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    Clinical Trial Results:
    A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered ALS-008176 Regimens in Adult Subjects Hospitalized with Respiratory Syncytial Virus

    Summary
    EudraCT number
    2016-001653-40
    Trial protocol
    GB   BE   ES   PL   SE   NL   BG  
    Global end of trial date
    17 Oct 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    28 Oct 2019
    First version publication date
    28 Oct 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    64041575RSV2003
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02935673
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Janssen Research & Development, LLC
    Sponsor organisation address
    920 Route 202, Raritan, United States, NJ 08869
    Public contact
    Clinical Registry Group, Janssen Research and Development LLC, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen Research and Development LLC, ClinicalTrialsEU@its.jnj.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
    17 Oct 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Oct 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main objectives of this study were to characterize the pharmacokinetics (PK) and to confirm the population PK (popPK) model derived from healthy volunteers in hospitalized adults infected with respiratory syncytial virus (RSV) (Part 1) and to determine in hospitalized adults infected with RSV the dose response relationship of multiple regimens of lumicitabine on antiviral activity based on nasal RSV shedding using quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR) assay (Part 2).
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements. Safety was evaluated throughout the study and included monitoring of adverse events (AEs), clinical laboratory tests, vital signs/peripheral capillary oxygen saturation (SpO2) measurements, physical examinations, and electrocardiograms (ECGs).
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    08 Nov 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 2
    Country: Number of subjects enrolled
    Australia: 7
    Country: Number of subjects enrolled
    Spain: 3
    Country: Number of subjects enrolled
    France: 7
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    Japan: 9
    Country: Number of subjects enrolled
    Korea, Republic of: 4
    Country: Number of subjects enrolled
    Malaysia: 2
    Country: Number of subjects enrolled
    Poland: 2
    Country: Number of subjects enrolled
    Sweden: 7
    Country: Number of subjects enrolled
    Taiwan: 3
    Country: Number of subjects enrolled
    United States: 2
    Worldwide total number of subjects
    49
    EEA total number of subjects
    20
    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)
    20
    From 65 to 84 years
    22
    85 years and over
    7

    Subject disposition

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    Recruitment
    Recruitment details
    Sponsor halted screening and enrollment in study on 22 June 2018 due to emerging lumicitabine nonclinical data. On 17 October 2018, study was stopped prematurely by Sponsor as a precautionary measure, to allow further evaluation of new nonclinical pharmacokinetic (PK) and safety findings and determine their relevance to human studies.

    Pre-assignment
    Screening details
    A total of 49 subjects were randomized and treated (2 subjects in Part 0, 36 subjects in Part 1 and 11 subjects in Part 2). Analyses were conducted on pooled groups across the 3 study parts.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Subjects received a single loading dose (LD) (Dose 1) of matching placebo tablet orally on Day 1 followed by nine maintenance doses (MD) (Doses 2 to 10) of matching placebo tablets orally twice daily (bid) from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received a single LD followed by nine MDs (Doses 2 to 10) of matched placebo bid.

    Arm title
    750 mg LD / 250 mg MD Lumicitabine
    Arm description
    Subjects received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).
    Arm type
    Experimental

    Investigational medicinal product name
    Lumicitabine 250 mg
    Investigational medicinal product code
    Other name
    JNJ-64041575, ALS-008176
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received nine 250 mg MDs (Doses 2 to 10) of lumicitabine bid.

    Investigational medicinal product name
    Lumicitabine 750 mg
    Investigational medicinal product code
    Other name
    JNJ-64041575, ALS-008176
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received a single 750 mg LD of lumicitabine.

    Arm title
    1000 mg LD / 500 mg MD Lumicitabine
    Arm description
    Subjects received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).
    Arm type
    Experimental

    Investigational medicinal product name
    Lumicitabine 1000 mg
    Investigational medicinal product code
    Other name
    JNJ-64041575, ALS-008176
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received a single 1000 mg LD of lumicitabine.

    Investigational medicinal product name
    Lumicitabine 500 mg
    Investigational medicinal product code
    Other name
    JNJ-64041575, ALS-008176
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received nine 500 mg MDs (Doses 2 to 10) of lumicitabine bid.

    Number of subjects in period 1
    Placebo 750 mg LD / 250 mg MD Lumicitabine 1000 mg LD / 500 mg MD Lumicitabine
    Started
    16
    27
    6
    Completed
    15
    24
    6
    Not completed
    1
    3
    0
         Withdrawal by subject
    1
    2
    -
         Adverse event, non-fatal
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subjects received a single loading dose (LD) (Dose 1) of matching placebo tablet orally on Day 1 followed by nine maintenance doses (MD) (Doses 2 to 10) of matching placebo tablets orally twice daily (bid) from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).

    Reporting group title
    750 mg LD / 250 mg MD Lumicitabine
    Reporting group description
    Subjects received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).

    Reporting group title
    1000 mg LD / 500 mg MD Lumicitabine
    Reporting group description
    Subjects received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).

    Reporting group values
    Placebo 750 mg LD / 250 mg MD Lumicitabine 1000 mg LD / 500 mg MD Lumicitabine Total
    Number of subjects
    16 27 6 49
    Title for AgeCategorical
    Units: subjects
        Adults (18-64 years)
    8 10 2 20
        From 65 to 84 years
    5 13 4 22
        85 years and over
    3 4 0 7
    Title for AgeContinuous
    Units: months
        arithmetic mean (standard deviation)
    65.5 ± 17.94 66.3 ± 17.75 68.7 ± 18.46 -
    Title for Gender
    Units: subjects
        Female
    5 9 5 19
        Male
    11 18 1 30

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subjects received a single loading dose (LD) (Dose 1) of matching placebo tablet orally on Day 1 followed by nine maintenance doses (MD) (Doses 2 to 10) of matching placebo tablets orally twice daily (bid) from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).

    Reporting group title
    750 mg LD / 250 mg MD Lumicitabine
    Reporting group description
    Subjects received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).

    Reporting group title
    1000 mg LD / 500 mg MD Lumicitabine
    Reporting group description
    Subjects received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).

