Flag of the European Union EU Clinical Trials Register Help

Clinical trials

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

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

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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

    < Back to search results

    Download PDF

    Clinical Trial Results:
    An Open-label, Randomized Crossover Study to Obtain a Preliminary Estimate of the Bioavailability of Atazanavir and Cobicistat When Administered in an Age-appropriate Fixed‑dose Combination Formulation Compared with Coadministration of the Age-appropriate Atazanavir and Cobicistat Individual Formulations and to Assess Preliminary Palatability/Acceptability in Healthy Adults

    Summary
    EudraCT number
    		 2020-002885-15
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    06 Jan 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Dec 2021
    First version publication date
    03 Dec 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    AI424-567
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb
    Sponsor organisation address
    Chaussée de la Hulpe 185, Brussels, Belgium, 1170
    Public contact
    EU Study Start-Up Unit, Bristol-Myers Squibb International Corporation, Clinical.Trials@bms.com
    Scientific contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, Clinical.Trials@bms.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001465-PIP01-13
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    12 Nov 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Jan 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the bioavailability of ATV and COBI when administered as a mini-tablet formulation with coadministration as individual component formulations in healthy adults
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial participants were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Feb 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 34
    Worldwide total number of subjects
    34
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    34
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 34 participants were randomized and treated

    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
    		 Sequence Group 1 = A-B
    Arm description
    		 Participants are randomly assigned to receive treatment A on day 1. There is a 7-day wash-out period. Participants receive treatment B on day 8. Treatment A: Single oral dose of atazanavir (ATV) and cobicistat (COBI) mini-tablets (300 mg/150 mg), mixed with a small serving of food Treatment B: Single oral dose of atazanavir (ATV) powder (300 mg, mixed with a small serving of food) + cobicistat (COBI) tablet (150 mg) followed by 240 mL of water.
    Arm type
    		 Experimental

    Investigational medicinal product name
    EVOTAZ
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Chewable/dispersible tablet
    Routes of administration
    Other use
    Dosage and administration details
    once-daily (QD) fixed-dose combination (FDC) tablet comprising atazanavir (ATV) 300 mg and cobicistat (COBI) 150 mg, mixed with a small serving of food

    Investigational medicinal product name
    Cobicistat (COBI)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    150 mg

    Investigational medicinal product name
    Atazanavir (ATV)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral powder
    Routes of administration
    Oral use
    Dosage and administration details
    300 mg, mixed with a small serving of food

    Arm title
    		 Sequence Group 2 = B-A
    Arm description
    		 Participants are randomly assigned to receive treatment B on day 1. There is a 7-day wash-out period. Participants receive treatment A on day 8. Treatment A: Single oral dose of atazanavir (ATV) and cobicistat (COBI) mini-tablets (300 mg/150 mg), mixed with a small serving of food Treatment B: Single oral dose of atazanavir (ATV) powder (300 mg, mixed with a small serving of food) + cobicistat (COBI) tablet (150 mg) followed by 240 mL of water.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cobicistat (COBI)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    150 mg

    Investigational medicinal product name
    EVOTAZ
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Chewable/dispersible tablet
    Routes of administration
    Other use
    Dosage and administration details
    once-daily (QD) fixed-dose combination (FDC) tablet comprising atazanavir (ATV) 300 mg and cobicistat (COBI) 150 mg, mixed with a small serving of food

    Investigational medicinal product name
    Atazanavir (ATV)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral powder
    Routes of administration
    Oral use
    Dosage and administration details
    300 mg, mixed with a small serving of food

    Number of subjects in period 1
    		Sequence Group 1 = A-B Sequence Group 2 = B-A
    Started
    17
    17
    Completed
    17
    16
    Not completed
    0
    1
         Consent withdrawn by subject
    -
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Sequence Group 1 = A-B
    Reporting group description
    		 Participants are randomly assigned to receive treatment A on day 1. There is a 7-day wash-out period. Participants receive treatment B on day 8. Treatment A: Single oral dose of atazanavir (ATV) and cobicistat (COBI) mini-tablets (300 mg/150 mg), mixed with a small serving of food Treatment B: Single oral dose of atazanavir (ATV) powder (300 mg, mixed with a small serving of food) + cobicistat (COBI) tablet (150 mg) followed by 240 mL of water.

