Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43862   clinical trials with a EudraCT protocol, of which   7285   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Phase 1 Relative Bioavailability and Food Effect Study of a Pediatric Oral Granule Formulation of SOF/VEL in Healthy Adult Subjects

    Summary
    EudraCT number
    		 2017-004044-37
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    23 Oct 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Nov 2018
    First version publication date
    03 Nov 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    GS-US-342-1142
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Gilead Sciences
    Sponsor organisation address
    333 Lakeside Drive, Foster City, CA, United States, 94404
    Public contact
    Gilead Clinical Study Information Center, Gilead Sciences , GileadClinicalTrials@gilead.com
    Scientific contact
    Gilead Clinical Study Information Center, Gilead Sciences , GileadClinicalTrials@gilead.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001646-PIP01-14
    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
    23 Oct 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Oct 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Oct 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objectives of this study were to evaluate the relative bioavailability of a pediatric oral granule formulation of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) relative to tablet formulation and to evaluate the effect of concomitant food intake on the pharmacokinetics of a pediatric granule formulation of SOF/VEL.
    Protection of trial subjects
    The protocol and consent/assent forms were submitted by each investigator to a duly constituted Independent Ethics Committee (IEC) or Institutional Review Board (IRB) for review and approval before study initiation. All revisions to the consent/assent forms (if applicable) after initial IEC/IRB approval were submitted by the investigator to the IEC/IRB for review and approval before implementation in accordance with regulatory requirements. This study was conducted in accordance with recognized international scientific and ethical standards, including but not limited to the International Conference on Harmonization guideline for Good Clinical Practice (ICH GCP) and the original principles embodied in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Mar 2017
    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: 112
    Worldwide total number of subjects
    112
    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)
    112
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Participants were enrolled at 1 study site in the United States. The first participant was screened on 27 March 2017. The last study visit occurred on 23 October 2017.

    Pre-assignment
    Screening details
    		 187 participants were screened.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treatment AB
    Arm description
    		 Treatment A, 8-day washout, and then Treatment B.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sofosbuvir/velpatasvir
    Investigational medicinal product code
    Other name
    Epclusa®, SOF/VEL, GS-7977/GS-5816
    Pharmaceutical forms
    Granules, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Treatment A: Single dose of SOF/VEL (400/100 mg tablet) under fasted conditions; Treatment B: Single dose of SOF/VEL (8 x 50/12.5 mg oral granules; FDC1 - 20% taste-mask coating) under fasted conditions

    Arm title
    		 Treatment BA
    Arm description
    		 Treatment B, 8-day washout, and then Treatment A.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sofosbuvir/velpatasvir
    Investigational medicinal product code
    Other name
    Epclusa®, SOF/VEL, GS-7977/GS-5816
    Pharmaceutical forms
    Granules, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Treatment B: Single dose of SOF/VEL (8 x 50/12.5 mg oral granules; FDC1 - 20% taste-mask coating) under fasted conditions; Treatment A: Single dose of SOF/VEL (400/100 mg tablet) under fasted conditions

    Arm title
    		 Treatment ACG
    Arm description
    		 Treatment A, 8-day washout, Treatment C, 8-day washout, and then Treatment G.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sofosbuvir/velpatasvir
    Investigational medicinal product code
    Other name
    Epclusa®, SOF/VEL, GS-7977/GS-5816
    Pharmaceutical forms
    Granules, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Treatment A: Single dose of SOF/VEL (400/100 mg tablet) under fasted conditions; Treatment C: Single dose of SOF/VEL (8 x 50/12.5 mg oral granules; FDC2 - 5% taste-mask coating) under fasted conditions; Treatment G: Single dose of SOF/VEL (8 x 50/12.5 mg oral granules; FDC2 - 5% taste-mask coating) under fed conditions

    Arm title
    		 Treatment CAG
    Arm description
    		 Treatment C, 8-day washout, Treatment A, 8-day washout, and then Treatment G.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sofosbuvir/velpatasvir
    Investigational medicinal product code
    Other name
    Epclusa®, SOF/VEL, GS-7977/GS-5816
    Pharmaceutical forms
    Granules, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Treatment C: Single dose of SOF/VEL (8 x 50/12.5 mg oral granules; FDC2 - 5% taste-mask coating) under fasted conditions; Treatment A: Single dose of SOF/VEL (400/100 mg tablet) under fasted conditions; Treatment G: Single dose of SOF/VEL (8 x 50/12.5 mg oral granules; FDC2 - 5% taste-mask coating) under fed conditions

    Number of subjects in period 1
    		Treatment AB Treatment BA Treatment ACG Treatment CAG
    Started
    28
    28
    28
    28
    Completed
    28
    28
    28
    28

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Treatment AB
    Reporting group description
    		 Treatment A, 8-day washout, and then Treatment B.