    Primary: Maximum Observed Plasma Concentration (Cmax) of JNJ-63549109 at Day 1

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    End point title
    Maximum Observed Plasma Concentration (Cmax) of JNJ-63549109 at Day 1 [1] [2]
    End point description
    Cmax is the maximum observed plasma concentration of JNJ-63549109. JNJ-63549109 is the metabolized product of lumicitabine. Pharmacokinetic (PK) analysis was performed on safety population which included all subjects who received at least 1 dose of study drug, analyzed as treated. Here 'N' (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Analyses were conducted on pooled groups across the 3 study parts.
    End point type
    Primary
    End point timeframe
    Day 1
    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: Descriptive statistics were done, no inferential statistical analyses were performed.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint was planned to be analyzed for specified arm only.
    End point values
    750 mg LD / 250 mg MD Lumicitabine 1000 mg LD / 500 mg MD Lumicitabine
    Number of subjects analysed
    26
    4
    Units: nanogram per milliliter (ng/mL)
        arithmetic mean (standard deviation)
    1845 ± 545.2
    2801 ± 1509
    No statistical analyses for this end point

    Primary: Maximum Observed Plasma Concentration of JNJ-63549109 at Day 5

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    End point title
    Maximum Observed Plasma Concentration of JNJ-63549109 at Day 5 [3] [4]
    End point description
    Cmax is the maximum observed plasma concentration of JNJ-63549109. JNJ-63549109 is the metabolized product of lumicitabine. PK analysis was performed on safety population which included all subjects who received at least 1 dose of study drug, analyzed as treated. Here 'N' (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Analyses were conducted on pooled groups across the 3 study parts.
    End point type
    Primary
    End point timeframe
    Day 5
    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: Descriptive statistics were done, no inferential statistical analyses were performed.
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint was planned to be analyzed for specified arm only.
    End point values
    750 mg LD / 250 mg MD Lumicitabine 1000 mg LD / 500 mg MD Lumicitabine
    Number of subjects analysed
    22
    2
    Units: ng/mL
        arithmetic mean (standard deviation)
    745.4 ± 164.2
    1145 ± 440.8
    No statistical analyses for this end point

    Primary: Area Under the Plasma Concentration-time Curve from Time 0 to 24 Hours After Dosing (AUC[0-24h]) of JNJ-63549109 at Day 1

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    End point title
    Area Under the Plasma Concentration-time Curve from Time 0 to 24 Hours After Dosing (AUC[0-24h]) of JNJ-63549109 at Day 1 [5] [6]
    End point description
    AUC (0-24h) is the area under the plasma concentration-time curve from time 0 to 24 hours after dosing of JNJ-63549109. JNJ-63549109 is the metabolized product of lumicitabine. PK analysis was performed on safety population which included all subjects who received at least 1 dose of study drug, analyzed as treated. Here 'N' (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Analyses were conducted on pooled groups across the 3 study parts.
    End point type
    Primary
    End point timeframe
    Day 1
    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: Descriptive statistics were done, no inferential statistical analyses were performed.
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint was planned to be analyzed for specified arm only.
    End point values
    750 mg LD / 250 mg MD Lumicitabine 1000 mg LD / 500 mg MD Lumicitabine
    Number of subjects analysed
    26
    4
    Units: nanogram*hour per milliliter (ng*h/mL)
        arithmetic mean (standard deviation)
    9936 ± 2090
    17120 ± 4330
    No statistical analyses for this end point

    Primary: Area Under the Plasma Concentration-time Curve from Time 0 to 24 Hours After Dosing (AUC[0-24h]) of JNJ-63549109 at Day 5

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    End point title
    Area Under the Plasma Concentration-time Curve from Time 0 to 24 Hours After Dosing (AUC[0-24h]) of JNJ-63549109 at Day 5 [7] [8]
    End point description
    AUC(0-24h) is the area under the plasma concentration-time curve from time 0 to 24 hours after dosing of JNJ-63549109. JNJ-63549109 is the metabolized product of lumicitabine. PK analysis was performed on safety population which included all subjects who received at least 1 dose of study drug, analyzed as treated. Here 'N' (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Analyses were conducted on pooled groups across the 3 study parts.
    End point type
    Primary
    End point timeframe
    Day 5
    Notes
    [7] - 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: Descriptive statistics were done, no inferential statistical analyses were performed.
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint was planned to be analyzed for specified arm only.
    End point values
    750 mg LD / 250 mg MD Lumicitabine 1000 mg LD / 500 mg MD Lumicitabine
    Number of subjects analysed
    22
    2
    Units: ng*h/mL
        arithmetic mean (standard deviation)
    7557 ± 1525
    13300 ± 4603
    No statistical analyses for this end point

    Primary: Trough Observed Plasma Concentration (Ctrough) of JNJ-63549109 at Day 1

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    End point title
    Trough Observed Plasma Concentration (Ctrough) of JNJ-63549109 at Day 1 [9] [10]
    End point description
    Ctrough is the trough observed plasma concentration of JNJ-63549109. JNJ-63549109 is the metabolized product of lumicitabine. PK analysis was performed on safety population which included all subjects who received at least 1 dose of study drug, analyzed as treated. Here 'N' (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Analyses were conducted on pooled groups across the 3 study parts.
    End point type
    Primary
    End point timeframe
    Day 1
    Notes
    [9] - 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: Descriptive statistics were done, no inferential statistical analyses were performed.
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint was planned to be analyzed for specified arm only.
    End point values
    750 mg LD / 250 mg MD Lumicitabine 1000 mg LD / 500 mg MD Lumicitabine
    Number of subjects analysed
    26
    4
    Units: ng/mL
        arithmetic mean (standard deviation)
    93.7 ± 44.16
    184.4 ± 184.4
    No statistical analyses for this end point

    Primary: Trough Observed Plasma Concentration of JNJ-63549109 at Day 5

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    End point title
    Trough Observed Plasma Concentration of JNJ-63549109 at Day 5 [11] [12]
    End point description
    Ctrough is the trough observed plasma concentration of JNJ-63549109. JNJ-63549109 is the metabolized product of lumicitabine. PK analysis was performed on safety population which included all subjects who received at least 1 dose of study drug, analyzed as treated. Here 'N' (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Analyses were conducted on pooled groups across the 3 study parts.
    End point type
    Primary
    End point timeframe
    Day 5
    Notes
    [11] - 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: Descriptive statistics were done, no inferential statistical analyses were performed.
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint was planned to be analyzed for specified arm only.
    End point values
    750 mg LD / 250 mg MD Lumicitabine 1000 mg LD / 500 mg MD Lumicitabine
    Number of subjects analysed
    22
    2
    Units: ng/mL
        arithmetic mean (standard deviation)
    148.3 ± 60.41
    281.3 ± 156.6
    No statistical analyses for this end point

    Primary: Least Square Mean Difference (Low and High Dose Lumicitabine Versus Placebo) of Respiratory Syncytial Virus (RSV) Ribonucleic Acid (RNA) Viral Load Area Under the Concentration-time Curve From Day 0 to 7 (AUC[0-7])

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    End point title
    Least Square Mean Difference (Low and High Dose Lumicitabine Versus Placebo) of Respiratory Syncytial Virus (RSV) Ribonucleic Acid (RNA) Viral Load Area Under the Concentration-time Curve From Day 0 to 7 (AUC[0-7]) [13] [14]
    End point description
    RSV RNA viral load in log10 copies/milliliter/day (log10 copies/mL/day) was measured in mid-turbinate nasal swabs and in endotracheal samples (obtained from intubated subjects or via suction through tracheostomy or other sampling methods) using quantitative reverse transcription-polymerase chain reaction (qRT-PCR). Intent-to-treat-infected (ITT-i) set included all randomly assigned subjects who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts.
    End point type
    Primary
    End point timeframe
    Day 0 to 7
    Notes
    [13] - 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: Descriptive statistics were done, no inferential statistical analyses were performed.
    [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint was planned to be analyzed for specified arm only.
    End point values
    750 mg LD / 250 mg MD Lumicitabine 1000 mg LD / 500 mg MD Lumicitabine
    Number of subjects analysed
    21
    5
    Units: log10 copies/mL/day
        least squares mean (confidence interval 95%)
    -0.32 (-0.89 to 0.24)
    -0.36 (-1.33 to 0.62)
    No statistical analyses for this end point