    Reporting group title
    Sequence Group 2 = B-A
    Reporting group description
    		 Participants are randomly assigned to receive treatment B on day 1. There is a 7-day wash-out period. Participants receive treatment A on day 8. Treatment A: Single oral dose of atazanavir (ATV) and cobicistat (COBI) mini-tablets (300 mg/150 mg), mixed with a small serving of food Treatment B: Single oral dose of atazanavir (ATV) powder (300 mg, mixed with a small serving of food) + cobicistat (COBI) tablet (150 mg) followed by 240 mL of water.

    Reporting group values
    		 Sequence Group 1 = A-B Sequence Group 2 = B-A Total
    Number of subjects
    		 17 17 34
    Age Categorical
    Units: Participants
        Adults (18-64 years)
    		 17 17 34
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 36.4 ( 7.3 ) 35.8 ( 7.3 ) -
    Gender Categorical
    Units: Participants
        Female
    		 6 5 11
        Male
    		 11 12 23
    Race
    Units: Subjects
        White
    		 7 10 17
        Black or African American
    		 10 6 16
        Other
    		 0 1 1
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 5 11 16
        Not Hispanic or Latino
    		 12 6 18

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Sequence Group 1 = A-B
    Reporting group description
    		 Participants are randomly assigned to receive treatment A on day 1. There is a 7-day wash-out period. Participants receive treatment B on day 8. Treatment A: Single oral dose of atazanavir (ATV) and cobicistat (COBI) mini-tablets (300 mg/150 mg), mixed with a small serving of food Treatment B: Single oral dose of atazanavir (ATV) powder (300 mg, mixed with a small serving of food) + cobicistat (COBI) tablet (150 mg) followed by 240 mL of water.

    Reporting group title
    Sequence Group 2 = B-A
    Reporting group description
    		 Participants are randomly assigned to receive treatment B on day 1. There is a 7-day wash-out period. Participants receive treatment A on day 8. Treatment A: Single oral dose of atazanavir (ATV) and cobicistat (COBI) mini-tablets (300 mg/150 mg), mixed with a small serving of food Treatment B: Single oral dose of atazanavir (ATV) powder (300 mg, mixed with a small serving of food) + cobicistat (COBI) tablet (150 mg) followed by 240 mL of water.

    Subject analysis set title
    Treatment A: ATV/COBI mini-tablets
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    1 X 300 mg ATV/150 mg COBI bottle of mini-tablets mixed with a small serving of chocolate pudding

    Subject analysis set title
    Treatment B: ATV powder and COBI tablet
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    6 X REYATAZ (ATV) 50-mg powder packets (300 mg total) mixed with a small serving of applesauce and 1 X COBI 150-mg tablet followed by 240 mL of water.

    Primary: Cmax: Maximum observed plasma concentration

    		 Close Top of page
    End point title
    		 Cmax: Maximum observed plasma concentration [1]
    End point description
    The maximum observed serum concentration was measured compare the bioavailability of Atazanavir (ATV) and Cobicistat (COBI) when administered as a mini-tablet formulation with co-administration as individual component formulations in healthy adults. Note: 99999 = NA
    End point type
    Primary
    End point timeframe
    Time points can include: Day 1 and 8 (Pre-dose, 1, 2, 2.30, 3, 4, 5, 6, 8, 12, and 16 hours post dose). Day 2 and 9 (24, 30, 36 hours post dose). Day 3 and 10 (48 hours post dose).
    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: Only summary statistics were planned for these endpoints
    End point values
    		 Treatment A: ATV/COBI mini-tablets Treatment B: ATV powder and COBI tablet
    Number of subjects analysed
    33
    33
    Units: ng/mL
    geometric mean (geometric coefficient of variation)
        Atazanavir
    2392.1 ( 99999 )
    3634.6 ( 99999 )
        Cobicistat
    1029.3 ( 99999 )
    1217.2 ( 99999 )
    No statistical analyses for this end point

    Primary: AUC(INF): Area under the plasma concentration-time curve from time zero extrapolated to infinite time

    		 Close Top of page
    End point title
    		 AUC(INF): Area under the plasma concentration-time curve from time zero extrapolated to infinite time [2]
    End point description
    The area under the plasma concentration-time curve from time zero extrapolated to infinite time was measured compare the bioavailability of Atazanavir (ATV) and Cobicistat (COBI) when administered as a mini-tablet formulation with co-administration as individual component formulations in healthy adults. Note: 99999 = NA
    End point type
    Primary
    End point timeframe
    Time points can include: Day 1 and 8 (Pre-dose, 1, 2, 2.30, 3, 4, 5, 6, 8, 12, and 16 hours post dose). Day 2 and 9 (24, 30, 36 hours post dose). Day 3 and 10 (48 hours post dose).
    Notes
    [2] - 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: Only summary statistics were planned for these endpoints
    End point values
    		 Treatment A: ATV/COBI mini-tablets Treatment B: ATV powder and COBI tablet
    Number of subjects analysed
    33
    33
    Units: ng.h/mL
    geometric mean (geometric coefficient of variation)
        Atazanavir
    22673.4 ( 99999 )
    34053.3 ( 99999 )
        Cobicistat
    7057.6 ( 99999 )
    8496.9 ( 99999 )
    No statistical analyses for this end point

