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    Clinical Trial Results:
    A Single-Dose, Open-Label, Randomized, Replicate Crossover Pivotal Bioequivalence Study in Healthy Subjects to Assess the Bioequivalence of Darunavir 675 mg, Emtricitabine 200 mg, and Tenofovir Alafenamide 10 mg in the Presence of Cobicistat 150 mg when Administered as a Fixed Dose Combination (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide) Compared to the Co-administration of the Separate Agents (Darunavir, Cobicistat, and Emtricitabine/Tenofovir Alafenamide), Under Fed Conditions

    Summary
    EudraCT number
    		 2019-002245-37
    Trial protocol
    		 NL  
    Global end of trial date
    10 Apr 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 May 2021
    First version publication date
    16 May 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TMC114FD2HTX1005
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04236453
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen-Cilag International N.V.
    Sponsor organisation address
    Archimedesweg 29, Leiden, Netherlands, 2333 CM
    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-001825-PIP01-15
    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
    05 Oct 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Apr 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main objective of this study is to evaluate the single-dose pharmacokinetic (PK) and pivotal bioequivalence of 3 compounds darunavir (DRV/D) 675 milligrams (mg), emtricitabine (FTC/F) 200 mg, and tenofovir alafenamide (TAF) 10 mg in the presence of cobicistat (COBI/C) 150 mg when administered as an fixed dose combination (FDC) (D/C/F/TAF) compared to the co-administration of the separate commercial formulations (DRV 1*600 mg and 1*75 mg tablets and F/TAF 1*200 mg/10 mg tablet and COBI 1*150 mg tablet), under fed conditions, in healthy subjects.
    Protection of trial subjects
    Safety evaluations were based upon the type, incidence, and severity of treatment-emergent adverse events reported throughout the study, and on changes in vital sign measurements, electrocardiogram (ECG), clinical laboratory test results, physical examinations and allergic reactions.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 Jan 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
    Netherlands: 16
    Worldwide total number of subjects
    16
    EEA total number of subjects
    16
    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)
    16
    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 16 subjects were randomized; 8 subjects each in Treatment Sequence ABBA and Treatment Sequence BAAB. Only 2 subjects completed the study.

    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 ABBA
    Arm description
    		 Subjects received a single oral dose of Darunavir (675 milligrams [mg])/Cobicistat (150 mg)/Emtricitabine (200 mg)/Tenofovir Alafenamide (10 mg) as one fixed dose combination (FDC) tablet (D/C/F/TAF) under fed conditions (Treatment A, test) on Day 1 of Period 1 followed by a single oral dose of Darunavir (DRV) 600 and 75 mg tablet, Emtricitabine 200 mg/Tenofovir Alafenamide 10 mg (F/TAF) and Cobicistat (COBI) 150 mg tablet under fed conditions (Treatment B, reference) on Day 1 of Period 2 followed by Treatment B again on Day 1 of Period 3 and, then Treatment A on Day 1 of Period 4. Each period is separated by a washout period of 7 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Darunavir 675 mg/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir Alafenamide (10 mg) (D/C/F/TAF) FDC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received a single dose of D/C/F/TAF 675/150/200/10 mg FDC tablets orally as Treatment A on Day 1 per assigned treatment sequences.

    Investigational medicinal product name
    Emtricitabine 200 mg/Tenofovir Alafenamide 10 mg (F/TAF)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received a single dose of E/TAF 200/10mg tablets orally as Treatment B on Day 1 per assigned treatment sequences.

    Investigational medicinal product name
    Cobicistat (COBI) 150 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received a single dose of COBI 150 mg tablets orally as Treatment B on Day 1 per assigned treatment sequences.

    Investigational medicinal product name
    Darunavir (DRV) 600 and 75 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received a single dose of DRV 600 and 75 mg tablets orally as Treatment B on Day 1 per assigned treatment sequences.