    Secondary: Number of Subjects with Adverse Events (AEs)

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    End point title
    Number of Subjects with Adverse Events (AEs)
    End point description
    An AE is any untoward medical occurrence in a clinical study subject administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Safety set included all subjects who received at least 1 dose of study drug, analyzed as treated. Analyses were conducted on pooled groups across the 3 study parts.
    End point type
    Secondary
    End point timeframe
    Up to 28 days
    End point values
    Placebo 750 mg LD / 250 mg MD Lumicitabine 1000 mg LD / 500 mg MD Lumicitabine
    Number of subjects analysed
    16
    27
    6
    Units: Subjects
    7
    22
    5
    No statistical analyses for this end point

    Secondary: Number of Subjects with Vital Sign Abnormalities

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    End point title
    Number of Subjects with Vital Sign Abnormalities
    End point description
    Number of subjects with vital sign (systolic and diastolic blood pressure [BP], pulse rate, respiratory rate, temperature and oxygen saturation) abnormalities were reported. For systolic BP: abnormally low refers to less than or equal to (<=) 90 millimeter of mercury (mmHg); for diastolic BP: abnormally low refers to <=50 mmHg; for pulse rate abnormally low refers to less than (<) 45 beats per minutes (bpm) and abnormally high refers to greater than or equal to (>=) 120 bpm; for temperature in degree Celsius abnormally high refers to greater than (>) 37.8 (tympanic), >38.0 (forehead), >38.0 (oral), >37.2 (rectal), >38.0 (axillary); for oxygen saturation in % abnormally low refers to <95. Grade 1=mild; grade 2=moderate; grade 3=severe. Safety set included all subjects who received at least 1 dose of study drug, analyzed as treated. Here 'n' (number analyzed) signifies number of subjects evaluable for specified categories. Analyses were conducted on pooled groups across 3 study parts.
    End point type
    Secondary
    End point timeframe
    Up to 28 Days
    End point values
    Placebo 750 mg LD / 250 mg MD Lumicitabine 1000 mg LD / 500 mg MD Lumicitabine
    Number of subjects analysed
    16
    27
    6
    Units: Subjects
        Systolic BP (Abnormally Low) (n=16,27,6)
    1
    0
    0
        Systolic BP (Grade 1 or mild) (n=16,27,6)
    2
    6
    2
        Systolic BP (Grade 2 or moderate) (n=16,27,6)
    5
    4
    0
        Systolic BP (Grade 3 or severe) (n=16,27,6)
    1
    1
    1
        Diastolic BP (Abnormally low) (n=16,27,6)
    2
    2
    1
        Diastolic BP (Grade 1 or mild) (n=16,27,6)
    5
    8
    1
        Diastolic BP (Grade 2 or moderate) (n=16,27,6)
    3
    1
    0
        Diastolic BP (Grade 3 or severe) (n=16,27,6)
    0
    1
    0
        Pulse Rate (Abnormally high (n=16,27,6)
    2
    1
    0
        Respiratory Rate (Grade 1 or mild) (n=16,26,6)
    2
    0
    1
        Respiratory Rate (Grade 2 or moderate) (n=16,26,6)
    4
    6
    1
        Respiratory Rate (Grade 3 or severe) (n=16,26,6)
    3
    2
    0
        Temperature (Abnormally high) (n=16,27,6)
    4
    2
    0
        Oxygen Saturation (Abnormally low) (n=16,27,6)
    7
    9
    2
    No statistical analyses for this end point

    Secondary: Number of Subjects with QT Interval Abnormalities

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    End point title
    Number of Subjects with QT Interval Abnormalities
    End point description
    Number of subjects with QT interval abnormalities (prolonged) were reported. Safety set included all subjects who received at least 1 dose of study drug, analyzed as treated. Here 'N' (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Analyses were conducted on pooled groups across the 3 study parts.
    End point type
    Secondary
    End point timeframe
    Up to 28 Days
    End point values
    Placebo 750 mg LD / 250 mg MD Lumicitabine 1000 mg LD / 500 mg MD Lumicitabine
    Number of subjects analysed
    15
    24
    5
    Units: Subjects
    0
    1
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects with Clinical Laboratory Abnormalities

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    End point title
    Number of Subjects with Clinical Laboratory Abnormalities
    End point description
    Number of subjects with clinical laboratory (serum chemistry and hematology) abnormalities were reported. Safety set included all subjects who received at least 1 dose of study drug, analyzed as treated. Here 'n' (number analyzed) signifies number of subjects evaluable for specified categories. Analyses were conducted on pooled groups across the 3 study parts. Abbreviations; Erythrocyte MCHC = Erythrocyte Mean Corpuscular Hemoglobin Concentration; Erythrocyte MCH = Erythrocyte Mean Corpuscular Hemoglobin; Ery. = Erythrocyte
    End point type
    Secondary
    End point timeframe
    Up to 28 Days
    End point values
    Placebo 750 mg LD / 250 mg MD Lumicitabine 1000 mg LD / 500 mg MD Lumicitabine
    Number of subjects analysed
    16
    27
    6
    Units: Subjects
        Bicarbonate : Low (n=9,17,2)
    0
    2
    0
        Bicarbonate: High (n=9,17,2)
    3
    5
    0
        Chloride : Low (n=15,25,6)
    0
    3
    0
        Chloride : High (n=15,25,6)
    0
    2
    0
        Creatine Kinase : Low (n=13,19,6)
    4
    2
    3
        Creatine Kinase ; High (n=13,19,6)
    0
    0
    1
        Direct Bilirubin : High (n=7,15,4)
    0
    1
    0
        Indirect Bilirubin : Low (n=7,12,4)
    1
    0
    2
        Basophils : High (n=16,27,6)
    0
    0
    1
        Eosinophils : High (n=16,27,6)
    3
    1
    1
        Erythrocyte MCHC : Low (n=16,27,6)
    1
    1
    0
        Erythrocyte MCH : Low (n=16,27,6)
    1
    0
    0
        Erythrocyte MCH : High (n=16,27,6)
    0
    3
    1
        Erythrocytes : Low (n=16,27,6)
    5
    3
    1
        Ery. Distribution Width : Low (n=11,20,4)
    0
    1
    0
        Ery. Distribution Width : High (n=11,20,4)
    2
    5
    3
        Hematocrit : Low (n=16,26,6)
    4
    5
    0
        Hematocrit : High (n=16,26,6)
    1
    0
    0
        Lymphocytes : Low (n=16,27,6)
    0
    4
    0
        Lymphocytes : High (n=16,27,6)
    4
    3
    2
        Monocyte : Low (n=16,27,6)
    0
    2
    1
        Monocyte : High (n=16,27,6)
    5
    5
    3
        Reticulocytes : Low (n=8,11,6)
    0
    1
    2
        Reticulocytes : High (n=8,11,6)
    4
    2
    4
        Reticulocytes/Erythrocytes : Low (n=6,14,4)
    1
    0
    1
        Reticulocytes/Erythrocytes : High (n=6,14,4)
    4
    9
    3
    No statistical analyses for this end point

