12 Weeks
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The APaT population included all randomized participants who received at least 1 dose of study therapy. The 24-week group consists of participants in the APaT who received 24 total weeks of treatment, regardless of original treatment regimen assignment.

    Primary: Percentage of participants with undetectable HCV ribonucleic acid (RNA) 12 weeks after completing study therapy (SVR12)

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    End point title
    		 Percentage of participants with undetectable HCV ribonucleic acid (RNA) 12 weeks after completing study therapy (SVR12) [1]
    End point description
    HCV RNA was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR12 was defined as Hepatitis C Virus (HCV) ribonucleic acid (RNA) <25 IU/mL 12 weeks after the end of all study therapy.
    End point type
    Primary
    End point timeframe
    Up to 36 weeks
    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: Per protocol, only descriptive statistics are presented.
    End point values
    		 Grazoprevir 100 mg + RBV 12 Weeks Grazoprevir 100 mg + RBV 12 Weeks Extended Grazoprevir 100 mg + RBV 24 Weeks
    Number of subjects analysed
    8 [2]
    4 [3]
    10 [4]
    Units: percentage of participants
        number (confidence interval 95%)
    62.5 (24.5 to 91.5)
    50 (6.8 to 93.2)
    90 (55.5 to 99.7)
    Notes
    [2] - All randomized participants receiving ≥1 dose of study therapy and no important protocol deviations.
    [3] - All randomized participants receiving ≥1 dose of study therapy and no important protocol deviations.
    [4] - All randomized participants receiving ≥1 dose of study therapy and no important protocol deviations.
    No statistical analyses for this end point

    Primary: Percentage of participants experiencing an adverse event (AE)

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    End point title
    		 Percentage of participants experiencing an adverse event (AE) [5]
    End point description
    An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an adverse event. Data are presented according to actual treatment duration (12 weeks or 24 weeks) regardless of participants' initial arm assignment.
    End point type
    Primary
    End point timeframe
    Up to 14 days following last dose of study drug (up to 26 weeks).
    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: Per protocol, only descriptive statistics are presented.
    End point values
    		 Grazoprevir 100 mg + RBV: Up to 12 Weeks Grazoprevir 100 mg + RBV: Beyond 12 Weeks
    Number of subjects analysed
    11
    15
    Units: percentage of participants
        number (not applicable)
    72.7
    86.7
    No statistical analyses for this end point

    Primary: Percentage of participants discontinuing from study therapy due to AE(s)

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    End point title
    		 Percentage of participants discontinuing from study therapy due to AE(s) [6]
    End point description
    An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an adverse event. Data are presented according to actual treatment duration (12 weeks or 24 weeks) regardless of participants' initial arm assignment.
    End point type
    Primary
    End point timeframe
    Up to 24 weeks
    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: Per protocol, only descriptive statistics are presented.
    End point values
    		 Grazoprevir 100 mg + RBV: Up to 12 Weeks Grazoprevir 100 mg + RBV: Beyond 12 Weeks
    Number of subjects analysed
    11
    15
    Units: percentage of participants
        number (not applicable)
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of participants with undetectable HCV RNA by time point

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    End point title
    		 Percentage of participants with undetectable HCV RNA by time point
    End point description
    HCV RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay on blood samples drawn from each participant at Week 2, Week 4, Week 12, and at end of treatment (End of Treatment Response). The assay has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. Undetectable HCV RNA was defined as below the limit of detection of 9.3 IU/mL.
    End point type
    Secondary
    End point timeframe
    From Week 2 through end of treatment (up to 24 weeks)
    End point values
    		 Grazoprevir 100 mg + RBV 12 Weeks Grazoprevir 100 mg + RBV 12 Weeks Extended Grazoprevir 100 mg + RBV 24 Weeks
    Number of subjects analysed
    8
    4
    12 [7]
    Units: percentage of participants
    number (confidence interval 95%)
        Week 2
    50 (15.7 to 84.3)
    0 (0 to 60.2)
    41.7 (15.2 to 72.3)
        Week 4
    100 (63.1 to 100)
    0 (0 to 60.2)
    81.8 (48.2 to 97.7)
        Week 12
    100 (63.1 to 100)
    75 (19.4 to 99.4)
    81.8 (48.2 to 97.7)
        End of All Therapy
    100 (63.1 to 100)
    75 (19.4 to 99.4)
    91.7 (61.5 to 99.8)
    Notes
    [7] - One participant did not have HCV RNA data available at Week 4 (n=11) and at Week 12 (n=11).
    No statistical analyses for this end point

