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    Summary
    EudraCT Number:2015-001967-38
    Sponsor's Protocol Code Number:SMTC11004
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-07-20
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2015-001967-38
    A.3Full title of the trial
    A Phase I, 2-Part, Open-label, Multiple Oral Dose Study of the Safety, Tolerability and Pharmacokinetics of up to 2 Formulations of SMT C1100 in Healthy Adult Male Subjects and a Selected Formulation of SMT C1100 in Paediatric Subjects with Duchenne Muscular Dystrophy (DMD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A research project for boys with Duchenne muscular dystrophy aged 5-9 years. It aims to find out how safe and well tolerated different doses of the experimental medicine are, when given by mouth after breakfast and evening meal.
    A.3.2Name or abbreviated title of the trial where available
    SMTC11004 - Phase 1 study in healthy volunteers and DMD patients
    A.4.1Sponsor's protocol code numberSMTC11004
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSummit (Oxford) Limited
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSummit (Oxford) Limited
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street Address85b Park Drive, Milton Park
    B.5.3.2Town/ cityAbingdon
    B.5.3.3Post codeOX14 4RY
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01235 443977
    B.5.6E-mailDMDphase1studies@summitplc.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/08/591
    D.3 Description of the IMP
    D.3.1Product nameSMT C1100 (F5; nanosuspension)
    D.3.2Product code SMT C1100 (F5)
    D.3.4Pharmaceutical form Oral suspension
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeSMT-C1100
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/08/591
    D.3 Description of the IMP
    D.3.1Product nameSMT C1100 (F6; Powder for Oral Suspension)
    D.3.2Product code SMT C1100 (F6)
    D.3.4Pharmaceutical form Powder for oral suspension
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeSMT-C1100
    D.3.9.4EV Substance CodeAS3
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Duchenne muscular dystrophy (DMD)
    E.1.1.1Medical condition in easily understood language
    A progressive, lethal muscle wasting disease, characterised by a generalised weakness and progressive loss of muscle strength; cardiac and respiratory difficulties present, leading to death
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10013801
    E.1.2Term Duchenne muscular dystrophy
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary purpose of this study (part A) is to investigate how the body handles 2 formulations of SMT C1100 with respect to levels of parent compound and its breakdown products in healthy adult male volunteers.

    The primary purpose in Part B is to determine how the body handles the multiple dose of SMT C1100 and its breakdown products, following oral administration of up to 3 different dose levels of the formulation of SMT C1100 selected from Part A, in DMD (Duchenne Muscular Dystrophy) children.
    E.2.2Secondary objectives of the trial
    The secondary research objectives are as follow:

    Part A
    1) To determine the safety and tolerability of SMT C1100 and its breakdown products with either 1 or 2 different oral (via the mouth) formulations of SMT C1100 in healthy adult subjects.
    2) To explore the effect of intake of food in comparison to a fasting condition (without food) in how the body handles SMT C1100 and its breakdown products for either 1 or 2 different oral formulations of SMT C1100 in healthy adult subjects.
    3) To compare the differences in levels of SMT C1100 between the morning and evening doses.

    Part B
    1) To determine the safety and tolerability of SMC C1100 and its breakdown products in children with DMD.
    2) To investigate the variations in how the body handles SMT C1100 when is given as a morning dose compared with the situation when it is given as an evening dose.


    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Part A:
    1. Males of any ethnic origin aged 18 to 55 years inclusive and with body weight of 60 to 85 kg inclusive and a body mass index (BMI) of 18.5 to 30 kg/m2 inclusive.
    2. In good health, as determined by a medical history, physical examination, 12-lead ECG and clinical laboratory evaluations (congenital non-haemolytic hyperbilirubinaemia, Gilbert’s syndrome, is acceptable).
    3. Subjects who are non-smokers and do not use other tobacco or nicotine products for at least 60 days preceding screening and are willing and able to refrain from smoking, tobacco, and nicotine products until after completion of the follow up visit.
    4. Willing and able to give written informed consent to participate in the study and to abide by the study restrictions.

    Part B:
    1. Male children aged 5 to 9 years inclusive of any ethnic origin with a genetic diagnosis of DMD.
    2. The subject is willing to give verbal or written age appropriate assent to participate. A parent/legal guardian must date and sign a written consent on behalf of the subject, according to ICH and local regulations. This person must understand the contents of the consent, requirements of the study and have had an opportunity to review questions with a medically trained member of the site study team. For safety reasons, the subject’s parent/legal guardian must have a good understanding of the English language, in which the consent/assent forms are available, and understand the requirements for reporting of any AE to the Investigator.
    3. The subject has 3 months or more stable systemic (subjects using an intermittent regimen of steroid are allowed to be enrolled) corticosteroid therapy prior to Screening. Dose modifications for body weight are permitted.
    4. The subject has a North Star Ambulatory Assessment (NSAA) score; a historical NSAA score maybe provided if performed within 30 days prior to the Screening visit. The subject should have a minimum NSAA score of 17.
    5. The subject and parent are willing for the subject to adhere to a balanced diet from 1 week prior to dosing until the end of the follow-up period.
    6. Subjects must agree to not have sexual intercourse during the study treatment phases and until the end of their participation in the study
    E.4Principal exclusion criteria
    Part A:
    1. Not willing, or partners not willing, to use appropriate contraception, or not willing to avoid donating sperm from time of first dose until 3 months after final dose
    2. Received any prescribed systemic or topical medication within 14 days of first dose unless in the opinion of the Investigator it will not interfere with the study procedures or compromise safety
    3. Used any non-prescribed systemic or topical medication (including herbal remedies) within 7 days of the first dose (with the exception of vitamin/mineral supplements) unless in the opinion of the Investigator it will not interfere with the study procedures or compromise safety
    4. Received any medications, including St John’s Wort, known to chronically alter drug absorption or elimination processes within 30 days of first dose unless in the opinion of the Investigator it will not interfere with the study procedures or compromise safety
    5. Still participating or has participated in a clinical study involving administration of an investigational drug in the past 3 months
    6. Has donated any blood, plasma or platelets in the 3 months prior to screening or who have made donations on more than two occasions within the 12 months preceding first dose
    7. Significant history of drug allergy as determined by the Investigator, or any clinically significant allergic disease (excluding non-active hay fever) as determined by the Investigator
    8. Known hypersensitivity to the excipients of the study drug or potential reconstitution vehicle
    9. Subject is dairy or lactose intolerant, has an allergy to egg or nuts or any other dietary restrictions that might interfere with the study conduct
    10. Supine blood pressure and/or supine pulse rate higher than 150/90 mmHg and 110 beats per minute (bpm), or lower than 90/40 mmHg and/or 40 bpm, after 5 minutes rest, confirmed by a repeat assessment
    11. Consumes more than 28 units of alcohol per week or has a significant history of alcoholism or drug/chemical abuse as determined by the Investigator
    12. Positive urine drug, alcohol or cotinine result at screening or admission to the clinical unit
    13. History of, any clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological or other major disorders as determined by the Investigator
    14. Clinically significant illness within 4 weeks of start of dose
    15. Known to have serum hepatitis, or tests positive for hepatitis B surface antigen, hepatitis C antibody or human immunodeficiency virus (HIV) I or II tests at screening
    16. Abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risk of participating in the study
    17. Subjects who, in the opinion of the Investigator, should not participate in the study
    18. Vegans or medical dietary restrictions
    19. Cannot communicate reliably with the Investigator
    20. Unlikely to co-operate with the study requirements