    Secondary: Time of Hospital Stay From Study Treatment Initiation to Discharge

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    End point title
    Time of Hospital Stay From Study Treatment Initiation to Discharge
    End point description
    It is the time from treatment initiation to hospital discharge in hours. ITT-i set included all randomly assigned subjects who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts.
    End point type
    Secondary
    End point timeframe
    From study treatment initiation to discharge (Up to 28 Days)
    End point values
    Placebo 750 mg LD / 250 mg MD Lumicitabine 1000 mg LD / 500 mg MD Lumicitabine
    Number of subjects analysed
    15
    21
    5
    Units: Hours
        arithmetic mean (standard deviation)
    183.91 ± 217.020
    146.72 ± 94.910
    405.24 ± 294.771
    No statistical analyses for this end point

    Secondary: Time of Hospital Stay From Admission to Discharge

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    End point title
    Time of Hospital Stay From Admission to Discharge
    End point description
    It is the time from hospital admission to hospital discharge in hours. ITT-i set included all randomly assigned subjects who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Here 'N' (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Analyses were conducted on pooled groups across the 3 study parts.
    End point type
    Secondary
    End point timeframe
    From admission to discharge (Up to 28 days)
    End point values
    Placebo 750 mg LD / 250 mg MD Lumicitabine 1000 mg LD / 500 mg MD Lumicitabine
    Number of subjects analysed
    10
    17
    3
    Units: Hours
        arithmetic mean (standard deviation)
    192.40 ± 199.363
    181.97 ± 107.938
    297.53 ± 348.729
    No statistical analyses for this end point

    Secondary: Time of Hospital Stay from Study Treatment Initiation to Readiness for Discharge

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    End point title
    Time of Hospital Stay from Study Treatment Initiation to Readiness for Discharge
    End point description
    It is the time from study treatment initiation to readiness for discharge in hours, with readiness for discharge defined by the investigator. ITT-i set included all randomly assigned subjects who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts.
    End point type
    Secondary
    End point timeframe
    From study treatment initiation to readiness for discharge on Day 2 or up to Day 6 if hospitalization is prolonged
    End point values
    Placebo 750 mg LD / 250 mg MD Lumicitabine 1000 mg LD / 500 mg MD Lumicitabine
    Number of subjects analysed
    15
    21
    5
    Units: Hours
        arithmetic mean (standard deviation)
    111.05 ± 78.237
    144.17 ± 96.019
    197.60 ± 256.702
    No statistical analyses for this end point

    Secondary: Time of Hospital Stay from Admission to Readiness for Discharge

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    End point title
    Time of Hospital Stay from Admission to Readiness for Discharge
    End point description
    It is the time from hospital admission to readiness for discharge in hours, with readiness for discharge defined by the investigator. ITT-i set included all randomly assigned subjects who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Here 'N' (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Analyses were conducted on pooled groups across the 3 study parts.
    End point type
    Secondary
    End point timeframe
    Up to 28 Days
    End point values
    Placebo 750 mg LD / 250 mg MD Lumicitabine 1000 mg LD / 500 mg MD Lumicitabine
    Number of subjects analysed
    10
    17
    3
    Units: Hours
        arithmetic mean (standard deviation)
    133.41 ± 83.057
    178.82 ± 108.522
    297.13 ± 349.159
    No statistical analyses for this end point

    Secondary: Number of Subjects Who Required to be Admitted to the Intensive Care Unit (ICU) Since Initiation of Treatment

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    End point title
    Number of Subjects Who Required to be Admitted to the Intensive Care Unit (ICU) Since Initiation of Treatment
    End point description
    Number of subjects who required to be admitted to the ICU after the initiation of treatment were reported. ITT-i set included all randomly assigned subjects who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts.
    End point type
    Secondary
    End point timeframe
    Up to 28 Days
    End point values
    Placebo 750 mg LD / 250 mg MD Lumicitabine 1000 mg LD / 500 mg MD Lumicitabine
    Number of subjects analysed
    15
    21
    5
    Units: Subjects
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Duration of Intensive Care Unit Stay

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    End point title
    Duration of Intensive Care Unit Stay
    End point description
    In the event that a subject required ICU since initiation of treatment, the duration for how long the subject remained in the ICU was measured. ITT-i set included all randomly assigned subjects who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized.
    End point type
    Secondary
    End point timeframe
    Up to 28 Days
    End point values
    Placebo 750 mg LD / 250 mg MD Lumicitabine 1000 mg LD / 500 mg MD Lumicitabine
    Number of subjects analysed
    0 [15]
    0 [16]
    0 [17]
    Units: Hours
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    Notes
    [15] - Overall subjects analyzed is 0 as none of subjects admitted to ICU since initiation of treatment.
    [16] - Overall subjects analyzed is 0 as none of subjects admitted to ICU since initiation of treatment.
    [17] - Overall subjects analyzed is 0 as none of subjects admitted to ICU since initiation of treatment.
    No statistical analyses for this end point

    Secondary: Number of Subjects Who Required Supplemental Oxygen

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    End point title
    Number of Subjects Who Required Supplemental Oxygen
    End point description
    Number of subjects who required supplemental oxygen were reported. ITT-i set included all randomly assigned subjects who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts.
    End point type
    Secondary
    End point timeframe
    Up to 28 Days
    End point values
    Placebo 750 mg LD / 250 mg MD Lumicitabine 1000 mg LD / 500 mg MD Lumicitabine
    Number of subjects analysed
    15
    21
    5
    Units: Subjects
    14
    18
    4
    No statistical analyses for this end point

    Secondary: Time to End of Oxygen Supplementation

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    End point title
    Time to End of Oxygen Supplementation
    End point description
    It is the time from first dose of study drug to the last end date and time of any oxygen supplementation in hours. Population included ITT-i set who required supplemental oxygen. Analyses were conducted on pooled groups across the 3 study parts.
    End point type
    Secondary
    End point timeframe
    Up to 28 Days
    End point values
    Placebo 750 mg LD / 250 mg MD Lumicitabine 1000 mg LD / 500 mg MD Lumicitabine
    Number of subjects analysed
    14
    18
    4
    Units: Hours
        arithmetic mean (standard error)
    83.92 ± 168.125
    139.38 ± 237.584
    132.40 ± 288.568
    No statistical analyses for this end point

