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    Clinical Trial Results:
    A Single-dose, Open-label, Randomized, Crossover Pivotal Bioequivalence Study in Healthy Participants to Assess the Bioequivalence of Darunavir 600 mg in the Presence of Cobicistat 90 mg When Administered as a Fixed Dose Combination Tablet (Darunavir/Cobicistat) Compared to the Co-administration of the Separate Available Formulations (Darunavir 100 mg/mL Suspension at a Dose of 600 mg and Cobicistat 90 mg tablet), Under Fed Conditions

    Summary
    EudraCT number
    2021-003955-40
    Trial protocol
    BE  
    Global end of trial date
    28 Sep 2022

    Results information
    Results version number
    v1(current)
    This version publication date
    07 Oct 2023
    First version publication date
    07 Oct 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TMC114FD1HTX1004
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT05378906
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Janssen-Cilag International N.V.
    Sponsor organisation address
    Turnhoutseweg 30, Beerse, Belgium, B-2340
    Public contact
    Clinical Registry Group, Janssen-Cilag International N.V., ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen-Cilag International N.V., ClinicalTrialsEU@its.jnj.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-001280-PIP01-12
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    28 Sep 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Sep 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study was to evaluate the single-dose pharmacokinetic (PK) and bioequivalence of darunavir (DRV) 600 milligrams (mg) in the presence of cobicistat (COBI) 90 mg when administered as a fixed dose combination (FDC) tablet dispersed in water (DRV/COBI 600/90 mg) compared to the coadministration of the separate available formulations (DRV 100 milligram per millilitre [mg/mL] suspension at a dose of 600 mg and COBI 1*90 mg tablet), under fed conditions in healthy subjects.
    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.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    07 Jun 2022
    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
    Belgium: 32
    Worldwide total number of subjects
    32
    EEA total number of subjects
    32
    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)
    32
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    A total of 32 healthy subjects were randomised and treated (16 subjects in each treatment sequence AB and treatment sequence BA).

    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 Sequence AB
    Arm description
    Subjects received a single oral dose of Darunavir (DRV) (600 milligrams [mg]) and Cobicistat (COBI) (90 mg) as one fixed dose combination (FDC) tablet under fed conditions (Treatment A, test) on Day 1 of Period 1 followed by a single oral dose of DRV 600 mg as 100 milligram per millilitre (mg/mL) suspension and COBI 90 mg tablet under fed conditions (Treatment B, reference) on Day 1 of Period 2. Each period was separated by a washout period of at least 7 days.
    Arm type
    Experimental

    Investigational medicinal product name
    Darunavir 100 mg/mL suspension
    Investigational medicinal product code
    Other name
    TMC114
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received a single dose of Darunavir 600mg as 100 mg/mL suspension orally as Treatment B on Day 1 as per assigned treatment sequences.

    Investigational medicinal product name
    Cobicistat 90 mg
    Investigational medicinal product code
    Other name
    JNJ-48763364
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received a single dose of Cobicistat 90 mg tablet orally as a component of Treatment B on Day 1 as per assigned treatment sequences.

    Investigational medicinal product name
    Darunavir 600 mg and Cobicistat 90 mg as one FDC tablet
    Investigational medicinal product code
    Other name
    TMC114/JNJ-48763364
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received a single dose of Darunavir 600 mg and Cobicistat 90 mg FDC tablet orally as Treatment A on Day 1 as per assigned treatment sequences.

    Arm title
    Treatment Sequence BA
    Arm description
    Subjects received a single oral dose of DRV 600 mg as 100 mg/mL suspension and COBI 90 mg tablet under fed conditions (Treatment B, reference) on Day 1 of Period 1 followed by a single oral dose of DRV (600 mg) and COBI (90 mg) as one FDC tablet under fed conditions (Treatment A, test) on Day 1 of Period 2. Each period was separated by a washout period of at least 7 days.
    Arm type
    Experimental

    Investigational medicinal product name
    Darunavir 100 mg/mL suspension
    Investigational medicinal product code
    Other name
    TMC114
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received a single dose of Darunavir 600mg as 100 mg/mL suspension orally as Treatment B on Day 1 as per assigned treatment sequences.