    Secondary: Percentage of participants with HCV RNA <25 IU/mL by time point

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    End point title
    		 Percentage of participants with HCV RNA <25 IU/mL by time point
    End point description
    HCV RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay on blood samples drawn from each participant at Week 2, Week 4, Week 12, and at end of treatment (End of Treatment Response). The assay has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. Undetectable HCV RNA was defined as below the limit of detection of 9.3 IU/mL.
    End point type
    Secondary
    End point timeframe
    From Week 2 through end of treatment (up to 24 weeks).
    End point values
    		 Grazoprevir 100 mg + RBV 12 Weeks Grazoprevir 100 mg + RBV 12 Weeks Extended Grazoprevir 100 mg + RBV 24 Weeks
    Number of subjects analysed
    8
    4
    12 [8]
    Units: percentage of participants
    number (confidence interval 95%)
        Week 2
    100 (63.1 to 100)
    75 (19.4 to 99.4)
    100 (73.5 to 100)
        Week 4
    100 (63.1 to 100)
    100 (39.8 to 100)
    100 (71.5 to 100)
        Week 12
    100 (63.1 to 100)
    75 (19.4 to 99.4)
    90.9 (58.7 to 99.8)
        End of All Therapy
    100 (63.1 to 100)
    75 (19.4 to 99.4)
    91.7 (61.5 to 99.8)
    Notes
    [8] - One participant did not have HCV RNA data available at Week 4 (n=11) and Week 12 (n=11).
    No statistical analyses for this end point

    Secondary: Percentage of participants with sustained virologic response 4 weeks after ending study therapy (SVR4)

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    End point title
    		 Percentage of participants with sustained virologic response 4 weeks after ending study therapy (SVR4)
    End point description
    HCV RNA was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR4 was defined as HCV RNA <25 IU/mL 4 weeks after the end of all study therapy.
    End point type
    Secondary
    End point timeframe
    Up to Week 28
    End point values
    		 Grazoprevir 100 mg + RBV 12 Weeks Grazoprevir 100 mg + RBV 12 Weeks Extended Grazoprevir 100 mg + RBV 24 Weeks
    Number of subjects analysed
    8
    4
    11
    Units: percentage of participants
        number (confidence interval 95%)
    87.5 (47.3 to 99.7)
    75 (19.4 to 99.4)
    90.9 (58.7 to 99.8)
    No statistical analyses for this end point

    Secondary: Percentage of participants achieving sustained virologic response 24 weeks after the end of study therapy

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    End point title
    		 Percentage of participants achieving sustained virologic response 24 weeks after the end of study therapy
    End point description
    HCV RNA was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR24 was defined as HCV RNA <25 IU/mL 24 weeks after the end of all study therapy.
    End point type
    Secondary
    End point timeframe
    Up to Week 48
    End point values
    		 Grazoprevir 100 mg + RBV 12 Weeks Grazoprevir 100 mg + RBV 12 Weeks Extended Grazoprevir 100 mg + RBV 24 Weeks
    Number of subjects analysed
    8
    4
    10
    Units: percentage of participants
        number (confidence interval 95%)
    62.5 (24.5 to 91.5)
    50 (6.8 to 93.2)
    80 (44.4 to 97.5)
    No statistical analyses for this end point