    Secondary: Time (Number of Hours) Until Peripheral Capillary Oxygen Saturation (SpO2) Greater Than or Equal to (>=) 93 Percent (%) on Room Air Among Subjects Who Were Not on Supplemental Oxygen Prior to the Onset of Respiratory Symptoms

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    End point title
    Time (Number of Hours) Until Peripheral Capillary Oxygen Saturation (SpO2) Greater Than or Equal to (>=) 93 Percent (%) on Room Air Among Subjects Who Were Not on Supplemental Oxygen Prior to the Onset of Respiratory Symptoms
    End point description
    Time (number of hours) until SpO2 >= 93% on room air among subjects who were not on supplemental oxygen prior to the onset of respiratory symptoms was reported.
    End point type
    Secondary
    End point timeframe
    Up to 28 Days
    End point values
    Placebo 750 mg LD / 250 mg MD Lumicitabine 1000 mg LD / 500 mg MD Lumicitabine
    Number of subjects analysed
    0 [18]
    0 [19]
    0 [20]
    Units: Hours
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    Notes
    [18] - Data was not collected and analyzed because this study was stopped prematurely.
    [19] - Data was not collected and analyzed because this study was stopped prematurely.
    [20] - Data was not collected and analyzed because this study was stopped prematurely.
    No statistical analyses for this end point

    Secondary: Time to Return to Pre-respiratory Syncytial Virus (Pre-RSV) Disease Level for Respiratory Rate

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    End point title
    Time to Return to Pre-respiratory Syncytial Virus (Pre-RSV) Disease Level for Respiratory Rate
    End point description
    It is the time from first dose of study drug until the time to return to pre-RSV disease level for respiratory rate. The return to pre-RSV disease level occurred when the observed value of the parameter was indicated by the investigator as normal, and no later observed values were indicated by the investigator as abnormal. ITT-i set included all randomly assigned subjects who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts.
    End point type
    Secondary
    End point timeframe
    Up to 28 Days
    End point values
    Placebo 750 mg LD / 250 mg MD Lumicitabine 1000 mg LD / 500 mg MD Lumicitabine
    Number of subjects analysed
    15
    21
    5
    Units: Hours
        arithmetic mean (standard deviation)
    64.72 ± 180.542
    47.75 ± 153.293
    196.96 ± 290.694
    No statistical analyses for this end point

    Secondary: Time to Return to Pre-RSV Disease Level for Oxygen Saturation

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    End point title
    Time to Return to Pre-RSV Disease Level for Oxygen Saturation
    End point description
    It is the time from first dose of study drug until the time to return to pre-RSV disease level for oxygen saturation. The return to pre-RSV disease level occurred when the observed value of the parameter was indicated by the investigator as normal, and no later observed values were indicated by the investigator as abnormal. ITT-i set included all randomly assigned subjects who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts.
    End point type
    Secondary
    End point timeframe
    Up to 28 Days
    End point values
    Placebo 750 mg LD / 250 mg MD Lumicitabine 1000 mg LD / 500 mg MD Lumicitabine
    Number of subjects analysed
    15
    21
    5
    Units: Hours
        arithmetic mean (standard deviation)
    55.55 ± 85.915
    33.85 ± 57.703
    47.56 ± 106.347
    No statistical analyses for this end point

    Secondary: Time to Return to Pre-RSV Disease Level for Body Temperature

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    End point title
    Time to Return to Pre-RSV Disease Level for Body Temperature
    End point description
    It is the time from first dose of study drug until the time to return to pre-RSV disease level for body temperature. The return to pre-RSV disease level occurred when the observed value of the parameter was indicated by the investigator as normal, and no later observed values were indicated by the investigator as abnormal.
    End point type
    Secondary
    End point timeframe
    Up to 28 Days
    End point values
    Placebo 750 mg LD / 250 mg MD Lumicitabine 1000 mg LD / 500 mg MD Lumicitabine
    Number of subjects analysed
    0 [21]
    0 [22]
    0 [23]
    Units: Degree Celsius
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    Notes
    [21] - Data was not collected and analyzed because this study was stopped prematurely.
    [22] - Data was not collected and analyzed because this study was stopped prematurely.
    [23] - Data was not collected and analyzed because this study was stopped prematurely.
    No statistical analyses for this end point

    Secondary: Number of Subjects Who Required Noninvasive Mechanical Ventilation Support

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    End point title
    Number of Subjects Who Required Noninvasive Mechanical Ventilation Support
    End point description
    Number of subjects who required noninvasive mechanical ventilation support (that is supplemental oxygen [excluding mechanical ventilation]) were reported. ITT-i set included all randomly assigned subjects who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts.
    End point type
    Secondary
    End point timeframe
    Up to 28 Days
    End point values
    Placebo 750 mg LD / 250 mg MD Lumicitabine 1000 mg LD / 500 mg MD Lumicitabine
    Number of subjects analysed
    15
    21
    5
    Units: Subjects
    14
    18
    4
    No statistical analyses for this end point

    Secondary: Time to End of Noninvasive Mechanical Ventilation Support

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    End point title
    Time to End of Noninvasive Mechanical Ventilation Support
    End point description
    It is the time from first dose of study drug to the last end date and time of noninvasive mechanical ventilation in hours. Population included ITT-i set who required noninvasive mechanical ventilation support. Analyses were conducted on pooled groups across the 3 study parts.
    End point type
    Secondary
    End point timeframe
    Up to 28 Days
    End point values
    Placebo 750 mg LD / 250 mg MD Lumicitabine 1000 mg LD / 500 mg MD Lumicitabine
    Number of subjects analysed
    14
    18
    4
    Units: Hours
        arithmetic mean (standard deviation)
    83.92 ± 168.125
    139.38 ± 237.584
    132.40 ± 288.568
    No statistical analyses for this end point

    Secondary: Number of Subjects Who Required Invasive Mechanical Ventilation Support

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    End point title
    Number of Subjects Who Required Invasive Mechanical Ventilation Support
    End point description
    Number of subjects who required invasive mechanical ventilation support were reported. ITT-i set included all randomly assigned subjects who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts.
    End point type
    Secondary
    End point timeframe
    Up to 28 Days
    End point values
    Placebo 750 mg LD / 250 mg MD Lumicitabine 1000 mg LD / 500 mg MD Lumicitabine
    Number of subjects analysed
    15
    21
    5
    Units: Subjects
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Time to End of Invasive Mechanical Ventilation Support

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    End point title
    Time to End of Invasive Mechanical Ventilation Support
    End point description
    It is the time from first dose of study drug to the last end date and time of invasive mechanical ventilation support in hours. ITT-i set included all randomly assigned subjects who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Zero subjects were analysed for this endpoint as none of subjects required invasive ventilation support. Analyses were conducted on pooled groups across the 3 study parts.
    End point type
    Secondary
    End point timeframe
    Up to 28 Days
    End point values
    Placebo 750 mg LD / 250 mg MD Lumicitabine 1000 mg LD / 500 mg MD Lumicitabine
    Number of subjects analysed
    0 [24]
    0 [25]
    0 [26]
    Units: Hours
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    Notes
    [24] - 0 subjects analysed for this endpoint as none of subjects required invasive ventilation support.
    [25] - 0 subjects analysed for this endpoint as none of subjects required invasive ventilation support.
    [26] - 0 subjects analysed for this endpoint as none of subjects required invasive ventilation support.
    No statistical analyses for this end point