    Investigational medicinal product name
    Darunavir 600 mg and Cobicistat 90 mg as one FDC tablet
    Investigational medicinal product code
    Other name
    TMC114/JNJ-48763364
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received a single dose of Darunavir 600 mg and Cobicistat 90 mg FDC tablet orally as Treatment A on Day 1 as per assigned treatment sequences.

    Investigational medicinal product name
    Cobicistat 90 mg
    Investigational medicinal product code
    Other name
    JNJ-48763364
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received a single dose of Cobicistat 90 mg tablet orally as a component of Treatment B on Day 1 as per assigned treatment sequences.

    Number of subjects in period 1
    Treatment Sequence AB Treatment Sequence BA
    Started
    16
    16
    Treatment A
    16
    16
    Treatment B
    14
    16
    Completed
    14
    16
    Not completed
    2
    0
         Covid-19
    1
    -
         Withdrawal by subject
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment Sequence AB
    Reporting group description
    Subjects received a single oral dose of Darunavir (DRV) (600 milligrams [mg]) and Cobicistat (COBI) (90 mg) as one fixed dose combination (FDC) tablet under fed conditions (Treatment A, test) on Day 1 of Period 1 followed by a single oral dose of DRV 600 mg as 100 milligram per millilitre (mg/mL) suspension and COBI 90 mg tablet under fed conditions (Treatment B, reference) on Day 1 of Period 2. Each period was separated by a washout period of at least 7 days.

    Reporting group title
    Treatment Sequence BA
    Reporting group description
    Subjects received a single oral dose of DRV 600 mg as 100 mg/mL suspension and COBI 90 mg tablet under fed conditions (Treatment B, reference) on Day 1 of Period 1 followed by a single oral dose of DRV (600 mg) and COBI (90 mg) as one FDC tablet under fed conditions (Treatment A, test) on Day 1 of Period 2. Each period was separated by a washout period of at least 7 days.

    Reporting group values
    Treatment Sequence AB Treatment Sequence BA Total
    Number of subjects
    16 16 32
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    16 16 32
        From 65 to 84 years
    0 0 0
        85 years and over
    0 0 0
    Title for AgeContinuous
    Units: years
        median (full range (min-max))
    39 (21 to 54) 41 (18 to 55) -
    Title for Gender
    Units: subjects
        Female
    9 9 18
        Male
    7 7 14

    End points

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    End points reporting groups
    Reporting group title
    Treatment Sequence AB
    Reporting group description
    Subjects received a single oral dose of Darunavir (DRV) (600 milligrams [mg]) and Cobicistat (COBI) (90 mg) as one fixed dose combination (FDC) tablet under fed conditions (Treatment A, test) on Day 1 of Period 1 followed by a single oral dose of DRV 600 mg as 100 milligram per millilitre (mg/mL) suspension and COBI 90 mg tablet under fed conditions (Treatment B, reference) on Day 1 of Period 2. Each period was separated by a washout period of at least 7 days.

    Reporting group title
    Treatment Sequence BA
    Reporting group description
    Subjects received a single oral dose of DRV 600 mg as 100 mg/mL suspension and COBI 90 mg tablet under fed conditions (Treatment B, reference) on Day 1 of Period 1 followed by a single oral dose of DRV (600 mg) and COBI (90 mg) as one FDC tablet under fed conditions (Treatment A, test) on Day 1 of Period 2. Each period was separated by a washout period of at least 7 days.

    Subject analysis set title
    Treatment A
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects received a single oral dose of Darunavir (DRV) (600 milligrams [mg]) and Cobicistat (COBI) (90 mg) as one fixed dose combination (FDC) tablet under fed conditions on Day 1 of each treatment period.

    Subject analysis set title
    Treatment B
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects received a single oral dose of DRV 600 mg as 100 milligram per millilitre (mg/mL) suspension and COBI 90 mg tablet under fed conditions on Day 1 of each treatment period.

    Primary: Maximum Observed Plasma Concentration (Cmax) of Darunavir (DRV)

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    End point title
    Maximum Observed Plasma Concentration (Cmax) of Darunavir (DRV)
    End point description
    Cmax was defined as the maximum observed plasma concentration of Darunavir. Pharmacokinetic (PK) data analysis set included all subjects who received at least 1 dose of study intervention and who had at least 1 plasma concentration data value/1 PK parameter value after study intervention administration.
    End point type
    Primary
    End point timeframe
    Pre dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36, 48, and 72 hours post dose on Day 1
    End point values
    Treatment A Treatment B
    Number of subjects analysed
    32
    30
    Units: Nanograms per millilitre (ng/mL)
        arithmetic mean (standard deviation)
    4945 ± 1269
    5014 ± 993
    Statistical analysis title
    Treatment A Versus Treatment B
    Statistical analysis description
    Log transformed PK parameters were analysed by a linear mixed-effect model that includes treatment, period, and treatment sequence as fixed effects and subject within sequence as a random effect. The results were back-transformed using anti-logarithm.
    Comparison groups
    Treatment A v Treatment B
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    equivalence [1]
    Method
    Parameter type
    Geometric Mean Ratio
    Point estimate
    96.85
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    88.94
         upper limit
    105.47
    Notes
    [1] - Subjects analysed for statistical analysis in both the treatments (in each Treatment A and Treatment B) as per assigned treatment sequence were 30. Pre-defined bioequivalence limits were 80 to 125%.

    Primary: Area Under the Concentration-time Curve From Time Zero to Last Quantifiable Time (AUC[0-last]) of DRV

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    End point title
    Area Under the Concentration-time Curve From Time Zero to Last Quantifiable Time (AUC[0-last]) of DRV
    End point description
    AUC(0-last) was area under the analyte concentration-time curve from time zero to the time of the last measurable (non-below quantification limit [non-BQL]) concentration, calculated by linear-linear trapezoidal summation. PK data analysis set included all subjects who received at least 1 dose of study intervention and who had at least 1 plasma concentration data value/1 PK parameter value after study intervention administration.
    End point type
    Primary
    End point timeframe
    Pre dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36, 48, and 72 hours post dose on Day 1
    End point values
    Treatment A Treatment B
    Number of subjects analysed
    32
    30
    Units: nanogram* hour per millilitre (ng*h/mL)
        arithmetic mean (standard deviation)
    51913 ± 21398
    50004 ± 13574
    Statistical analysis title
    Treatment A Versus Treatment B
    Statistical analysis description
    Log transformed PK parameters were analysed by a linear mixed-effect model that includes treatment, period, and treatment sequence as fixed effects and subject within sequence as a random effect. The results were back-transformed using anti-logarithm.
    Comparison groups
    Treatment A v Treatment B
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    equivalence [2]
    Method
    Parameter type
    Geometric Mean Ratio
    Point estimate
    98.22
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    92.46
         upper limit
    104.33
    Notes
    [2] - Subjects analysed for statistical analysis in both the treatments (in each Treatment A and Treatment B) as per assigned treatment sequence were 30. Pre-defined bioequivalence limits were 80 to 125%.

    Primary: Area Under the Concentration-time Curve from Time Zero to Infinite Time (AUC[0-infinity]) of DRV

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    End point title
    Area Under the Concentration-time Curve from Time Zero to Infinite Time (AUC[0-infinity]) of DRV
    End point description
    The AUC (0-infinity) was the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last) divided by lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant. PK data analysis set included all subjects who received at least 1 dose of study intervention and who had at least 1 plasma concentration data value/1 PK parameter value after study intervention administration. Here, ‘Number of Subjects Analysed’ = subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Pre dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36, 48, and 72 hours post dose on Day 1
    End point values
    Treatment A Treatment B
    Number of subjects analysed
    31
    30
    Units: nanogram* hour per millilitre (ng*h/mL)
        arithmetic mean (standard deviation)
    51823 ± 21745
    50167 ± 13599
    Statistical analysis title
    Treatment A Versus Treatment B
    Statistical analysis description
    Log transformed PK parameters were analysed by a linear mixed-effect model that includes treatment, period, and treatment sequence as fixed effects and subject within sequence as a random effect. The results were back-transformed using anti-logarithm.
    Comparison groups
    Treatment A v Treatment B
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    equivalence [3]
    Method
    Parameter type
    Geometric Mean Ratio
    Point estimate
    98.6
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    92.66
         upper limit
    104.91
    Notes
    [3] - Subjects analysed for statistical analysis in both the treatments (in each Treatment A and Treatment B) as per assigned treatment sequence were 29. Pre-defined bioequivalence limits were 80 to 125%.

    Secondary: Maximum Observed Plasma Concentration (Cmax) of Cobicistat (COBI)

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    End point title
    Maximum Observed Plasma Concentration (Cmax) of Cobicistat (COBI)
    End point description
    Cmax was defined as the maximum observed plasma concentration of cobicistat. PK data analysis set included all subjects who received at least 1 dose of study intervention and who had at least 1 plasma concentration data value/1 PK parameter value after study intervention administration.
    End point type
    Secondary
    End point timeframe
    Pre dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36, 48, and 72 hours post dose on Day 1
    End point values
    Treatment A Treatment B
    Number of subjects analysed
    32
    30
    Units: ng/mL
        arithmetic mean (standard deviation)
    221 ± 84.0
    295 ± 117
    Statistical analysis title
    Treatment A Versus Treatment B
    Statistical analysis description
    Log transformed PK parameters were analysed by a linear mixed-effect model that includes treatment, period, and treatment sequence as fixed effects and subject within sequence as a random effect. The results were back-transformed using anti-logarithm.
    Comparison groups
    Treatment A v Treatment B
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    equivalence [4]
    Method
    Parameter type
    Geometric Mean Ratio
    Point estimate
    74.18
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    66.68
         upper limit
    82.53
    Notes
    [4] - Subjects analysed for statistical analysis in both the treatments (in each Treatment A and Treatment B) as per assigned treatment sequence were 30. Pre-defined bioequivalence limits were 80 to 125%.

    Secondary: Area Under the Concentration-time Curve From Time Zero to Last Quantifiable Time (AUC[0-last]) of COBI

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    End point title
    Area Under the Concentration-time Curve From Time Zero to Last Quantifiable Time (AUC[0-last]) of COBI
    End point description
    AUC(0-last) was area under the analyte concentration-time curve from time zero to the time of the last measurable (non-BQL) concentration, calculated by linear-linear trapezoidal summation. PK data analysis set included all subjects who received at least 1 dose of study intervention and who had at least 1 plasma concentration data value/1 PK parameter value after study intervention administration.
    End point type
    Secondary
    End point timeframe
    Pre dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36, 48, and 72 hours post dose on Day 1
    End point values
    Treatment A Treatment B
    Number of subjects analysed
    32
    30
    Units: nanogram* hour per millilitre (ng*h/mL)
        arithmetic mean (standard deviation)
    1606 ± 742
    1869 ± 904
    Statistical analysis title
    Treatment A Versus Treatment B
    Statistical analysis description
    Log transformed PK parameters were analysed by a linear mixed-effect model that includes treatment, period, and treatment sequence as fixed effects and subject within sequence as a random effect. The results were back-transformed using anti-logarithm.
    Comparison groups
    Treatment A v Treatment B
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    equivalence [5]
    Method
    Parameter type
    Geometric Mean Ratio
    Point estimate
    85.23
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    77.72
         upper limit
    93.47
    Notes
    [5] - Subjects analysed for statistical analysis in both the treatments (in each Treatment A and Treatment B) as per assigned treatment sequence were 30. Pre-defined bioequivalence limits were 80 to 125%.

    Secondary: Area Under the Concentration-time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of COBI

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    End point title
    Area Under the Concentration-time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of COBI
    End point description
    The AUC (0-infinity) was the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant. PK data analysis set included all subjects who received at least 1 dose of study intervention and who had at least 1 plasma concentration data value/1 PK parameter value after study intervention administration. Here, ‘Number of Subjects Analysed’ = subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Pre dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36, 48, and 72 hours post dose on Day 1
    End point values
    Treatment A Treatment B
    Number of subjects analysed
    30
    30
    Units: nanogram* hour per millilitre (ng*h/mL)
        arithmetic mean (standard deviation)
    1678 ± 748
    1913 ± 917
    Statistical analysis title
    Treatment A Versus Treatment B
    Statistical analysis description
    Log transformed PK parameters were analysed by a linear mixed-effect model that includes treatment, period, and treatment sequence as fixed effects and subject within sequence as a random effect. The results were back-transformed using anti-logarithm.
    Comparison groups
    Treatment A v Treatment B
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    equivalence [6]
    Method
    Parameter type
    Geometric Mean Ratio
    Point estimate
    84.68
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    77.05
         upper limit
    93.08
    Notes
    [6] - Subjects analysed for statistical analysis in both the treatments (in each Treatment A and Treatment B) as per assigned treatment sequence were 28. Pre-defined bioequivalence limits were 80 to 125%.