    Arm title
    		 Treatment Sequence BAAB
    Arm description
    		 Subjects received a single oral dose of DRV 600 and 75 mg tablet, F/TAF 200/10 mg and COBI 150 mg tablet under fed conditions (Treatment B, reference) on Day 1 of Period 1 followed by a single oral dose D/C/F/TAF 675/150/200/10 mg as one fixed dose combination (FDC) tablet under fed conditions (Treatment A, test) on Day 1 of Period 2 followed by a followed by Treatment A on Day 1 of Period 3 and, then Treatment B on Day 1 of Period 4. Each period is separated by a washout period of 7 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Darunavir (DRV) 600 and 75 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received a single dose of DRV 600 and 75 mg tablets orally as Treatment B on Day 1 per assigned treatment sequences.

    Investigational medicinal product name
    Darunavir 675 mg/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir Alafenamide (10 mg) (D/C/F/TAF) FDC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received a single dose of D/C/F/TAF 675/150/200/10 mg FDC tablets orally as Treatment A on Day 1 per assigned treatment sequences.

    Investigational medicinal product name
    Darunavir (DRV) 600 and 75 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received a single dose of DRV 600 and 75 mg tablets orally as Treatment B on Day 1 per assigned treatment sequences.

    Investigational medicinal product name
    Emtricitabine 200 mg/Tenofovir Alafenamide 10 mg (F/TAF)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received a single dose of E/TAF 200/10mg tablets orally as Treatment B on Day 1 per assigned treatment sequences.

    Number of subjects in period 1
    		Treatment Sequence ABBA Treatment Sequence BAAB
    Started
    8
    8
    Completed
    2
    0
    Not completed
    6
    8
         Unspecified
    -
    1
         Study Terminated by Sponsor
    6
    7

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment Sequence ABBA
    Reporting group description
    		 Subjects received a single oral dose of Darunavir (675 milligrams [mg])/Cobicistat (150 mg)/Emtricitabine (200 mg)/Tenofovir Alafenamide (10 mg) as one fixed dose combination (FDC) tablet (D/C/F/TAF) under fed conditions (Treatment A, test) on Day 1 of Period 1 followed by a single oral dose of Darunavir (DRV) 600 and 75 mg tablet, Emtricitabine 200 mg/Tenofovir Alafenamide 10 mg (F/TAF) and Cobicistat (COBI) 150 mg tablet under fed conditions (Treatment B, reference) on Day 1 of Period 2 followed by Treatment B again on Day 1 of Period 3 and, then Treatment A on Day 1 of Period 4. Each period is separated by a washout period of 7 days.

    Reporting group title
    Treatment Sequence BAAB
    Reporting group description
    		 Subjects received a single oral dose of DRV 600 and 75 mg tablet, F/TAF 200/10 mg and COBI 150 mg tablet under fed conditions (Treatment B, reference) on Day 1 of Period 1 followed by a single oral dose D/C/F/TAF 675/150/200/10 mg as one fixed dose combination (FDC) tablet under fed conditions (Treatment A, test) on Day 1 of Period 2 followed by a followed by Treatment A on Day 1 of Period 3 and, then Treatment B on Day 1 of Period 4. Each period is separated by a washout period of 7 days.

    Reporting group values
    		 Treatment Sequence ABBA Treatment Sequence BAAB Total
    Number of subjects
    		 8 8 16
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-55 years)
    		 8 8 16
        From 55to 84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 37.6 ( 12.99 ) 34.8 ( 12.48 ) -
    Title for Gender
    Units: subjects
        Female
    		 2 1 3
        Male
    		 6 7 13

    End points

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    End points reporting groups
    Reporting group title
    Treatment Sequence ABBA
    Reporting group description
    		 Subjects received a single oral dose of Darunavir (675 milligrams [mg])/Cobicistat (150 mg)/Emtricitabine (200 mg)/Tenofovir Alafenamide (10 mg) as one fixed dose combination (FDC) tablet (D/C/F/TAF) under fed conditions (Treatment A, test) on Day 1 of Period 1 followed by a single oral dose of Darunavir (DRV) 600 and 75 mg tablet, Emtricitabine 200 mg/Tenofovir Alafenamide 10 mg (F/TAF) and Cobicistat (COBI) 150 mg tablet under fed conditions (Treatment B, reference) on Day 1 of Period 2 followed by Treatment B again on Day 1 of Period 3 and, then Treatment A on Day 1 of Period 4. Each period is separated by a washout period of 7 days.