    Secondary: Time to achievement of first undetectable HCV RNA

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    End point title
    		 Time to achievement of first undetectable HCV RNA
    End point description
    The mean time (in days) to first achievement of undetectable HCV RNA was assessed using Kaplan-Meier plot and summary statistics. HCV RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay on blood samples drawn from each participant at Week 2, Week 4, Week 12, and at end of treatment. The assay has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. Undetectable HCV RNA was defined as below the limit of detection of 9.3 IU/mL.
    End point type
    Secondary
    End point timeframe
    Up to Week 24
    End point values
    		 Grazoprevir 100 mg + RBV: HCV GT1a Grazoprevir 100 mg + RBV: HCV GT1non-a
    Number of subjects analysed
    12
    14
    Units: day
        least squares mean (standard error)
    27.1 ( 2.5 )
    19.7 ( 2.8 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first day of treatment (Day 1) through Day 14 of follow-up (up to 26 weeks)
    Adverse event reporting additional description
    All randomized participants who received at least one dose of study treatment. Participants are included in the arm according to the duration of treatment received.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    MK-5172 100 mg + RBV 24 Weeks
    Reporting group description
    		 This group consists of all participants receiving 24 weeks of study therapy.

    Reporting group title
    MK-5172 100 mg + RBV 12 Weeks
    Reporting group description
    		 This group consists of all participants who received only 12 weeks of study therapy.

    Serious adverse events
    		 MK-5172 100 mg + RBV 24 Weeks MK-5172 100 mg + RBV 12 Weeks
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 11 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 MK-5172 100 mg + RBV 24 Weeks MK-5172 100 mg + RBV 12 Weeks
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 15 (86.67%)
    8 / 11 (72.73%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    2
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    8 / 15 (53.33%)
    0 / 11 (0.00%)
         occurrences all number
    8
    0
    Irritability
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Chest pain
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Chills
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 11 (0.00%)
         occurrences all number
    2
    0
    Fatigue
         subjects affected / exposed
    3 / 15 (20.00%)
    1 / 11 (9.09%)
         occurrences all number
    3
    1
    Pyrexia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Cough
         subjects affected / exposed
    0 / 15 (0.00%)
    2 / 11 (18.18%)
         occurrences all number
    0
    2
    Oropharyngeal pain
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Affective disorder
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Insomnia
         subjects affected / exposed
    3 / 15 (20.00%)
    1 / 11 (9.09%)
         occurrences all number
    3
    1
    Depression
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Weight decreased
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 11 (9.09%)
         occurrences all number
    1
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 15 (26.67%)
    4 / 11 (36.36%)
         occurrences all number
    6
    10
    Dizziness
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 15 (6.67%)
    2 / 11 (18.18%)
         occurrences all number
    1
    2
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 11 (9.09%)
         occurrences all number
    1
    1
    Eye disorders
    Eye inflammation
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 11 (9.09%)
         occurrences all number
    1
    1
    Abdominal pain lower
         subjects affected / exposed
    2 / 15 (13.33%)
    0 / 11 (0.00%)
         occurrences all number
    2
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Constipation
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Dry mouth
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 11 (9.09%)
         occurrences all number
    1
    1
    Dyspepsia
         subjects affected / exposed
    2 / 15 (13.33%)
    2 / 11 (18.18%)
         occurrences all number
    4
    3
    Frequent bowel movements
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Gastritis
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Diarrhoea
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 11 (9.09%)
         occurrences all number
    1
    1
    Paraesthesia oral
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Flatulence
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Lip dry
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Vomiting
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    1 / 15 (6.67%)
    2 / 11 (18.18%)
         occurrences all number
    3
    2
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Dry skin
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Rash
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 11 (9.09%)
         occurrences all number
    1
    1
    Pruritus
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 11 (9.09%)
         occurrences all number
    1
    1
    Hyperhidrosis
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Muscle spasms
         subjects affected / exposed
    3 / 15 (20.00%)
    0 / 11 (0.00%)
         occurrences all number
    4
    0
    Back pain
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 11 (9.09%)
         occurrences all number
    1
    2
    Pain in extremity
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal pain
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Myalgia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Neck pain
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Pain in jaw
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 11 (9.09%)
         occurrences all number
    1
    1
    Rhinitis
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    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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    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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