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    Summary
    EudraCT Number:2019-000938-20
    Sponsor's Protocol Code Number:2019-5172
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-04-08
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2019-000938-20
    A.3Full title of the trial
    Pharmacokinetic study of minocycline in patients with pulmonary nontuberculous mycobacterial disease
    Farmacokinetisch onderzoek naar minocycline in patienten met pulmonale nontuberculeuze mycobacteriele infecties
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Minocycline use in pulmonary infections with mycobacterium avium complex
    Onderzoek naar minocycline gebruik in longinfecties met M.avium complex
    A.3.2Name or abbreviated title of the trial where available
    MINO PK in NTM
    MINO FK in NTM
    A.4.1Sponsor's protocol code number2019-5172
    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 SponsorRadboudumc
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportRadboudumc
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRadboudumc
    B.5.2Functional name of contact pointMicrobiology
    B.5.3 Address:
    B.5.3.1Street AddressGeert Grooteplein Zuid 10
    B.5.3.2Town/ cityNijmegen
    B.5.3.3Post code6525GA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310243614356
    B.5.6E-mailJakko.vanIngen@radboudumc.nl
    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 Yes
    D.2.1.1.1Trade name Minocycline
    D.2.1.1.2Name of the Marketing Authorisation holderSandoz B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameMinocycline
    D.3.2Product code RVG 22156
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    Pulmonary disease caused by Mycobacterium avium complex. Mycobacterium avium complex is a nontuberculous mycobacterium.
    Longziekten veroorzaakt door Mycobacterium avium complex. Mycobacterium avium complex is een nontuberculeuze mycobacterium.
    E.1.1.1Medical condition in easily understood language
    Lunginfections with Mycobacterium avium complex, which is a bacteria that can cause lung diseases.
    Longinfecties met Mycobacterium avium complex, welke een bacterie is die longziekten kan veroorzaken.
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To describe the pharmacokinetics of a single dose of minocycline in patients with M. avium complex pulmonary disease.
    Het beschrijven van de farmacokinetiek van een enkele dosis minocycline in patiënten met M. avium complex longziekte.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of rifampicin on the pharmacokinetics of a single dose of minocycline in patients with MAC-PD.
    Het evalueren van het effect van rifampicine op de farmacokinetiek van een enkele dosis van minocycline in patiënten met MAC-PD.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - ATS diagnostic criteria for NTM-PD are met, i.e. the patient is symptomatic, has nodules, bronchiectasis or fibro-cavitary lesions seen on (HR)CT scan of the lungs and ≥2 positive sputum cultures or one positive BAL culture of the same M. avium complex species.
    - The subject is eligible to start the guideline-recommended rifampicin-based regimen according to the treating physician.
    - At least one of the positive cultures must be done in the last 4 months before inclusion.
    - Age ≥ 18 years.
    - Signed and dated patient informed consent.
    - ATS diagnose criteria voor NTM-PD zijn behaald, patiënt is symptomatisch, heeft nodulen, bronchiëctasie of fibro-cavitaire laesies te zien bij (HR) CT-scan van de longen en ≥ 2 positieve sputumkweken of één positieve BAL-cultuur van dezelfde M avium-complexe soorten.
    - Het subject kan volgens de behandelend arts het door de richtlijn aanbevolen op rifampicine gebaseerde regime starten.
    - Ten minste één van de positieve culturen moet in de laatste 4 maanden vóór opname worden gedaan.
    - Leeftijd >18 jaar
    E.4Principal exclusion criteria
    - A relevant medical history or current condition that might interfere with drug absorption, distribution, metabolism or excretion (i.e. chronic gastro-intestinal disease, renal or hepatic disease).
    - Diagnosed with cystic fibrosis (as this may affect the pharmacokinetics of drugs).
    - Pregnant or breastfeeding (contra-indications for minocycline) or inadequate contraceptive measures (in view of the administration of rifampicin which interacts with oral contraceptive drugs).
    - Use of drugs that cause a relevant drug interaction with minocycline, i.e. oral magnesium, bismuth, aluminium, calcium, zinc or iron containing formulations (antacid drugs, multivitamin and mineral-containing drugs) and other drugs besides rifampicin that induce metabolic enzymes, including but not limited to barbiturates, carbamazepin and phenytoin. The investigators refer to the ‘Flockhart’table for check of presence of possible inducers (https://drug-interactions.medicine.iu.edu/Main-Table.aspx).
    - ALAT > 3 times the upper limit of normal (normal <45 U/l).
    - ASAT > 3 times the upper limit of normal (normal <35 U/l).
    - An abnormal serum creatinine level (defined as a level that is higher than the upper limit of normal, i.e. >110 umol/l).
    - Active alcohol abuse.
    - Hypersensitivity to minocycline or to other tetracycline antibiotics.
    - Een relevante medische geschiedenis of huidige aandoening die de absorptie, distributie, metabolisme of uitscheiding van het geneesmiddel zou kunnen verstoren (zoals chronische gastro-intestinale aandoeningen, nier- of leverziekte).