    Secondary: Tmax: Time of maximum observed plasma concentration

    		 Close Top of page
    End point title
    		 Tmax: Time of maximum observed plasma concentration
    End point description
    The time of maximum observed plasma concentration was measured to assess the pharmacokinetics of Atazanavir (ATV) and Cobicistat (COBI) when administered as a mini-tablet formulation and when co-administered as individual component formulations in healthy adults. Note: 99999 = NA
    End point type
    Secondary
    End point timeframe
    Time points can include: Day 1 and 8 (Pre-dose, 1, 2, 2.30, 3, 4, 5, 6, 8, 12, and 16 hours post dose). Day 2 and 9 (24, 30, 36 hours post dose). Day 3 and 10 (48 hours post dose).
    End point values
    		 Treatment A: ATV/COBI mini-tablets Treatment B: ATV powder and COBI tablet
    Number of subjects analysed
    33
    33
    Units: Hours
    median (full range (min-max))
        Atazanavir
    2.050 (1.00 to 5.00)
    2.000 (1.00 to 4.00)
        Cobicistat
    2.500 (1.00 to 5.00)
    2.067 (1.00 to 5.00)
    No statistical analyses for this end point

    Secondary: T-HALF: Terminal plasma half-life

    		 Close Top of page
    End point title
    		 T-HALF: Terminal plasma half-life
    End point description
    The terminal plasma half-life was measured to assess the pharmacokinetics of Atazanavir (ATV) and Cobicistat (COBI) when administered as a mini-tablet formulation and when co-administered as individual component formulations in healthy adults. Note: 99999 = NA
    End point type
    Secondary
    End point timeframe
    Time points can include: Day 1 and 8 (Pre-dose, 1, 2, 2.30, 3, 4, 5, 6, 8, 12, and 16 hours post dose). Day 2 and 9 (24, 30, 36 hours post dose). Day 3 and 10 (48 hours post dose).
    End point values
    		 Treatment A: ATV/COBI mini-tablets Treatment B: ATV powder and COBI tablet
    Number of subjects analysed
    33
    33
    Units: Hour
    arithmetic mean (standard deviation)
        Atazanavir
    7.064 ( 1.696 )
    7.624 ( 1.954 )
        Cobicistat
    3.974 ( 0.837 )
    4.215 ( 0.901 )
    No statistical analyses for this end point

    Secondary: AUC(0-T): Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration

    		 Close Top of page
    End point title
    		 AUC(0-T): Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration
    End point description
    The area under the plasma concentration-time curve from time zero to time of last quantifiable concentration was measured to assess the pharmacokinetics of Atazanavir (ATV) and Cobicistat (COBI) when administered as a mini-tablet formulation and when co-administered as individual component formulations in healthy adults. Note: 99999 = NA
    End point type
    Secondary
    End point timeframe
    Time points can include: Day 1 and 8 (Pre-dose, 1, 2, 2.30, 3, 4, 5, 6, 8, 12, and 16 hours post dose). Day 2 and 9 (24, 30, 36 hours post dose). Day 3 and 10 (48 hours post dose).
    End point values
    		 Treatment A: ATV/COBI mini-tablets Treatment B: ATV powder and COBI tablet
    Number of subjects analysed
    33
    33
    Units: ng.h/mL
    geometric mean (geometric coefficient of variation)
        Atazanavir
    22304.4 ( 99999 )
    33422.7 ( 99999 )
        Cobicistat
    6870.0 ( 99999 )
    8280.3 ( 99999 )
    No statistical analyses for this end point