    Secondary: Time to Return to Pre-RSV Functional Status as Assessed by KATZ Activities of Daily Living (ADL) Score

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    End point title
    Time to Return to Pre-RSV Functional Status as Assessed by KATZ Activities of Daily Living (ADL) Score
    End point description
    It is the time from first dose of study drug until the time to return to pre-RSV functional status. Functional status is total points on KATZ index of independence in activities of daily living (KATZ ADL score). Katz activities of daily living assessed questions related to bathing, dressing, toileting, transferring, continence and feeding components. Total score was calculated by adding scores for all 6 activities which ranges from 0 high (subject independent) to 6 low (subject very dependent). Return to pre-RSV functional status occurs at timepoint where for first time KATZ ADL score is equal or higher than pre-RSV KATZ ADL score and after which no scores lower than pre-RSV KATZ ADL score occur anymore. ITT-i set included all randomly assigned subjects who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts.
    End point type
    Secondary
    End point timeframe
    Up to 28 Days
    End point values
    Placebo 750 mg LD / 250 mg MD Lumicitabine 1000 mg LD / 500 mg MD Lumicitabine
    Number of subjects analysed
    15
    21
    5
    Units: Days
        arithmetic mean (standard deviation)
    3.60 ± 7.434
    4.48 ± 6.961
    6.00 ± 11.203
    No statistical analyses for this end point

    Secondary: Number of Subjects Who Required Hydration or Feeding by Intravenous (IV) Catheter or Nasogastric Tube

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    End point title
    Number of Subjects Who Required Hydration or Feeding by Intravenous (IV) Catheter or Nasogastric Tube
    End point description
    Number of subjects who required hydration or feeding by IV catheter or nasogastric tube were reported. ITT-i set included all randomly assigned subjects who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts.
    End point type
    Secondary
    End point timeframe
    Up to 28 Days
    End point values
    Placebo 750 mg LD / 250 mg MD Lumicitabine 1000 mg LD / 500 mg MD Lumicitabine
    Number of subjects analysed
    15
    21
    5
    Units: Subjects
    3
    5
    1
    No statistical analyses for this end point

    Secondary: Time to Clinical Stability

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    End point title
    Time to Clinical Stability
    End point description
    Time to clinical stability is defined as the time from first dose of study drug until the time at which the following criteria were all met: normalization of blood oxygen level (return to baseline; by pulse oximetry) without requirement of supplemental oxygen beyond baseline level, normalization of oral feeding, normalization of respiratory rate and normalization of heart rate. ITT-i set included all randomly assigned subjects who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts.
    End point type
    Secondary
    End point timeframe
    Up to 28 Days
    End point values
    Placebo 750 mg LD / 250 mg MD Lumicitabine 1000 mg LD / 500 mg MD Lumicitabine
    Number of subjects analysed
    15
    21
    5
    Units: Hours
        arithmetic mean (standard deviation)
    151.21 ± 266.460
    171.74 ± 261.384
    207.00 ± 282.955
    No statistical analyses for this end point

    Secondary: Number of Subjects in Each Ordinal Scale Category

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    End point title
    Number of Subjects in Each Ordinal Scale Category
    End point description
    Number of subjects in each ordinal scale category were reported. Ordinal scale consists of 6 categories or clinical states that are exhaustive, mutually exclusive, and ordered: category 1) death; category 2) admitted to ICU; category 3) non-ICU hospitalization requiring supplemental oxygen; category 4) non-ICU hospitalization not requiring supplemental oxygen; category 5) not hospitalized, unable to resume normal activities; category 6) not hospitalized, resumption of normal activities. ITT-i set included all randomly assigned subjects who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts.
    End point type
    Secondary
    End point timeframe
    Day 5/6 (Day of last study treatment)
    End point values
    Placebo 750 mg LD / 250 mg MD Lumicitabine 1000 mg LD / 500 mg MD Lumicitabine
    Number of subjects analysed
    15
    21
    5
    Units: Subjects
        Category 1
    0
    0
    0
        Category 2
    0
    1
    0
        Category 3
    2
    5
    1
        Category 4
    6
    8
    1
        Category 5
    5
    2
    1
        Category 6
    2
    5
    2
    No statistical analyses for this end point

    Secondary: Number of Subjects with All-Cause Mortality

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    End point title
    Number of Subjects with All-Cause Mortality
    End point description
    All-cause mortality included all deaths of subjects due to any cause. Safety set included all subjects who received at least 1 dose of study drug, analyzed as treated. Analyses were conducted on pooled groups across the 3 study parts.
    End point type
    Secondary
    End point timeframe
    Up to 28 Days
    End point values
    Placebo 750 mg LD / 250 mg MD Lumicitabine 1000 mg LD / 500 mg MD Lumicitabine
    Number of subjects analysed
    16
    27
    6
    Units: Subjects
    0
    0
    0
    No statistical analyses for this end point

    Secondary: RSV RNA Viral Load Over Time

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    End point title
    RSV RNA Viral Load Over Time
    End point description
    Antiviral activity RSV RNA viral load was measured in mid-turbinate nasal swabs (obtained from non-intubated subjects) or in mid-turbinate nasal swabs and endotracheal samples (obtained from intubated subjects or via suction through tracheostomy or other sampling methods) using qRT-PCR performed at the central laboratory. ITT-i set included all randomly assigned subjects who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Here 'n' (number analyzed) signifies number of subjects evaluable for each time point. Analyses were conducted on pooled groups across the 3 study parts.
    End point type
    Secondary
    End point timeframe
    Days 2, 3, 4, 5, 6, 7, 10, 14 and 28
    End point values
    Placebo 750 mg LD / 250 mg MD Lumicitabine 1000 mg LD / 500 mg MD Lumicitabine
    Number of subjects analysed
    15
    21
    5
    Units: log10 copies/mL
    arithmetic mean (standard deviation)
        Day 2 (n=15,21,4)
    5.9257 ± 1.95951
    4.7208 ± 1.60154
    3.4242 ± 1.10867
        Day 3 (n=15,19,3)
    4.8255 ± 1.84651
    4.3515 ± 1.97633
    4.3129 ± 0.99078
        Day 4 (n=15,21,3)
    4.0608 ± 1.57493
    3.9345 ± 1.64600
    4.0729 ± 1.15419
        Day 5 (n=15,20,3)
    3.6463 ± 1.44056
    3.6206 ± 1.71515
    4.5344 ± 0.97473
        Day 6 (n=15,19,3)
    3.6996 ± 1.98383
    3.4313 ± 1.57700
    3.2163 ± 1.30083
        Day 7 (n=15,19,5)
    3.4044 ± 1.75773
    3.2306 ± 1.58432
    2.6147 ± 0.89779
        Day 10 (n=15,15,4)
    2.5966 ± 1.04644
    2.7516 ± 1.72825
    2.5792 ± 1.00954
        Day 14 (n=15,21,4)
    2.3605 ± 1.00220
    2.3010 ± 1.03732
    2.1512 ± 0.50236
        Day 28 (n=14,21,4)
    1.9179 ± 0.06682
    1.9714 ± 0.22559
    1.9000 ± 0.00000
    No statistical analyses for this end point

