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    Summary
    EudraCT Number:2015-003799-63
    Sponsor's Protocol Code Number:BAY1193397/17500
    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:2017-02-13
    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 number2015-003799-63
    A.3Full title of the trial
    A randomized, single blind, threefold crossover, single center study to assess the safety and the effects of 1 mg and 5 mg BAY 1193397 in comparison to placebo on skin capillary blood flow and transcutaneous oxygen pressure after single dose in type II diabetic patients.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    It is the aim of this study to analyse the blood flow in small blood vessels (capillaries) in diabetic patients before and after two different single doses of BAY 1193397 (1 mg and 5 mg tablets) and placebo. In order to see if the study drug is effective, BAY 1193397 tablets will be compared to placebo tablets.
    A.3.2Name or abbreviated title of the trial where available
    The effects of BAY 1193397 on skin capillary blood flow
    A.4.1Sponsor's protocol code numberBAY1193397/17500
    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 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 pointEarly Clinical Lead (ECL)
    B.5.3 Address:
    B.5.3.1Street AddressAprather Weg 18a, G429, R124
    B.5.3.2Town/ cityWuppertal, Elberfeld
    B.5.3.3Post code42113
    B.5.3.4CountryGermany
    B.5.4Telephone number0049202364272
    B.5.6E-mailchristiane.otto@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 1193397 1 mg immediate release (IR) tablets
    D.3.2Product code BAY 1193397 1 mg immediate release (IR) tablets
    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 yet assigned
    D.3.9.2Current sponsor codeBAY 1193397
    D.3.9.3Other descriptive nameBAY 1193397
    D.3.9.4EV Substance CodeSUB169672
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment of diabetic foot ulcer
    E.1.1.1Medical condition in easily understood language
    Treatment of diabetic foot ulcer
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10012684
    E.1.2Term Diabetic peripheral vascular disease
    E.1.2System Organ Class 100000004866
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Investigate the changes in resting blood flow speed in skin capillaries before and after study drug administration.

    Investigate the change in peak capillary blood flow speed during a temporary increase in blood flow (reactive hyperemia) before and after study drug administration.

    Investigate the change in time to peak capillary blood flow speed during a temporary increase in blood flow (reactive hyperemia) before and after study drug administration.

    Investigate the change in oxygen pressure through the skin before and after study drug administration
    E.2.2Secondary objectives of the trial
    Analyse the safety and tolerability of BAY 1193397 after a single dose administration as evidenced by the incidence and severity of adverse events
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The informed consent must be signed before any study specific tests or procedures are done (patient must be able to give informed consent, no legal representative allowed)
    - Patients with a diagnosis of type II diabetes mellitus and PAD and/or microangiopathy as evidenced by at least one of the following criteria:
    a) TBPI < 0.7 at screening
    b) ischaemic or neuro-ischaemic DFU in medical history (verified by medical records)
    c) clinical diagnosis of PAD in medical history (verified by medical records)
    d) diagnosis of nephropathy that is most likely due to diabetes mellitus type II
    e) diagnosis of diabetic retinopathy
    f) diagnosis of diabetic polyneuropathy
    - Age 55 to 75 years (inclusive) at the screening visit
    - Non-smokers are preferred for inclusion in this study. If smokers are included, they must refrain from smoking on the days of treatment periods 1, 2, and 3 until all examinations have been performed
    - Patients are expected to be on stable medication during study conduct. No planned changes in drug therapy during active treatment period of the study (i.e. from treatment period 1 to treatment period 3) is allowed
    - Men or confirmed postmenopausal women (defined as exhibiting spontaneous amenorrhea for at least 12 months before screening or as exhibiting spontaneous amenorrhea for 6 months before screening with documented serum follicle-stimulating hormone [FSH] levels > 40 mIU/mL) or women without childbearing potential based on surgical treatment 6 weeks before screening such as bilateral tubal ligation, bilateral oophorectomy with or without hysterectomy (documented by medical report verification). Male patients, who are sexually active and have not been surgically sterilized must agree to use two reliable and acceptable methods of contraception simultaneously (one method used by the study patient and one method used by the partner) during the study and for 12 weeks after receiving the investigational medicinal product and not to act as sperm donor for 12 weeks after dosing. Acceptable methods of contraception include for example: a) condoms (male or female) with or without a spermicidal agent b) diaphragm or cervical cap with spermicide c) intrauterine device d) hormone-based contraception
    - Ability to understand and follow study related instructions
    E.4Principal exclusion criteria
    Medical and surgical history
    - Patients with existing lower limb ulcers
    - Patients with nailfold capillaries at the great toe that are technically difficult to assess
    - Patients suffering from PAD Fontaine Stage 4
    - Patients requiring planned revascularization
    - Patients suffering from diseases other than diabetes mellitus that are known to lead to disturbances in skin microcirculation or interfering with the method of measurement such as Raynaud’s disease, collagen vascular disorders , atopic dermatitis, psoriasis
    - Patients with diabetes mellitus induced by immunosuppressive treatment
    - Patients with renal replacement therapy
    - Patients with organ transplants
    - Medical history of autoimmune disease
    - Myocardial infarction, acute coronary syndrome, transient ischemic attack (TIA),
    stroke, revascularization, angioplasty within 3 months prior to randomization
    - Any planned surgical intervention during the course of the study
    - Medical condition or history thereof or any deviation from normal laboratory values that in the opinion of the investigator would impair the ability to complete the planned study procedures
    - Any surgical or medical condition which significantly alters absorption, distribution, metabolism or excretion of study drugs, including, but not limited to: history of major gastrointestinal (GI) tract surgery, inflammatory bowel disease, currently active gastritis, pancreatitis, treatment with cholestyramine and colestipol resins
    - Patients with HbA1c > 12% (> 108 mmol/mol) at the screening visit
    - Any other condition or therapy, which would make the subject unsuitable for this study and will not allow participation for the full planned study period (e.g. active malignancy or other condition limiting life expectancy to less than 12 months)