    Secondary: C24: Observed concentration at 24 hours

    		 Close Top of page
    End point title
    		 C24: Observed concentration at 24 hours
    End point description
    The observed concentration at 24 hours was measured to assess the pharmacokinetics of Atazanavir (ATV) and Cobicistat (COBI) when administered as a mini-tablet formulation and when co-administered as individual component formulations in healthy adults. Note: 99999 = NA
    End point type
    Secondary
    End point timeframe
    Time points can include: Day 1 and 8 (Pre-dose, 1, 2, 2.30, 3, 4, 5, 6, 8, 12, and 16 hours post dose). Day 2 and 9 (24, 30, 36 hours post dose). Day 3 and 10 (48 hours post dose).
    End point values
    		 Treatment A: ATV/COBI mini-tablets Treatment B: ATV powder and COBI tablet
    Number of subjects analysed
    33
    33
    Units: ng/mL
    geometric mean (geometric coefficient of variation)
        Atazanavir
    278.97 ( 99999 )
    434.51 ( 99999 )
        Cobicistat
    21.187 ( 99999 )
    27.828 ( 99999 )
    No statistical analyses for this end point

    Secondary: The Number of Participants Experiencing Adverse Events (AEs)

    		 Close Top of page
    End point title
    		 The Number of Participants Experiencing Adverse Events (AEs)
    End point description
    The number of participants experiencing adverse events (AEs) to assess the safety and tolerability of Atazanavir (ATV) and Cobicistat (COBI) when administered as a mini-tablet formulation and when co-administered as individual component formulations in healthy adults. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
    End point type
    Secondary
    End point timeframe
    From first dose up to approximately 1 year
    End point values
    		 Treatment A: ATV/COBI mini-tablets Treatment B: ATV powder and COBI tablet
    Number of subjects analysed
    34
    34
    Units: Participants
    2
    2
    No statistical analyses for this end point

    Secondary: The Number of Participants Experiencing Serious Adverse Events (SAEs)

    		 Close Top of page
    End point title
    		 The Number of Participants Experiencing Serious Adverse Events (SAEs)
    End point description
    The number of participants experiencing serious adverse events (SAEs) to assess the safety and tolerability of Atazanavir (ATV) and Cobicistat (COBI) when administered as a mini-tablet formulation and when co-administered as individual component formulations in healthy adults. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, and is an important medical event
    End point type
    Secondary
    End point timeframe
    From first dose up to approximately 1 year
    End point values
    		 Treatment A: ATV/COBI mini-tablets Treatment B: ATV powder and COBI tablet
    Number of subjects analysed
    34
    34
    Units: Participants
    0
    0
    No statistical analyses for this end point

    Secondary: The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation

    		 Close Top of page
    End point title
    		 The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
    End point description
    The number of participants experiencing adverse events (AEs) leading to discontinuation to assess the safety and tolerability of Atazanavir (ATV) and Cobicistat (COBI) when administered as a mini-tablet formulation and when co-administered as individual component formulations in healthy adults. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
    End point type
    Secondary
    End point timeframe
    From first dose up to approximately 1 year
    End point values
    		 Treatment A: ATV/COBI mini-tablets Treatment B: ATV powder and COBI tablet
    Number of subjects analysed
    34
    34
    Units: Participants
    0
    0
    No statistical analyses for this end point

    Secondary: The Number of Participants Deaths

    		 Close Top of page
    End point title
    		 The Number of Participants Deaths
    End point description
    The number of participants deaths to assess the safety and tolerability of Atazanavir (ATV) and Cobicistat (COBI) when administered as a mini-tablet formulation and when co-administered as individual component formulations in healthy adults.
    End point type
    Secondary
    End point timeframe
    From first dose up to approximately 1 year
    End point values
    		 Treatment A: ATV/COBI mini-tablets Treatment B: ATV powder and COBI tablet
    Number of subjects analysed
    34
    34
    Units: Participants
    0
    0
    No statistical analyses for this end point

    Secondary: The Number of Participants Experiencing Clinical Laboratory Abnormalities

    		 Close Top of page
    End point title
    		 The Number of Participants Experiencing Clinical Laboratory Abnormalities
    End point description
    The number of participants experiencing clinical laboratory abnormalities to assess the safety and tolerability of Atazanavir (ATV) and Cobicistat (COBI) when administered as a mini-tablet formulation and when co-administered as individual component formulations in healthy adults.
    End point type
    Secondary
    End point timeframe
    Clinical laboratory tests performed on Days -1 and 7
    End point values
    		 Treatment A: ATV/COBI mini-tablets Treatment B: ATV powder and COBI tablet
    Number of subjects analysed
    34
    34
    Units: Participants
        LOW NEUTROPHILS (ABSOLUTE) (X10*9 C/L)
    1
    2
        HIGH ALANINE AMINOTRANSFERASE (ALT)(U/L)
    1
    1
        HIGH BILIRUBIN, TOTAL (UMOL/L)
    1
    3
        HIGH BILIRUBIN, DIRECT (UMOL/L)
    1
    0
        HIGH WHITE BLOOD CELL, URINE (HPF)
    0
    1
    No statistical analyses for this end point