    Reporting group title
    Treatment BA
    Reporting group description
    		 Treatment B, 8-day washout, and then Treatment A.

    Reporting group title
    Treatment ACG
    Reporting group description
    		 Treatment A, 8-day washout, Treatment C, 8-day washout, and then Treatment G.

    Reporting group title
    Treatment CAG
    Reporting group description
    		 Treatment C, 8-day washout, Treatment A, 8-day washout, and then Treatment G.

    Reporting group values
    		 Treatment AB Treatment BA Treatment ACG Treatment CAG Total
    Number of subjects
    		 28 28 28 28 112
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 34 ± 7.5 34 ± 7.4 35 ± 7.2 35 ± 7.7 -
    Gender categorical
    Units: Subjects
        Female
    		 13 12 10 8 43
        Male
    		 15 16 18 20 69
    Race
    Units: Subjects
        Black or African American
    		 10 9 11 10 40
        White
    		 18 19 17 18 72
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 21 21 23 19 84
        Not Hispanic or Latino
    		 7 7 5 9 28

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Treatment AB
    Reporting group description
    		 Treatment A, 8-day washout, and then Treatment B.

    Reporting group title
    Treatment BA
    Reporting group description
    		 Treatment B, 8-day washout, and then Treatment A.

    Reporting group title
    Treatment ACG
    Reporting group description
    		 Treatment A, 8-day washout, Treatment C, 8-day washout, and then Treatment G.

    Reporting group title
    Treatment CAG
    Reporting group description
    		 Treatment C, 8-day washout, Treatment A, 8-day washout, and then Treatment G.

    Subject analysis set title
    Cohort 1, Treatment A
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Single dose of SOF/VEL (400/100 mg tablet) under fasted conditions

    Subject analysis set title
    Cohort 1, Treatment B
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Single dose of SOF/VEL (8 x 50/12.5 mg oral granules; FDC1 - 20% taste-mask coating) under fasted conditions

    Subject analysis set title
    Cohort 2, Treatment A
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Single dose of SOF/VEL (400/100 mg tablet) under fasted conditions

    Subject analysis set title
    Cohort 2, Treatment C
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Single dose of SOF/VEL (8 x 50/12.5 mg oral granules; FDC2 - 5% taste-mask coating) under fasted conditions

    Subject analysis set title
    Cohort 2, Treatment G
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Single dose of SOF/VEL (8 x 50/12.5 mg oral granules; FDC2 - 5% taste-mask coating) under fed conditions

    Subject analysis set title
    Cohorts 1 and 2, Treatment A
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Single dose of SOF/VEL (400/100 mg tablet) under fasted conditions

    Primary: Pharmacokinetic (PK) Parameter: AUCinf of VEL, GS-331007, SOF, and GS-566500

    		 Close Top of page
    End point title
    		 Pharmacokinetic (PK) Parameter: AUCinf of VEL, GS-331007, SOF, and GS-566500 [1]
    End point description
    AUCinf is defined as the concentration of drug extrapolated to infinite time. Participants in the PK Analysis Set (all randomized participants who took at least 1 dose of study drug and had at least 1 nonmissing postdose concentration value reported for the corresponding analyte) with available data were analyzed.
    End point type
    Primary
    End point timeframe
    Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96 and 120 hours postdose on Days 1 and 10 (all cohorts) and Day 19 (Cohorts 2)
    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: The statistical analysis of this primary endpoint is provided in the attachment.
    End point values
    		 Cohort 1, Treatment A Cohort 1, Treatment B Cohort 2, Treatment A Cohort 2, Treatment C Cohort 2, Treatment G
    Number of subjects analysed
    56
    56
    56
    56 [2]
    56
    Units: h*ng/mL
    arithmetic mean (standard deviation)
        VEL
    4294.8 ± 1592.02
    2991.7 ± 1389.73
    4113.1 ± 2552.71
    3782.7 ± 2117.47
    3957.5 ± 1742.21
        GS-331007
    12396.5 ± 2502.62
    11864.5 ± 2691.27
    11721.6 ± 2856.44
    11910.3 ± 2656.29
    12341.7 ± 2707.27
        SOF
    1938.6 ± 515.08
    1287.8 ± 488.60
    1744.5 ± 946.53
    1640.4 ± 725.66
    2523.7 ± 903.08
        GS-566500
    2174.8 ± 482.64
    1626.1 ± 521.60
    1968.8 ± 720.73
    1917.2 ± 665.94
    2777.5 ± 516.80
    Attachments
    		 Statistical Comparisons
    Notes
    [2] - For SOF, only 54 participants were included.
    No statistical analyses for this end point