    - Gediagnosticeerd met cystic fibrosis (omdat dit de farmacokinetiek van geneesmiddelen kan beïnvloeden).
    - Zwanger of borstvoeding (contra-indicaties voor minocycline) of ontoereikende anticonceptiemaatregelen (gezien de toediening van rifampicine welke een interactie hebben met orale anticonceptiva)
    - Gebruik van geneesmiddelen die een relevante geneesmiddelinteractie veroorzaken met minocycline, dwz orale magnesium-, bismut-, aluminium-, calcium-, zink- of ijzerbevattende formuleringen (antacidumgeneesmiddelen, multivitaminen en mineraalbevattende geneesmiddelen) en andere geneesmiddelen naast rifampicine die metabole enzymen induceren, inclusief maar niet beperkt tot barbituraten, carbamazepine en fenytoïne. De onderzoekers verwijzen naar de 'Flockhart'-tabel voor controle van de aanwezigheid van mogelijke inductoren (https://drug-interactions.medicine.iu.edu/Main-Table.aspx).
    - ALAT> 3 maal de bovengrens van normaal (normaal <45 U / l).
    - ASAT> 3 keer de bovengrens van normaal (normaal <35 U / l).
    - Een abnormaal serumcreatininegehalte (gedefinieerd als een niveau dat hoger is dan de bovengrens van normaal, d.w.z.> 110 umol / l).
    - Actief alcoholmisbruik.
    - Overgevoeligheid voor minocycline of voor andere tetracycline-antibiotica.
    E.5 End points
    E.5.1Primary end point(s)
    Total exposure (area under the concentration versus time curve from T=0 up to infinity, after a single dose of minocycline, AUC0-∞) and peak serum concentration (Cmax) of minocycline before and after start of a rifampicin containing regimen.
    Totale blootstelling (oppervlakte onder de concentratie versus tijd curve van t=0 tot oneindig, na een enkele dosis minocycline, AUC0-∞) en piek serum concentraties (Cmax) van minocycline voor en na de start van de rifampicine gebaseerde behandeling.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Blood is taken before and after both single doses of minocycline. Blood is taken for pharmacokinetic sampling at t=0 (before minocycline intake), 1, 2, 3, 4, 8, 24, 48 hours. Pharmacokinetic parameters are calculated by applying standard noncompartmental pharmacokinetic data analyses.
    Er wordt bloed afgenomen voor en na beide enkele dosissen van minocyline. Bloed wordt afgenomen voor farmacokinetische metingen op t=0 (voor inname van minocycline), 1, 2, 3, 4, 8, 24, 48 uur. Farmacokinetische parameters worden berekend door het toepassen van standaard noncompartementele farmacokinetische data analyse.
    E.5.2Secondary end point(s)
    - Other pharmacokinetic parameters of minocycline, i.e. clearance, volume of distribution and half-life to the given dosage before and after start of a rifampicin containing regimen
    - Pharmacokinetic parameters of rifampicin.
    - A population PK model of minocycline suitable for dosing regimen simulations
    - Andere farmacokinetische parameters van minocycline, zoals klaring, distributievolume en halfwaardetijd tot de gegeven dosering voor en na aanvang van de rifampicine gebaseerde behandeling.
    - Farmacokinetische parameters van rifampicine.
    - Een populatie-PK-model van minocycline dat geschikt is voor het doseren van regimesimulaties
    E.5.2.1Timepoint(s) of evaluation of this end point
    Blood is taken before and after both single doses of minocycline. Blood is taken for pharmacokinetic sampling at t=0 (before minocycline intake), 1, 2, 3, 4, 8, 24, 48 hours. Pharmacokinetic parameters are calculated by applying standard noncompartmental pharmacokinetic data analyses.
    Er wordt bloed afgenomen voor en na beide enkele dosissen van minocyline. Bloed wordt afgenomen voor farmacokinetische metingen op t=0 (voor inname van minocycline), 1, 2, 3, 4, 8, 24, 48 uur. Farmacokinetische parameters worden berekend door het toepassen van standaard noncompartementele farmacokinetische data analyse.
    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 No
    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 No
    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
    Pharmacokinetic study of minocycline in M. avium complex pulmonary disease patients
    Farmacokinetiek van minocycline in M. avium complex longziekte
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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
    Open label, één-arm, twee-periode, farmacokinetisch onderzoek met vaste orde
    Open label, one-arm, two-period, fixed-order pharmacokinetic study
    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 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 is defined as the last patient’s last visit.
    Het einde van de studie is gedefinieerd als de laatste patient zijn/haar laatste bezoek.
    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 months8
    E.8.9.1In the Member State concerned 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: 8
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 7
    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 state12
    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, normal treatment for M. avium complex pulmonary disease continues in normal way.
    Niets, de normale behandeling voor M. avium complexe longziekte gaat op gebruikelijke manier door.
    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 Decision2021-04-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-07
    P. End of Trial
    P.End of Trial StatusOngoing
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