    Reporting group title
    Treatment Sequence BAAB
    Reporting group description
    		 Subjects received a single oral dose of DRV 600 and 75 mg tablet, F/TAF 200/10 mg and COBI 150 mg tablet under fed conditions (Treatment B, reference) on Day 1 of Period 1 followed by a single oral dose D/C/F/TAF 675/150/200/10 mg as one fixed dose combination (FDC) tablet under fed conditions (Treatment A, test) on Day 1 of Period 2 followed by a followed by Treatment A on Day 1 of Period 3 and, then Treatment B on Day 1 of Period 4. Each period is separated by a washout period of 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 675 milligrams (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir Alafenamide 10 mg as one fixed dose combination (FDC) tablet (D/C/F/TAF) under fed conditions on Day 1.

    Subject analysis set title
    Treatment B
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects received a single oral dose of Darunavir (DRV) 600 and 75 mg, Emtricitabine 200 mg/Tenofovir Alafenamide 10 mg (F/TAF) and Cobicistat (COBI) 150 mg tablet under fed conditions on Day 1.

    Primary: Maximum Observed Analyte Concentration (Cmax) of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF)

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    End point title
    		 Maximum Observed Analyte Concentration (Cmax) of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) [1]
    End point description
    Cmax is the maximum observed analyte concentration. Pharmacokinetic (PK) analysis set included all subjects who have received at least one dose of study drug and had PK sampling done.
    End point type
    Primary
    End point timeframe
    Up to 72 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: No inferential statistical analyses was planned to report for the primary end point.
    End point values
    		 Treatment Sequence ABBA Treatment Sequence BAAB
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: nanogram per milliliter (ng/mL)
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [2] - Due to batch expiry, the PK samples collected during the study were not analyzed and destroyed.
    [3] - Due to batch expiry, the PK samples collected during the study were not analyzed and destroyed.
    No statistical analyses for this end point

    Primary: Area Under the Analyte Concentration-time Curve From Time Zero to Time of the Last Observed Quantifiable Concentration (AUC [0-last]) of Darunavir, Cobicistat, Emtricitabine and Tenofovir Alafenamide

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    End point title
    		 Area Under the Analyte Concentration-time Curve From Time Zero to Time of the Last Observed Quantifiable Concentration (AUC [0-last]) of Darunavir, Cobicistat, Emtricitabine and Tenofovir Alafenamide [4]
    End point description
    AUC(0-last) is area under the analyte concentration-time curve from time zero to the time of the last observed quantifiable concentration, calculated by linear-linear trapezoidal summation. PK analysis set included all subjects who have received at least one dose of study drug and had PK sampling done.
    End point type
    Primary
    End point timeframe
    Up to 72 hours post-dose
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No inferential statistical analyses was planned to report for the primary end point.
    End point values
    		 Treatment Sequence ABBA Treatment Sequence BAAB
    Number of subjects analysed
    0 [5]
    0 [6]
    Units: nanogram*hour per milliliter (ng*h/mL)
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [5] - Due to batch expiry, the PK samples collected during the study were not analyzed and destroyed.
    [6] - Due to batch expiry, the PK samples collected during the study were not analyzed and destroyed.
    No statistical analyses for this end point

    Secondary: Area Under the Analyte Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of of Darunavir, Cobicistat, Emtricitabine and Tenofovir Alafenamide

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    End point title
    		 Area Under the Analyte Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of of Darunavir, Cobicistat, Emtricitabine and Tenofovir Alafenamide
    End point description
    The AUC (0-infinity) is the area under the analyte 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 analyte 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 analysis set included all subjects who have received at least one dose of study drug and had PK sampling done.
    End point type
    Secondary
    End point timeframe
    Up to 72 hours post-dose
    End point values
    		 Treatment Sequence ABBA Treatment Sequence BAAB
    Number of subjects analysed
    0 [7]
    0 [8]
    Units: ng*h/mL
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [7] - Due to batch expiry, the PK samples collected during the study were not analyzed and destroyed.
    [8] - Due to batch expiry, the PK samples collected during the study were not analyzed and destroyed.
    No statistical analyses for this end point

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

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    End point title
    		 Maximum Observed Analyte Concentration (Cmax) of Cobicistat (COBI)
    End point description
    Cmax is the maximum observed analyte concentration. PK analysis set included all subjects who have received at least one dose of study drug and had PK sampling done.
    End point type
    Secondary
    End point timeframe
    Up to 72 hours post-dose
    End point values
    		 Treatment Sequence ABBA Treatment Sequence BAAB
    Number of subjects analysed
    0 [9]
    0 [10]
    Units: ng/mL
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [9] - Due to batch expiry, the PK samples collected during the study were not analyzed and destroyed.
    [10] - Due to batch expiry, the PK samples collected during the study were not analyzed and destroyed.
    No statistical analyses for this end point

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

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    End point title
    		 Area Under the Analyte Concentration-time Curve From Time Zero to Time of the Last Observed Quantifiable Concentration (AUC [0-last]) of COBI
    End point description
    AUC(0-last) is area under the analyte concentration-time curve from time zero to the time of the last observed quantifiable concentration. PK analysis set included all subjects who have received at least one dose of study drug and had PK sampling done.
    End point type
    Secondary
    End point timeframe
    Up to 72 hours post-dose
    End point values
    		 Treatment Sequence ABBA Treatment Sequence BAAB
    Number of subjects analysed
    0 [11]
    0 [12]
    Units: ng*h/mL
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [11] - Due to batch expiry, the PK samples collected during the study were not analyzed and destroyed.
    [12] - Due to batch expiry, the PK samples collected during the study were not analyzed and destroyed.
    No statistical analyses for this end point

    Secondary: Number of Subjects with Adverse Events

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    End point title
    		 Number of Subjects with Adverse Events
    End point description
    An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Safety analysis set included subjects who were administered at least one dose of the study drug.
    End point type
    Secondary
    End point timeframe
    From signing of the Informed consent form (ICF) till the last study-related activity (up to 9 weeks)
    End point values
    		 Treatment A‌ Treatment B
    Number of subjects analysed
    13
    12
    Units: Subjects
    4
    6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From signing of the Informed consent form (ICF) till the last study-related activity (up to 9 weeks)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Treatment B
    Reporting group description
    		 Subjects received a single oral dose of Darunavir (DRV) 600 and 75 mg, Emtricitabine 200 mg/Tenofovir Alafenamide 10 mg (F/TAF) and Cobicistat (COBI) 150 mg tablet under fed conditions on Day 1.

    Reporting group title
    Treatment A
    Reporting group description
    		 Subjects received a single oral dose of Darunavir 675 milligrams (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir Alafenamide 10 mg as one fixed dose combination (FDC) tablet (D/C/F/TAF) under fed conditions on Day 1.

    Serious adverse events
    		 Treatment B Treatment A
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Treatment B Treatment A
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 12 (50.00%)
    4 / 13 (30.77%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 12 (16.67%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    Headache
         subjects affected / exposed
    2 / 12 (16.67%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    General disorders and administration site conditions
    Catheter Site Haematoma
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Catheter Site Irritation
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Fatigue
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Influenza Like Illness
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal Pain Lower
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Faeces Soft
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Flatulence
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    2 / 12 (16.67%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal Pain
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Rash Macular
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Rash Pruritic
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Infections and infestations
    Rhinitis
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0

    More information

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

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The study was terminated by the Sponsor due to COVID-19, as the measures taken at the clinical site did not allow to complete the study before batch expiry of reference and test products, impacting the PK assessments of the enrolled subjects.
    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.

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