    Secondary: The number of Participants with Out-of-Range Vital Sign Findings

    		 Close Top of page
    End point title
    		 The number of Participants with Out-of-Range Vital Sign Findings
    End point description
    The number of participants who experienced out of range vital sign findings during the course of the study. The following parameters were analyzed for vital sign examination: body temperature, respiratory rate, and seated blood pressure and heart rate. Blood pressure and heart rate should be measured after the participant has been resting quietly for at least 5 minutes.
    End point type
    Secondary
    End point timeframe
    Screening, Pre-dose on Days 1 and 8 for blood pressure and heart rate only. Full vital signs at study discharge (The approximate duration of this study will be 38 days, including a 28-day screening period and a 10-day treatment period.)
    End point values
    		 Treatment A: ATV/COBI mini-tablets Treatment B: ATV powder and COBI tablet
    Number of subjects analysed
    34
    34
    Units: vital sign measurements
    4
    4
    No statistical analyses for this end point

    Secondary: The number of Participants with Electrocardiogram (ECG) abnormalities Identified by the Investigator

    		 Close Top of page
    End point title
    		 The number of Participants with Electrocardiogram (ECG) abnormalities Identified by the Investigator
    End point description
    The number of participants who experienced a clinically relevant electrocardiogram (ECG) finding during the course of the study. Parameters Include: PR Interval (msec), QRS Duration (msec), QT Interval (msec), QTcF Interval (msec).
    End point type
    Secondary
    End point timeframe
    From screening to 10 days after second treatment dose
    End point values
    		 Sequence Group 1 = A-B Sequence Group 2 = B-A
    Number of subjects analysed
    17
    17
    Units: ECG recordings
    9
    14
    No statistical analyses for this end point

    Secondary: Palatability Questionnaire Results

    		 Close Top of page
    End point title
    		 Palatability Questionnaire Results
    End point description
    The number of participants in each Palatability questionnaire category to assess the acceptability and palatability of the ATV/COBI mini-tablet formulation in healthy adults. A palatability assessment will be completed for the ATV/COBI mini-tablets only (Treatment A)
    End point type
    Secondary
    End point timeframe
    Within 5 minutes post dose on Day 1 or 8.
    End point values
    		 Treatment A: ATV/COBI mini-tablets
    Number of subjects analysed
    34
    Units: Participants
        Liked Treatment A
    20
        Neither liked nor disliked Treatment A
    11
        Disliked Treatment A
    3
        Reported not chewing before swallowing
    23
        Reported first impulse was to swallow
    20
        Reported neither was their first impulse
    3
        Rated a strong sweetness intensity
    15
        Rated a moderate sweetness intensity
    10
        Rated a weak sweetness intensity
    9
        Rated a sweetness level just about right
    20
        Rated a weak bitterness intensity
    16
        Rated a strong bitterness intensity
    13
        Rated a moderate bitterness intensity
    5
        Rated a bitterness level just about right
    11
        Rated a weak saltiness intensity
    13
        Rated a moderate saltiness intensity
    7
        Rated a saltiness level just about right
    13
        Rated a weak sourness intensity
    13
        Rated a sourness level just about right
    11
        Rated a sourness level much too weak
    10
        Rated a moderate astringency intensity
    10
        Rated a weak astringency intensity
    9
        Rated an astringency level just about right
    14
        Rated a moderate sandiness/grittiness intensity
    9
        Rated a weak sandiness/grittiness intensity
    8
        Rated sandiness/grittiness level just about right
    15
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information [1]
    Timeframe for reporting adverse events
    From 1st dose to 100 days after last dose (Up to approximately 110 days)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Treatment B: ATV powder and COBI tablet
    Reporting group description
    		 6 X REYATAZ (ATV) 50-mg powder packets (300 mg total) mixed with a small serving of applesauce and 1 X COBI 150-mg tablet followed by 240 mL of water.

    Reporting group title
    Treatment A: ATV/COBI mini-tablets
    Reporting group description
    		 1 X 300 mg ATV/150 mg COBI bottle of mini-tablets mixed with a small serving of chocolate pudding

    Serious adverse events
    		 Treatment B: ATV powder and COBI tablet Treatment A: ATV/COBI mini-tablets
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Treatment B: ATV powder and COBI tablet Treatment A: ATV/COBI mini-tablets
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: There are no non-serious adverse events in this study

    More information

    		 Close Top of page

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

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

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

    European Medicines Agency © 1995-Mon Apr 29 18:22:20 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA