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    The EU Clinical Trials Register currently displays   43841   clinical trials with a EudraCT protocol, of which   7281   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).

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    Summary
    EudraCT Number:2021-006712-93
    Sponsor's Protocol Code Number:MK-1088-002
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-04-22
    Trial 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 ConcernedDenmark - DHMA
    A.2EudraCT number2021-006712-93
    A.3Full title of the trial
    A Phase 1/Phase 2 Study to Evaluate the Safety and Tolerability of MK-1088 as Monotherapy and in Combination with Pembrolizumab in Participants with Advanced Solid Tumors
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 1/Phase 2 Study to Evaluate the Safety and Tolerability of MK-1088 as Monotherapy/ single agent and in Combination with Pembrolizumab in Participants with Advanced Solid Tumors
    A.4.1Sponsor's protocol code numberMK-1088-002
    A.5.4Other Identifiers
    Name:INDNumber:160204
    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 SponsorMerck Sharp & Dohme LLC
    B.1.3.4CountryUnited States
    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 supportMerck Sharp & Dohme LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMK-1088
    D.3.2Product code MK-1088
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot applicable
    D.3.9.2Current sponsor codeMK-1088
    D.3.9.3Other descriptive nameMK-1088
    D.3.9.4EV Substance CodeSUB218695
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMK-1088
    D.3.2Product code MK-1088
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot applicable
    D.3.9.2Current sponsor codeMK-1088
    D.3.9.3Other descriptive nameMK-1088
    D.3.9.4EV Substance CodeSUB218695
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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: 3
    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 Yes
    D.2.1.1.1Trade name KEYTRUDA® (Pembrolizumab, MK-3475)
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code MK-3475
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPembrolizumab
    D.3.9.1CAS number 1374853-91-4
    D.3.9.2Current sponsor codeMK-3475
    D.3.9.4EV Substance CodeSUB167136
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Advanced/metastatic solid tumors
    E.1.1.1Medical condition in easily understood language
    Advanced Solid Tumors/ Cancers
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10065252
    E.1.2Term Solid tumor
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To determine the safety and tolerability and to establish a preliminary maximum tolerated dose/recommended Phase 2 dose of MK-1088 administered as monotherapy and in combination with pembrolizumab infusion in Part 1
    E.2.2Secondary objectives of the trial
    1. To evaluate the PK of MK-1088 administered as monotherapy and in combination with pembrolizumab infusion in Part 1 and in Part 2.
    2. To evaluate the anti-tumor activity (objective response rate [ORR] based on PCWG-modified RECIST 1.1 [prostate cancer participants only] or RECIST 1.1 [all other participants]) of MK-1088 as assessed by the investigator when used as monotherapy and in combination with pembrolizumab in Part 1 and in Part 2.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.The participant must have a histologically- or cytologically-confirmed diagnosis of advanced/metastatic solid tumor by pathology report and have received, have been intolerant to, or have been ineligible for treatment known to confer clinical benefit
    For metastatic castrate-resistant prostate cancer only:
    •Must have previously received docetaxel, prior treatment with one other chemotherapy is allowed as well as up to 2 second-generation hormonal manipulations
    •Have prostate cancer progression within 6 months before to screening, as determined by the investigator:
    a.PSA progression using local laboratory values as defined by a minimum of 2 rising PSA levels with an interval of ≥1 week between each assessment where the PSA value at screening should be ≥2 ng/mL
    b.Radiographic disease progression in soft tissue based on PCWG-modified RECIST 1.1 or RECIST 1.1 criteria with or without PSA progression
    c.Radiographic disease progression in bone defined as the appearance of 2 or more new bone lesions on bone scan with or without PSA progression
    2.Disease per PCWG-modified RECIST 1.1 for mCRPC or measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology. Target lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions
    For participants with metastatic castrate-resistant prostate cancer:
    a.Have PCWG-modified RECIST 1.1 measurable prostate cancer on CT or MRI scans as assessed by the local site/investigator/radiology
    OR
    b.Detectable bone metastases by whole body bone scintigraphy as per PCWG guidance
    3.Is male or female, from minimum of 18 years of age inclusive, at the time of providing informed consent
    4.If male, agrees to the following during the intervention period and for at least 7 days after the last dose of MK-1088:
    •Abstains from heterosexual intercourse as their preferred and usual lifestyle and agrees to remain abstinent
    OR
    •Uses contraception unless confirmed to be azoospermic as detailed below:
    -Uses a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a WOCBP who is not currently pregnant
    -Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
    5.A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
    •Not a WOCBP
    OR
    •A WOCBP and:
    -Uses a contraceptive method that is highly effective, with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle,during the intervention period and for at least 7 days after the last dose of MK-1088 and for at least 120 days after the last dose of pembrolizumab, whichever occurs last after the last dose of study intervention
    -Has a negative highly sensitive pregnancy test within 24 hours before the first dose of study intervention. If a urine test cannot be confirmed as negative, a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive
    -Abstains from breastfeeding during the study intervention period and for at least 7 days after study intervention with MK-1088 or 120 days from the last dose of pembrolizumab
    -Medical history, menstrual history, and recent sexual activity has been reviewed by the investigator
    6.The participant has provided documented informed consent/assent for the study
    7.Archival tumor tissue sample or newly obtained core needle biopsy of a tumor lesion not previously irradiated has been provided
    8.Specimens must be collected within 72 hours before the start of study intervention
    9.Have an ECOG Performance Status of 0 to 1 assessed within 72 hours prior to the first dose of study intervention
    10.HIV-infected participants must have well controlled HIV on ART, defined as:
    a.Participants on ART must have a CD4+ T-cell count >350 cells/mm3 at the time of screening
    b.Participants on ART must have achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 or the LLOQ using the locally available assay at the time of screening and for at least 12 weeks before screening
    c.Participants on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before study entry
    d.The combination ART regimen must not contain any antiretroviral medications other than: abacavir, dolutegravir, emtricitabine, lamivudine, raltegravir, rilpivirine, or tenoforvir
    11.Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load before to treatment allocation
    12.Participants with history of HCV infection are eligible if HCV viral load is undetectable at screening
    13.Be able to swallow and retain oral medication


    E.4Principal exclusion criteria
    1.Has had chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks before the first dose of study intervention, or has not recovered to CTCAE Grade 1 or better from any AEs that were due to cancer therapeutics administered more than 4 weeks earlier
    2.Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years
    3.Has clinically active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain or meningeal metastases may participate and be eligible for treatment provided they are stable and asymptomatic, have no evidence of new or enlarging brain metastases, are evaluated within 4 weeks before first study intervention administration, and are off immunosuppressive doses of systemic steroids at least 2 weeks before enrollment
    4.Has had a severe hypersensitivity reaction to treatment with a monoclonal antibody/components of the study intervention
    5.Has an active infection requiring therapy
    6.Has a history of interstitial lung disease
    7.Has a history of pneumonitis that required steroids or current pneumonitis
    8.Has an active autoimmune disease that has required systemic treatment in the past 2 years
    9.Has concurrent active Hepatitis B and Hepatitis C virus infection
    10.HIV-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease
    11.Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant’s participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator
    12.Has known psychiatric or substance abuse disorders that would interfere with the participant’s ability to cooperate with the requirements of the study
    13.Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through the duration of contraception after the last dose of study intervention
    14.Has not fully recovered from any effects of major surgery without significant detectable infection. Surgeries that required general anesthesia must be completed at least 2 weeks before first study intervention administration. Surgery requiring regional/epidural anesthesia must be completed at least 72 hours before first study intervention administration and participants should be recovered
    15.Has a history or current evidence of a GI condition or impaired liver function or diseases that in the opinion of the investigator may significantly alter the absorption or metabolism of oral medications; any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant’s participation for the full duration of the study, make administration of the study drugs hazardous, or make it difficult to monitor adverse effects such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator
    16. Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including NYHA Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability. Note: Medically controlled arrhythmia would be permitted.
    17. Has a QTcF>470 msec.
    18. History of an allogeneic stem cell transplant or solid organ transplant.
    19. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor, AND was discontinued from that treatment due to a Grade 3 or higher irAE
    20.Has received prior A2A or A2B receptor antagonist therapy
    21.Currently receiving strong/moderate CYP3A4 inducers or inhibitors
    22.Currently receiving H2 blockers or proton-pump inhibitors
    23.Has received prior systemic anticancer therapy including investigational agents within 4 weeks before allocation
    24.Has received prior radiotherapy within 2 weeks of start of study intervention.
    25.Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed. Refer to the protocol for information on COVID-19 vaccines
    26. Has received an investigational agent or has used an investigational device within 4 weeks prior to intervention administration
    27.Has a “superscan” bone scan. This is defined as an intense symmetric activity in the bones and diminished renal parenchymal activity on screening bone scan such that the presence of additional metastases in the future could not be evaluated
    28. Has not adequately recovered from major surgery or has ongoing surgical complications.
    E.5 End points
    E.5.1Primary end point(s)
    1. Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
    2. Number of Participants Experiencing Adverse Events (AEs)
    3. Number of Participants Discontinuing Study Treatment Due to AEs
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Up to ~21 days
    2. Up to ~27 months
    3. Up to ~24 months
    E.5.2Secondary end point(s)
    1. Area Under the Plasma Concentration-Time Curve (AUC) of MK-1088
    2. Maximum Plasma Concentration (Cmax) of MK-1088
    3. Minimum Plasma Concentration (Cmin) of MK-1088
    4. Objective Response Rate (ORR)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Pre-dose, 1, 2, 4, 8 hours post-dose on Cycle 1 Day 1, Cycle 2 Day 1; Pre-dose on Cycle 1 Day 2, Cycle 2 Day 2; Pre-dose on Cycles 3, 4 and every 4 cycles (up to ~27 months); Cycle = 21 days
    2. Pre-dose, 1, 2, 4, 8 hours post-dose on Cycle 1 Day 1, Cycle 2 Day 1; Pre-dose on Cycle 1 Day 2, Cycle 2 Day 2; Pre-dose on Cycles 3, 4 and every 4 cycles (up to ~27 months); Cycle = 21 days
    3. Pre-dose, 1, 2, 4, 8 hours post-dose on Cycle 1 Day 1, Cycle 2 Day 1; Pre-dose on Cycle 1 Day 2, Cycle 2 Day 2; Pre-dose on Cycles 3, 4 and every 4 cycles (up to ~27 months); Cycle = 21 days
    4. Up to ~36 months
    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 Yes
    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
    First administration in oncology patients
    E.7.2Therapeutic exploratory (Phase II) Yes
    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 Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Part 1: dose escalation and confirmation: Part 2: cohort expansion
    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.8.2.4Number of treatment arms in the trial2
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Israel
    United States
    Switzerland
    Denmark
    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 years3
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 32
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 48
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 15
    F.4.2.2In the whole clinical trial 80
    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)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-06-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-02
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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