    Medication, drug use and special behavioral patterns
    - Use of alpha or beta AR agonists
    - Use of alpha AR antagonists
    - Use of serotonin/norepinephrine reuptake inhibitors (SNRIs)
    - Use of tricyclic antidepressants at a dose equivalent of more than 50 mg amitryptyline
    - Use of strong CYP 3A4 inhibitors (as specified in the study protocol) within 7 days prior to first administration and until follow-up. Topical use of antifungal cream is allowed.
    - Use of strong CYP 3A4 inducers (as specified in the study protocol) within 7 days prior to first administration and until follow up Consumption of grapefruit (juice or fruit) within 7 days prior to first administration and until follow-up
    - Use of St John´s wort within 7 days prior to first administration and until follow-up
    - Suspicion of drug or alcohol abuse
    - Donation of more than 100 / 500 mL of blood within 4 weeks / 3 months prior to screening
    - Known hypersensitivity to the study drugs (active substances or excipients of the preparations)
    - No pedicure or nail polish is allowed from screening until the end of the active study period (end of treatment period 3)

    ECG, blood pressure, heart rate

    - Clinically relevant findings in the ECG, such as a second- (type Mobitz II) or thirddegree AV block, or QTc elevation as follows:
    - > 450 msec in patients without a complete bundle branch block
    - > 480 msec in patients with a complete bundle branch block
    - > 500 msec in patients with a right ventricular paced rhythm
    - Systolic blood pressure below 100 mmHg or above 180 mmHg at the screening visit based on the average of three readings taken from the arm with the highest systolic recordings
    - Diastolic blood pressure below 50 or above 110 mmHg at the screening visit based on the average of three readings taken from the arm with the highest systolic recordings
    - Heart rate below 50 or above 100 beats/min at screening (obtained from ECG)

    Physical examination
    - Clinically relevant findings in the physical examination which, in the opinion of the investigator, preclude participation for reasons of the patient’s safety

    Laboratory examination
    - Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2 using the Modification of Diet in Renal Disease (MDRD) formula at screening
    - Anemia as evidenced by hemoglobin values < 10 mg/dL at screening
    - Hepatic impairment as evidenced by aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or gamma-glutamyl transpeptidase (GGT) threefold above upper limit of normal (ULN) and, in addition, bilirubin twofold above ULN

    Other

    - Previous assignment to treatment during the study
    - Previous (within 30 days or 5 half-lives prior to screening, whichever is longer) or concomitant participation in another clinical study with investigational medicinal product(s)
    - Close affiliation with the investigational site; e.g. a close relative of the investigator, dependent person (e.g. employee or student of the investigational site)
    - Patient is in custody by order of an authority or court of law
    E.5 End points
    E.5.1Primary end point(s)
    Change in resting CBV (capillary blood flow velocity) (= resting CBV after study drug administration – resting CBV before study drug administration)
    - Change in peak CBV during reactive hyperemia (= peak CBV after study drug administration – peak CBV before study drug administration)
    - Change in time to peak CBV during reactive hyperemia (= time to peak CBV after study drug administration – time to peak CBV before study drug administration)
    - Change in foot TcPO2 (transcutaneous oxygen pressure) (= TcPO2 after study drug administration – TcPO2 before study drug administration)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 hour after administration of study drug at visits 2,3,4
    E.5.2Secondary end point(s)
    Incidence and severity of adverse events
    E.5.2.1Timepoint(s) of evaluation of this end point
    After administration of study drug at visits 2,3,4
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days17
    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: 22
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 22
    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 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 state22
    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, patients will continue receiving standard of care at the discretion of their primary physician.
    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 Decision2017-03-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-10-28
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