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    Summary
    EudraCT Number:2016-002813-24
    Sponsor's Protocol Code Number:BAY94-8862/16538
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-09-23
    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 ConcernedGermany - BfArM
    A.2EudraCT number2016-002813-24
    A.3Full title of the trial
    Relative bioavailability study to investigate the pharmacokinetics, safety and tolerability of a single oral dose of finerenone 20 mg as suspension (pediatric formulation), intact tablet and crushed tablet (adult formulation) in the fasting condition, and to investigate the effect of a high fat, high calorie meal on the suspension in healthy male subjects in a randomized, open-label, four-fold crossover design
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase I relative bioavailability and food effect study
    A.4.1Sponsor's protocol code numberBAY94-8862/16538
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/025/2015
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBayer AG
    B.1.3.4CountryGermany
    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 supportBayer AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer AG
    B.5.2Functional name of contact pointBayer Clinical Trials Contact
    B.5.3 Address:
    B.5.3.1Street AddressN/A
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13342
    B.5.3.4CountryGermany
    B.5.4Telephone number+49 30 300139003
    B.5.6E-mailclinical-trials-contact@bayer.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBAY 94-8862 Oral suspension
    D.3.2Product code BAY 94-8862 Oral suspension
    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.3.8INN - Proposed INNFinerenone
    D.3.9.1CAS number 1050477-31-0
    D.3.9.2Current sponsor codeBAY 94-8862 micronized
    D.3.9.3Other descriptive nameBAY 94-8862
    D.3.9.4EV Substance CodeSUB30924
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3,4
    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 nameBAY 94-8862 IR tablet 20 mg
    D.3.2Product code BAY 94-8862 coated tablet 20 mg
    D.3.4Pharmaceutical form Film-coated 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 INNFinerenone
    D.3.9.1CAS number 1050477-31-0
    D.3.9.2Current sponsor codeBAY 94-8862 micronized
    D.3.9.3Other descriptive nameBAY 94-8862
    D.3.9.4EV Substance CodeSUB30924
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Diabetic kidney disease
    E.1.1.1Medical condition in easily understood language
    Treatment of patients with diabetic kidney disease
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objectives of this study are to
    •investigate the relative bioavailability of a single oral dose of 20 mg finerenone suspension and 20 mg crushed and resuspended tablet in comparison to 20 mg finerenone tablet in the fasting condition
    •investigate the effect of a high fat, high calorie meal on the pharmacokinetics after a single oral dose of 20 mg finerenone suspension
    •investigate whether 20 mg finerenone suspension and 20 mg crushed and resuspended tablet are palatable and swallowable
    E.2.2Secondary objectives of the trial
    The secondary objective of this study is to
    •investigate the safety and tolerability of single oral doses of finerenone
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.The informed consent must be signed before any study specific tests or procedures are done
    2.Healthy male subject
    3.Age: 18 to 45 years (inclusive) at the first screening examination/visit
    4.Race: White
    5.Body mass index (BMI): ≥18 and ≤29.9 kg/ m²
    6.Ability to understand and follow study-related instructions
    7.Confirmation of the subject’s health insurance coverage prior to the first screening examination/ visit
    8.Male subjects with a female partner of childbearing potential must agree to use adequate contraception when sexually active. Adequate contraception is defined as at least 2 effective methods of birth control, of which at least one is a physical barrier (e.g. condom or diaphragm or cervical cap with hormonal contraception, condom or diaphragm or cervical cap with an intrauterine device). This applies for the time period between signing of the informed consent form and 1 week after the last administration of study drug
    E.4Principal exclusion criteria
    Medical and surgical history

    1.Subjects with conspicuous findings in medical history and pre-study examination in the opinion of the investigator
    2.A history of relevant diseases of vital organs, of the central nervous system or other organs
    3.Known renal or liver insufficiency
    4.Subjects with diagnosed malignancy, psychiatric disorders, or thyroid disorders (evaluated by medical history, physical examination, clinical symptoms, and assessment of thyroid stimulating hormone at screening)
    5.Medical disorder that would impair the subject’s ability to complete the study in the opinion of the investigator
    6.Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
    7.Known hypersensitivity to the study drugs (active substances or excipients of the preparations)
    8.Known hypersensitivity to components of the American breakfast
    9.Known severe allergies, non-allergic drug reactions, or multiple drug allergies
    10.Relevant diseases within the last 4 weeks prior to the first study drug administration
    11.Febrile illness within 1 week before the first study drug administration

    Medication, drug use and special behavioral patterns

    12.Regular use of medicines
    13.Use of prohibited medicines/substances (e.g. CYP3A4 inducers, CYP3A4 inhibitors) within 2 weeks before the first study drug administration
    14.Regular use of therapeutic or recreational drugs, e.g. carnitine products, anabolics, high dose vitamins
    15.Smoking more than 10 cigarettes daily and/ or inability to refrain from smoking on the profile days until 8 h after administration
    16.Regular daily consumption of more than 500 mL of usual beer or the equivalent quantity of approximately 20 g of alcohol in another form
    17.Suspicion of drug or alcohol abuse
    18.Vegetarian or special diets preventing the subjects from eating the standard meals during the study, especially the high-fat high-calorie American breakfast or reluctance to ingest it
    19.Regular daily consumption of more than 1 L of xanthine-containing beverages
    20.Intake of foods or beverages containing grapefruit, pomelo, or Seville oranges within 2 weeks before the first study drug administration until follow-up
    21.Intake of St John’s Wort within 2 weeks before the first study drug administration until follow-up
    22.Donation of more than 100 mL of blood within 4 weeks before the first study drug administration
    23.Donation of more than 500 mL of blood within 3 months before the first study drug administration
    24.Therapies (e.g. physiotherapy, acupuncture, etc.) within 1 month before starting study treatment

    Electrocardiogram (ECG), blood pressure, heart rate

    25.Clinically relevant findings in the ECG such as a second- or third-degree atrioventricular block, prolongation of the QRS complex over 120 msec or of the QTcB-interval over 450 msec
    26.Systolic blood pressure below 100 or above 140 mmHg
    27.Diastolic blood pressure below 60 or above 90 mmHg
    28.Heart rate below 50 or above 90 beats/ min

    Physical examination

    29.Clinically relevant findings in the physical examination

    Laboratory examination

    30.Positive results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), human immunodeficiency virus antibodies (anti-HIV 1+2)
    31.Positive urine drug screening
    32.Positive alcohol breath test
    33.Clinically relevant deviations of the screened laboratory parameters in clinical chemistry, hematology, clotting status, or urinalysis from reference ranges
    E.5 End points
    E.5.1Primary end point(s)
    AUC* and Cmax of finerenone

    * AUC(0-tlast) will be used as main parameter if mean AUC(tlast-∞) >20% of AUC
    E.5.1.1Timepoint(s) of evaluation of this end point
    Blood sampling for finerenone will be performed from pre-dose up to 24 hours after drug administration in each treatment period
    E.5.2Secondary end point(s)
    N/A
    E.5.2.1Timepoint(s) of evaluation of this end point
    N/A
    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
    Phase I study in healthy male subjects
    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 Yes
    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
    Single-center, randomized, open-label, four-fold crossover design
    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 trial4
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    The end of the study as a whole will be the date when the clean database is available.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days
    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: 16
    F.1.3Elderly (>=65 years) No
    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 No
    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 state16
    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)
    After the end of this study, further treatment is not necessary since only healthy subjects will be included in the study.
    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 Decision2016-11-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-03-01
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