    Part B:
    1. Enrolment or participation in any therapeutic clinical trial within prior 3 months or 5 times the half-life (whichever is longer)
    2. Known hypersensitivity to the excipients of the study drug or potential reconstitution vehicle or a previous history of drug allergy
    3. Subject or parent/legal guardian is unwilling for the subject to adhere to a balanced diet from 1 week prior to dosing until the end of the follow-up period.4. Subject is dairy or lactose intolerant, has an allergy to egg or nuts or any other dietary restrictions that might interfere with the conduct of the study
    5. Subject unable to refrain from eating cruciferous vegetables and barbecued meat for the duration of the study
    6. Use of prohibited medication
    7. Subject has intermittent/continuous difficulties in swallowing
    8. Subject is non ambulatory
    9. Any clinically significant acute illness within 4 weeks of the start of dose administration
    10. Any comorbidity, in the opinion of the Investigator, increases the risk of participating in the study
    11. Symptomatic cardiomyopathy in the opinion of the Investigator prohibits participation in this study
    12. Abnormality in the 12-lead ECG at the Screening visit that, in the opinion of the Investigator, is clinically significant
    13. Any clinically significant medical condition, other than DMD, that in the opinion of the Investigator may increase the risk of participating in the study or interfere with the interpretation of safety or efficacy evaluations
    14. The subject smokes, uses other tobacco or nicotine products or has exposure to daily passive smoking
    15. Subjects with respiratory insufficiency requiring mechanical ventilation during the study
    16-18. Subjects using an inhibitor, inducer or substrate of CYP1A1, CYP1A2 or CYP2B6
    19. All prescription, OTC & herbal products that are known CYP2B6 sensitive substrates as well as CYP2B6 inhibitors or inducers will be excluded 14 days prior to study through to 14 days after study completion
    E.5 End points
    E.5.1Primary end point(s)
    Part A:
    To determine the multiple dose PK of SMT C1100 and its dihydrodiol (DHD) metabolites at 2 dose levels following oral administration with up to 2 different formulations of SMT C1100

    Part B:
    To determine the multiple dose PK of SMT C1100 and its 2 DHD metabolites, following oral administration of up to 3 ascending dose regimens of the formulation of SMT C1100 selected from Part A.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part A:
    Blood samples will be collected for 24 hours after the first am dose on Days 1, 3, 4 and 5 of each treatment period
    A trough sample will be collected on Day 2 (pre am dose) and on Day 6 (24 hours after morning dose on Day 5).
    Urine samples will be collected over a 24 hour period after am dose on Days 1, 3, 4 and 5.

    Part B:
    Blood samples will be collected for 24 hours after the am dose on Days 1 and 7.
    Urine samples will be collected for 24 hours after the morning dose on Days 1 and 7.
    E.5.2Secondary end point(s)
    Part A:
    • To determine the safety and tolerability of SMT C1100 and its DHD metabolites with either 1 or 2 different oral formulations of SMT C1100 in healthy adult subjects.
    • To explore the effect of intake of food in comparison to a fasting condition on the PK of SMT C1100 and its 2 DHD metabolites for either 1 or 2 different oral formulations of SMT C1100 in healthy adult subjects.
    • To investigate the diurnal variation in PK from morning versus evening dose administration of SMT C1100 and its 2 DHD metabolites, for up to 2 different oral formulations of SMT C1100 in healthy adult subjects.

    Part B:
    • To determine the diurnal variability, safety and tolerability of SMT C1100 and its DHD metabolites with a selected formulation of SMT C1100 in DMD paediatric subjects.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Part A:
    AEs continuous.
    Blood samples for serum chemistry & haematology Day -1, prior to am dose on Days 2-5 & am Day 6. Urine samples for urinalysis: screening & Days -1 & 6.
    Vital signs: Days 1-5: pre am dose, 2, 4 & 6 hours post am dose and pre pm dose, 2 & 4 hours post pm dose.
    12-lead ECGs in triplicate: Days 1, 3, 4 & 5: pre dose, 2 4 & 6 hours post dose. Continuous ECG on Days 1, 4 & 5 from 30 to 60 minutes prior to dose until 6 hours postdose. This may be extended as required for safety.

    Part B:
    AEs continuous.
    On Days 1 & 7 blood & urine samples prior to the am dose for serum chemistry, haematology & urinalysis.
    12-lead ECG in triplicate on Days 1, 2 & 7: prior to am dose & 0.5, 2, 4 & 6 hours after the am dose & prior to pm dose & 0.5, 2 & 4 after pm dose
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Trial to study the safety & PK of 2 new formulations in healthy volunteers & 1 in DMD boys
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days19
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days19
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 8
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 8
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 16
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state24
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    There will be no continued provision of the intervention for participants following the completion of this study. This is a Phase 1 study and following completion of the study the results will require analysis before it is decided whether it is appropriate to initiate further studies.
    Once the research has been completed patients will return to their standard care.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-07-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-08-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-06-28
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