    Secondary: Peak Viral Load

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    End point title
    Peak Viral Load
    End point description
    Peak Viral load is the highest value of log10 viral load at or after the baseline measurement. Peak viral load over time was measured by qRT-PCR.
    End point type
    Secondary
    End point timeframe
    Up to 28 Days
    End point values
    Placebo 750 mg LD / 250 mg MD Lumicitabine 1000 mg LD / 500 mg MD Lumicitabine
    Number of subjects analysed
    0 [27]
    0 [28]
    0 [29]
    Units: Copies/mL
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    Notes
    [27] - Data was not collected and analyzed because this study was stopped prematurely.
    [28] - Data was not collected and analyzed because this study was stopped prematurely.
    [29] - Data was not collected and analyzed because this study was stopped prematurely.
    No statistical analyses for this end point

    Secondary: Time to Peak Viral Load

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    End point title
    Time to Peak Viral Load
    End point description
    Time to peak viral load is the time from initiation of study treatment until the first time point with the peak viral load.
    End point type
    Secondary
    End point timeframe
    Up to 28 Days
    End point values
    Placebo 750 mg LD / 250 mg MD Lumicitabine 1000 mg LD / 500 mg MD Lumicitabine
    Number of subjects analysed
    0 [30]
    0 [31]
    0 [32]
    Units: Hours
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    Notes
    [30] - Data was not collected and analyzed because this study was stopped prematurely.
    [31] - Data was not collected and analyzed because this study was stopped prematurely.
    [32] - Data was not collected and analyzed because this study was stopped prematurely.
    No statistical analyses for this end point

    Secondary: Rate of Decline of Viral Load

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    End point title
    Rate of Decline of Viral Load
    End point description
    Rate of decline of viral load over the first 24 hours calculated as a log decline/24 hours defined as: 24-hour log viral load after first dose of study drug minus (–) log viral load at baseline divided by (/) date/time of 24-hour viral load sample – date/time of baseline viral load.
    End point type
    Secondary
    End point timeframe
    Up to 28 Days
    End point values
    Placebo 750 mg LD / 250 mg MD Lumicitabine 1000 mg LD / 500 mg MD Lumicitabine
    Number of subjects analysed
    0 [33]
    0 [34]
    0 [35]
    Units: copies/ml
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    Notes
    [33] - Data was not collected and analyzed because this study was stopped prematurely.
    [34] - Data was not collected and analyzed because this study was stopped prematurely.
    [35] - Data was not collected and analyzed because this study was stopped prematurely.
    No statistical analyses for this end point

    Secondary: Time to RSV RNA Viral Load Being Undetectable

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    End point title
    Time to RSV RNA Viral Load Being Undetectable
    End point description
    It is the time in hours from initiation of study treatment until the first post baseline time point at which the virus is undetectable in an assessment and after which time no detectable virus assessment follows as measured by qRT-PCR.
    End point type
    Secondary
    End point timeframe
    Up to 28 Days
    End point values
    Placebo 750 mg LD / 250 mg MD Lumicitabine 1000 mg LD / 500 mg MD Lumicitabine
    Number of subjects analysed
    0 [36]
    0 [37]
    0 [38]
    Units: Hours
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    Notes
    [36] - Data was not collected and analyzed because this study was stopped prematurely.
    [37] - Data was not collected and analyzed because this study was stopped prematurely.
    [38] - Data was not collected and analyzed because this study was stopped prematurely.
    No statistical analyses for this end point

    Secondary: Number of Subjects with Undetectable Viral Load

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    End point title
    Number of Subjects with Undetectable Viral Load
    End point description
    Number of subjects with undetectable viral load up to 28 days were reported. ITT-i set included all randomly assigned subjects who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts.
    End point type
    Secondary
    End point timeframe
    Up to 28 Days
    End point values
    Placebo 750 mg LD / 250 mg MD Lumicitabine 1000 mg LD / 500 mg MD Lumicitabine
    Number of subjects analysed
    15
    21
    5
    Units: Subjects
    14
    19
    5
    No statistical analyses for this end point

    Secondary: RSV RNA Viral Load AUC up to Day 14

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    End point title
    RSV RNA Viral Load AUC up to Day 14
    End point description
    RSV RNA viral load was measured in midturbinate nasal swabs and in endotracheal samples (obtained from intubated subjects or via suction through tracheostomy or other sampling.
    End point type
    Secondary
    End point timeframe
    Up to Day 14
    End point values
    Placebo 750 mg LD / 250 mg MD Lumicitabine 1000 mg LD / 500 mg MD Lumicitabine
    Number of subjects analysed
    0 [39]
    0 [40]
    0 [41]
    Units: Log10 copies/mL/day
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    Notes
    [39] - Data was not collected and analyzed because this study was stopped prematurely.
    [40] - Data was not collected and analyzed because this study was stopped prematurely.
    [41] - Data was not collected and analyzed because this study was stopped prematurely.
    No statistical analyses for this end point

    Secondary: RSV RNA Viral Load AUC in Subjects Assigned to a Longer Dosing Duration

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    End point title
    RSV RNA Viral Load AUC in Subjects Assigned to a Longer Dosing Duration
    End point description
    RSV RNA viral load was measured in midturbinate nasal swabs and in endotracheal samples (obtained from intubated subjects or via suction through tracheostomy or other sampling. ITT-i set included all randomly assigned subjects who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized.
    End point type
    Secondary
    End point timeframe
    Up to 1 Day after the last dose of study drug
    End point values
    Placebo 750 mg LD / 250 mg MD Lumicitabine 1000 mg LD / 500 mg MD Lumicitabine
    Number of subjects analysed
    0 [42]
    0 [43]
    0 [44]
    Units: log10 copies/mL/day
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    Notes
    [42] - No subject received extended treatment, therefore data was not analyzed.
    [43] - No subject received extended treatment, therefore data was not analyzed.
    [44] - No subject received extended treatment, therefore data was not analyzed.
    No statistical analyses for this end point

    Secondary: Number of Subjects with Postbaseline Changes in the RSV Polymerase L Gene and Other Regions of the RSV Genome Compared with Baseline Sequences

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    End point title
    Number of Subjects with Postbaseline Changes in the RSV Polymerase L Gene and Other Regions of the RSV Genome Compared with Baseline Sequences
    End point description
    Number of subjects with postbaseline changes in the RSV polymerase L gene and other regions of the RSV genome compared with baseline sequences were reported. ITT-i set included all randomly assigned subjects who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Here 'N' (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Analyses were conducted on pooled groups across the 3 study parts.
    End point type
    Secondary
    End point timeframe
    Baseline up to 28 Days
    End point values
    Placebo 750 mg LD / 250 mg MD Lumicitabine 1000 mg LD / 500 mg MD Lumicitabine
    Number of subjects analysed
    10
    12
    4
    Units: Subjects
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 28 Days
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subjects received a single loading dose (LD) (Dose 1) of matching placebo tablet orally on Day 1 followed by nine maintenance doses (MD) (Doses 2 to 10) of matching placebo tablets orally twice daily (bid) from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).

    Reporting group title
    750 mg LD / 250 mg MD Lumicitabine
    Reporting group description
    Subjects received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).

    Reporting group title
    1000 mg LD / 500 mg MD Lumicitabine
    Reporting group description
    Subjects received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration).

    Serious adverse events
    Placebo 750 mg LD / 250 mg MD Lumicitabine 1000 mg LD / 500 mg MD Lumicitabine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 16 (12.50%)
    4 / 27 (14.81%)
    1 / 6 (16.67%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Thermal Burn
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 27 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac Failure
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 27 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic Obstructive Pulmonary Disease
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 27 (3.70%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Pancytopenia
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 27 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Intestinal Obstruction
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 27 (3.70%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 27 (3.70%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Influenza
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 27 (3.70%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 27 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Placebo 750 mg LD / 250 mg MD Lumicitabine 1000 mg LD / 500 mg MD Lumicitabine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 16 (37.50%)
    17 / 27 (62.96%)
    5 / 6 (83.33%)
    Vascular disorders
    Deep Vein Thrombosis
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 27 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Hypertension
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 27 (3.70%)
    0 / 6 (0.00%)
         occurrences all number
    4
    1
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 27 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Chest Pain
         subjects affected / exposed
    2 / 16 (12.50%)
    2 / 27 (7.41%)
    0 / 6 (0.00%)
         occurrences all number
    3
    2
    0
    Oedema Peripheral
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 27 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Pyrexia
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 27 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    2 / 16 (12.50%)
    0 / 27 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    0
    Injury, poisoning and procedural complications
    Overdose
         subjects affected / exposed
    1 / 16 (6.25%)
    3 / 27 (11.11%)
    0 / 6 (0.00%)
         occurrences all number
    1
    3
    0
    Investigations
    Alanine Aminotransferase Increased
         subjects affected / exposed
    1 / 16 (6.25%)
    2 / 27 (7.41%)
    1 / 6 (16.67%)
         occurrences all number
    1
    2
    1
    Aspartate Aminotransferase Increased
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 27 (3.70%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    1
    Blood Creatine Phosphokinase Increased
         subjects affected / exposed
    0 / 16 (0.00%)
    2 / 27 (7.41%)
    0 / 6 (0.00%)
         occurrences all number
    0
    2
    0
    Blood Fibrinogen Increased
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 27 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    C-Reactive Protein Increased
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 27 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Eosinophil Count Increased
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 27 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Gamma-Glutamyltransferase Increased
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 27 (3.70%)
    0 / 6 (0.00%)
         occurrences all number
    1
    1
    0
    Hepatic Enzyme Increased
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 27 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Occult Blood Positive
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 27 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Blood and lymphatic system disorders
    Eosinophilia
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 27 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Febrile Neutropenia
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 27 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 16 (0.00%)
    2 / 27 (7.41%)
    0 / 6 (0.00%)
         occurrences all number
    0
    2
    0
    Chronic Obstructive Pulmonary Disease
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 27 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Haemoptysis
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 27 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    2
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 27 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Headache
         subjects affected / exposed
    0 / 16 (0.00%)
    2 / 27 (7.41%)
    0 / 6 (0.00%)
         occurrences all number
    0
    2
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 27 (3.70%)
    0 / 6 (0.00%)
         occurrences all number
    1
    1
    0
    Abdominal Pain Upper
         subjects affected / exposed
    0 / 16 (0.00%)
    2 / 27 (7.41%)
    1 / 6 (16.67%)
         occurrences all number
    0
    2
    1
    Gastritis
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 27 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Hepatobiliary disorders
    Hepatic Function Abnormal
         subjects affected / exposed
    0 / 16 (0.00%)
    2 / 27 (7.41%)
    0 / 6 (0.00%)
         occurrences all number
    0
    2
    0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 27 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Renal Impairment
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 27 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 27 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Erythema
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 27 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Alopecia
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 27 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Haemorrhage Subcutaneous
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 27 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Hyperhidrosis
         subjects affected / exposed
    0 / 16 (0.00%)
    2 / 27 (7.41%)
    0 / 6 (0.00%)
         occurrences all number
    0
    2
    0
    Rash
         subjects affected / exposed
    1 / 16 (6.25%)
    3 / 27 (11.11%)
    1 / 6 (16.67%)
         occurrences all number
    1
    3
    1
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    0 / 16 (0.00%)
    2 / 27 (7.41%)
    0 / 6 (0.00%)
         occurrences all number
    0
    2
    0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 27 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    0
    Infections and infestations
    Respiratory Tract Infection Bacterial
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 27 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Acarodermatitis
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 27 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Urinary Tract Infection
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 27 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Jul 2016
    The overall reason for the amendment 1 was to add an inclusion criteria for female subjects to assure that woman agree not to donate eggs, and to add a section on rash management.
    13 Jan 2017
    The overall reason for the amendment 2 was to create a new Part 1 of the study protocol to characterize the pharmacokinetics (PK), to confirm the population pharmacokinetic (popPK) model derived from healthy volunteers in hospitalized adults with respiratory syncytial virus (RSV) infection, and to more clearly define the study eligibility criteria to ensure subject safety. Furthermore, changes requested by health authorities were made: women of childbearing potential were allowed to participate in the study, the age limit for subjects was lowered, the endpoints of the study were updated, subjects on extracorporeal membrane oxygenation were excluded, the guidelines concerning corticosteroid use were adjusted, clarifications regarding the use of the electronic clinical outcome assessment (eCOA) device were added single electrocardiogram (ECG) measurements were changed to triplicate ECGs and the dose dispensing instructions were deleted.
    05 Sep 2017
    The overall reason for the amendment 3 was to remove furosemide, ibuprofen, and trimethoprim/sulfametoxazole from the list of prohibited moderate/strong inhibitors of organic anion transporter (OAT) 3.
    20 Mar 2018
    The overall reason for the amendment 4 was for Part 2 of the study (1) to include additional safety samples for biochemistry, (2) to lift the requirement for triplicate electrocardiograms (ECGs) and reduce the ECG timepoints, (3) to prohibit the use of P-glycoprotein (P-gp) inhibitors and inducers, and (4) to optimize the PK sampling scheme.

    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.
    As the study was stopped prematurely the planned final analyses were adapted. Due to small number of subjects in Part 2, it was decided to pool the data from the 3 parts of the study to perform an evaluation of selected planned analyses only.
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