    Secondary: Number of Subjects With Serious Adverse Events (SAEs)

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    End point title
    Number of Subjects With Serious Adverse Events (SAEs)
    End point description
    An adverse event (AE) was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product. Safety analysis set included all subjects who received at least one dose of study intervention.
    End point type
    Secondary
    End point timeframe
    From screening up to end of study (up to 7 weeks)
    End point values
    Treatment A Treatment B
    Number of subjects analysed
    32
    30
    Units: Subjects
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Clinically Significant Abnormalities in Physical Examinations

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    End point title
    Number of Subjects With Clinically Significant Abnormalities in Physical Examinations
    End point description
    Clinically significant abnormalities in physical examinations was reported in this endpoint. Physical examination included skin examination, height and body weight measurement. Safety analysis set included all subjects who received at least 1 dose of study intervention.
    End point type
    Secondary
    End point timeframe
    From screening up to end of study (up to 7 weeks)
    End point values
    Treatment A Treatment B
    Number of subjects analysed
    32
    30
    Units: Subjects
    0
    1
    No statistical analyses for this end point

    Secondary: Number of Subjects With Clinically Significant Abnormalities in Vital Sign

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    End point title
    Number of Subjects With Clinically Significant Abnormalities in Vital Sign
    End point description
    Abnormal vital parameters included pulse rate: abnormally low- less than or equal to (<=45) beats per minute (bpm), abnormally high- greater than or equal to (>=) 120 bpm; Systolic Blood Pressure (SBP): abnormally low <=90 millimeter of mercury (mmHg), Grade 1 (mild): >140 mmHg to <160 mmHg, Grade 2 (moderate): >=160 mmHg to <180 mmHg, Grade 3 (severe): >=180 mmHg; Diastolic BP: abnormally low <=50 mmHg, Grade 1 (mild): >90 mmHg to <100 mmHg, Grade 2 (moderate): >=100 mmHg to <110 mmHg, Grade 3 (severe): >=110 mmHg. Safety analysis set included all subjects who received at least one dose of study intervention.
    End point type
    Secondary
    End point timeframe
    From screening up to end of study (up to 7 weeks)
    End point values
    Treatment A Treatment B
    Number of subjects analysed
    32
    30
    Units: Subjects
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Clinically Significant Abnormalities in Clinical Laboratory Tests

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    End point title
    Number of Subjects With Clinically Significant Abnormalities in Clinical Laboratory Tests
    End point description
    Safety laboratory assessments included clinical chemistry, hematology, coagulation, urinalysis, and other screening tests. Abnormality was determined at the investigator's discretion. Safety analysis set included all subjects who received at least 1 dose of study intervention.
    End point type
    Secondary
    End point timeframe
    From screening up to end of study (up to 7 weeks)
    End point values
    Treatment A Treatment B
    Number of subjects analysed
    32
    30
    Units: Subjects
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From screening up to end of study (up to 7 weeks)
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    Treatment A
    Reporting group description
    Subjects received a single oral dose of Darunavir (DRV) (600 milligrams [mg]) and Cobicistat (COBI) (90 mg) as one fixed dose combination (FDC) tablet under fed conditions on Day 1 of each treatment period.

    Reporting group title
    Treatment B
    Reporting group description
    Subjects received a single oral dose of DRV 600 mg as 100 milligram per millilitre (mg/mL) suspension and COBI 90 mg tablet under fed conditions on Day 1 of each treatment period.

    Serious adverse events
    Treatment A Treatment B
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 30 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Treatment A Treatment B
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 32 (6.25%)
    3 / 30 (10.00%)
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 32 (6.25%)
    3 / 30 (10.00%)
         occurrences all number
    2
    3

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Feb 2022
    The original protocol dated 08 December 2021 was amended once (22 February 2022) to correct an inconsistency between the Schedule of Activities and Section 8.1.3 (Electrocardiograms) of the protocol. The requirement for an electrocardiogram (ECG) assessment on Day -1 was removed from the Schedule of Activities as ECG was only required during screening. A more detailed instruction regarding the allowed intake of paracetamol/acetaminophen was added.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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