    Primary: PK Parameter: AUClast of VEL, GS-331007, SOF, and GS-566500

    		 Close Top of page
    End point title
    		 PK Parameter: AUClast of VEL, GS-331007, SOF, and GS-566500 [3]
    End point description
    AUClast is defined as the concentration of drug from time zero to the last observable concentration. Participants in the PK Analysis Set were analyzed.
    End point type
    Primary
    End point timeframe
    Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96 and 120 hours postdose on Days 1 and 10 (all cohorts) and Day 19 (Cohorts 2)
    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: The statistical analysis of this primary endpoint is provided in the attachment.
    End point values
    		 Cohort 1, Treatment A Cohort 1, Treatment B Cohort 2, Treatment A Cohort 2, Treatment C Cohort 2, Treatment G
    Number of subjects analysed
    56
    56
    56
    56
    56
    Units: h*ng/mL
    arithmetic mean (standard deviation)
        VEL
    4250.9 ± 1584.23
    2951.8 ± 1378.59
    4068.8 ± 2539.06
    3740.3 ± 2111.97
    3906.8 ± 1717.54
        GS-331007
    11822.5 ± 2487.44
    11264.0 ± 2623.87
    11077.1 ± 2841.00
    11315.9 ± 2699.62
    11678.3 ± 2564.27
        SOF
    1924.9 ± 514.38
    1255.7 ± 458.62
    1730.4 ± 943.58
    1598.3 ± 728.94
    2494.5 ± 901.25
        GS-566500
    2120.5 ± 475.68
    1575.7 ± 514.86
    1912.3 ± 712.23
    1868.2 ± 661.38
    2719.5 ± 515.94
    Attachments
    		 Statistical Comparisons
    No statistical analyses for this end point

    Primary: PK Parameter: Cmax of VEL, GS-331007, SOF, and GS-566500

    		 Close Top of page
    End point title
    		 PK Parameter: Cmax of VEL, GS-331007, SOF, and GS-566500 [4]
    End point description
    Cmax is defined as the maximum concentration of drug. Participants in the PK Analysis Set were analyzed.
    End point type
    Primary
    End point timeframe
    Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96 and 120 hours postdose on Days 1 and 10 (all cohorts) and Day 19 (Cohorts 2)
    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: The statistical analysis of this primary endpoint is provided in the attachment.
    End point values
    		 Cohort 1, Treatment A Cohort 1, Treatment B Cohort 2, Treatment A Cohort 2, Treatment C Cohort 2, Treatment G
    Number of subjects analysed
    56
    56
    56
    56
    56
    Units: ng/mL
    arithmetic mean (standard deviation)
        VEL
    533.9 ± 194.58
    359.2 ± 144.92
    497.3 ± 287.90
    476.5 ± 247.46
    407.1 ± 133.36
        GS-331007
    944.3 ± 309.05
    1105.0 ± 303.95
    910.3 ± 265.68
    988.2 ± 241.28
    621.9 ± 126.46
        SOF
    1558.1 ± 500.39
    906.6 ± 394.83
    1474.6 ± 736.18
    1171.8 ± 525.01
    1194.1 ± 513.66
        GS-566500
    548.7 ± 121.54
    395.6 ± 123.23
    491.8 ± 192.16
    468.8 ± 166.42
    530.1 ± 112.28
    Attachments
    		 Statistical Comparisons
    No statistical analyses for this end point

    Secondary: Percentage of Participants Experiencing Any Treatment-Emergent Adverse Event

    		 Close Top of page
    End point title
    		 Percentage of Participants Experiencing Any Treatment-Emergent Adverse Event
    End point description
    Safety Analysis Set included all participants who took at least 1 dose of study drug. Participants were grouped according to the treatment they received.
    End point type
    Secondary
    End point timeframe
    Up to Day 19 plus 30 days
    End point values
    		 Cohort 1, Treatment B Cohort 2, Treatment C Cohort 2, Treatment G Cohorts 1 and 2, Treatment A
    Number of subjects analysed
    56
    56
    56
    112
    Units: percentage of participants
        number (not applicable)
    1.8
    5.4
    3.6
    7.1
    No statistical analyses for this end point

    Secondary: Percentage of Participants Experiencing Grade 3 or 4 Laboratory Abnormalities

    		 Close Top of page
    End point title
    		 Percentage of Participants Experiencing Grade 3 or 4 Laboratory Abnormalities
    End point description
    Participants in the Safety Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to Day 19 plus 30 days
    End point values
    		 Cohort 1, Treatment B Cohort 2, Treatment C Cohort 2, Treatment G Cohorts 1 and 2, Treatment A
    Number of subjects analysed
    56
    56
    56
    112
    Units: percentage of participants
    number (not applicable)
        Grade 3
    1.8
    1.8
    1.8
    2.7
        Grade 4
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Palatability of SOF/VEL

    		 Close Top of page
    End point title
    		 Palatability of SOF/VEL
    End point description
    The percentage of participants who rated the taste of each treatment as palatable are presented. Participants in the Safety Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to Day 19
    End point values
    		 Cohort 1, Treatment B Cohort 2, Treatment C Cohort 2, Treatment G Cohorts 1 and 2, Treatment A
    Number of subjects analysed
    56
    56
    56
    112 [5]
    Units: percentage of participants
        number (not applicable)
    96.4
    85.7
    92.9
    81.3
    Notes
    [5] - Note: Data was missing for 14 participants in this group.
    No statistical analyses for this end point

    Secondary: PK Parameter: Tmax of VEL, GS-331007, SOF, and GS-566500

    		 Close Top of page
    End point title
    		 PK Parameter: Tmax of VEL, GS-331007, SOF, and GS-566500
    End point description
    Tmax is defined as the time (observed time point) of Cmax. Participants in the PK Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96 and 120 hours postdose on Days 1 and 10 (all cohorts) and Day 19 (Cohorts 2)
    End point values
    		 Cohort 1, Treatment A Cohort 1, Treatment B Cohort 2, Treatment A Cohort 2, Treatment C Cohort 2, Treatment G
    Number of subjects analysed
    56
    56
    56
    56
    56
    Units: hours
    median (inter-quartile range (Q1-Q3))
        VEL
    1.00 (0.5 to 1.50)
    1.50 (1.00 to 2.00)
    0.77 (0.50 to 1.00)
    1.00 (0.50 to 1.50)
    2.00 (1.50 to 2.00)
        GS-331007
    3.00 (2.00 to 3.00)
    3.00 (2.50 to 4.00)
    3.00 (2.00 to 4.00)
    2.50 (2.00 to 3.00)
    4.00 (4.00 to 4.00)
        SOF
    1.00 (0.50 to 1.50)
    1.50 (1.00 to 2.00)
    0.77 (0.50 to 1.00)
    1.00 (0.50 to 1.50)
    2.00 (1.50 to 2.00)
        GS-566500
    1.50 (1.25 to 2.00)
    2.00 (1.76 to 3.00)
    2.00 (1.00 to 2.00)
    2.00 (1.50 to 3.00)
    3.00 (2.00 to 4.00)
    No statistical analyses for this end point

    Secondary: PK Parameter: Clast of VEL, GS-331007, SOF, and GS-566500

    		 Close Top of page
    End point title
    		 PK Parameter: Clast of VEL, GS-331007, SOF, and GS-566500
    End point description
    Clast is defined as the last observable concentration of drug. Participants in the PK Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96 and 120 hours postdose on Days 1 and 10 (all cohorts) and Day 19 (Cohorts 2)
    End point values
    		 Cohort 1, Treatment A Cohort 1, Treatment B Cohort 2, Treatment A Cohort 2, Treatment C Cohort 2, Treatment G
    Number of subjects analysed
    56
    56
    56
    56
    56
    Units: ng/mL
    arithmetic mean (standard deviation)
        VEL
    1.82 ± 0.545
    1.70 ± 0.639
    1.79 ± 0.769
    1.79 ± 0.554
    1.88 ± 0.929
        GS-331007
    14.27 ± 2.924
    14.35 ± 2.920
    15.52 ± 4.308
    14.68 ± 3.544
    15.58 ± 4.071
        SOF
    20.64 ± 17.937
    30.78 ± 54.399
    20.87 ± 17.442
    23.33 ± 19.756
    32.88 ± 37.844
        GS-566500
    18.10 ± 5.043
    16.90 ± 4.372
    18.94 ± 5.778
    16.67 ± 4.123
    17.46 ± 6.649
    No statistical analyses for this end point

    Secondary: PK Parameter: Tlast of VEL, GS-331007, SOF, and GS-566500

    		 Close Top of page
    End point title
    		 PK Parameter: Tlast of VEL, GS-331007, SOF, and GS-566500
    End point description
    Tlast is defined as the time (observed time point) of Clast. Participants in the PK Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96 and 120 hours postdose on Days 1 and 10 (all cohorts) and Day 19 (Cohorts 2)
    End point values
    		 Cohort 1, Treatment A Cohort 1, Treatment B Cohort 2, Treatment A Cohort 2, Treatment C Cohort 2, Treatment G
    Number of subjects analysed
    56
    56
    56
    56
    56
    Units: hours
    median (inter-quartile range (Q1-Q3))
        VEL
    96.00 (72.00 to 120.00)
    72.00 (72.00 to 96.00)
    96.00 (72.00 to 120.00)
    96.00 (72.00 to 96.00)
    96.00 (72.00 to 120.00)
        GS-331007
    96.01 (96.00 to 120.00)
    96.00 (96.00 to 108.00)
    96.00 (96.00 to 120.00)
    96.00 (96.00 to 120.00)
    120.00 (120.00 to 120.00)
        SOF
    4.00 (4.00 to 4.00)
    4.00 (4.00 to 4.00)
    4.00 (3.50 to 4.00)
    4.00 (4.00 to 4.00)
    6.00 (5.00 to 8.00)
        GS-566500
    12.00 (12.00 to 12.00)
    12.00 (12.00 to 12.00)
    12.00 (10.00 to 12.00)
    12.00 (12.00 to 12.00)
    16.00 (16.00 to 16.00)
    No statistical analyses for this end point

    Secondary: PK Parameter: t1/2 of VEL, GS-331007, SOF, and GS-566500

    		 Close Top of page
    End point title
    		 PK Parameter: t1/2 of VEL, GS-331007, SOF, and GS-566500
    End point description
    t1/2 is defined as the estimate of the terminal elimination half-life of the drug. Participants in the PK Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96 and 120 hours postdose on Days 1 and 10 (all cohorts) and Day 19 (Cohorts 2)
    End point values
    		 Cohort 1, Treatment A Cohort 1, Treatment B Cohort 2, Treatment A Cohort 2, Treatment C Cohort 2, Treatment G
    Number of subjects analysed
    56
    56
    56
    56
    56
    Units: hours
    median (inter-quartile range (Q1-Q3))
        VEL
    15.47 (13.58 to 19.21)
    15.11 (13.14 to 17.85)
    17.82 (13.11 to 19.98)
    16.54 (13.31 to 19.17)
    17.52 (14.56 to 20.57)
        GS-331007
    27.22 (25.59 to 30.04)
    26.15 (24.33 to 30.15)
    27.82 (24.64 to 31.79)
    26.29 (23.92 to 31.25)
    28.77 (27.00 to 31.14)
        SOF
    0.42 (0.37 to 0.47)
    0.40 (0.36 to 0.45)
    0.44 (0.40 to 0.49)
    0.43 (0.37 to 0.48)
    0.58 (0.49 to 0.67)
        GS-566500
    2.09 (1.99 to 2.16)
    2.07 (1.90 to 2.21)
    2.05 (1.97 to 2.16)
    2.05 (1.92 to 2.20)
    2.33 (2.19 to 2.51)
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information [1]
    Timeframe for reporting adverse events
    Up to Day 19 plus 30 days
    Adverse event reporting additional description
    Safety Analysis Set included all participants who took at least 1 dose of study drug. Participants were grouped according to the treatment they received.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Cohorts 1 and 2, Treatment A
    Reporting group description
    		 Single dose of SOF/VEL (400/100 mg tablet) under fasted conditions

    Reporting group title
    Cohort 1, Treatment B
    Reporting group description
    		 Single dose of SOF/VEL (8 x 50/12.5 mg oral granules; FDC1 - 20% taste-mask coating) under fasted conditions

    Reporting group title
    Cohort 2, Treatment C
    Reporting group description
    		 Single dose of SOF/VEL (8 x 50/12.5 mg oral granules; FDC2 - 5% taste-mask coating) under fasted conditions

    Reporting group title
    Cohort 2, Treatment G
    Reporting group description
    		 Single dose of SOF/VEL (8 x 50/12.5 mg oral granules; FDC2 - 5% taste-mask coating) under fed conditions

    Serious adverse events
    		 Cohorts 1 and 2, Treatment A Cohort 1, Treatment B Cohort 2, Treatment C Cohort 2, Treatment G
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 56 (0.00%)
    0 / 56 (0.00%)
    0 / 56 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Cohorts 1 and 2, Treatment A Cohort 1, Treatment B Cohort 2, Treatment C Cohort 2, Treatment G
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 56 (0.00%)
    0 / 56 (0.00%)
    0 / 56 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: None of the treatment-emergent nonserious AEs occurred in at least 5% of participants of any of the treatment arms.

    More information

    		 Close Top of page

    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
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Fri Apr 26 12:37:25 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA