Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:11 PM
Study NCT ID:
NCT05861258
Status:
TERMINATED
Last Update Posted:
2025-06-29
First Post:
2023-05-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Study of Minocycline in Patients With Pulmonary Nontuberculous Mycobacterial Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C562573', 'term': 'cyclopia sequence'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008911', 'term': 'Minocycline'}], 'ancestors': [{'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'A single group, two-period, fixed-order pharmacokinetic study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'whyStopped': 'The trial was terminated prematurely after the enrollment of 12 out of 15 planned subjects, due to a lack of personnel and no option to continue study measurements.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-05-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-25', 'studyFirstSubmitDate': '2023-05-04', 'studyFirstSubmitQcDate': '2023-05-15', 'lastUpdatePostDateStruct': {'date': '2025-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic parameters of minocycline in MAC-PD patients without concurrent use of rifampicin.', 'timeFrame': 'Day 5 of the first minocycline dosing period', 'description': 'The area under the curve (AUC0-24h)'}, {'measure': 'Pharmacokinetic parameters of minocycline in MAC-PD patients without concurrent use of rifampicin.', 'timeFrame': 'Day 5 of the first minocycline dosing period', 'description': 'The peak plasma concentration (Cmax)'}, {'measure': 'Pharmacokinetic parameters of minocycline in MAC-PD patients without concurrent use of rifampicin.', 'timeFrame': 'Day 5 of the first minocycline dosing period', 'description': 'The plasma trough concentration (Cmin)'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic parameters of minocycline in MAC-PD patients with concurrent use of rifampicin.', 'timeFrame': 'Day 5 of the second minocycline dosing period', 'description': 'The area under the curve (AUC0-24h)'}, {'measure': 'Pharmacokinetic parameters of minocycline in MAC-PD patients with concurrent use of rifampicin.', 'timeFrame': 'Day 5 of the second minocycline dosing period', 'description': 'The peak plasma concentration (Cmax)'}, {'measure': 'Pharmacokinetic parameters of minocycline in MAC-PD patients with concurrent use of rifampicin.', 'timeFrame': 'Day 5 of the second minocycline dosing period', 'description': 'The plasma trough concentration (Cmin)'}, {'measure': 'Pharmacokinetic parameters of rifampicin in MAC-PD patients', 'timeFrame': 'Day 5 of the second minocycline dosing period', 'description': 'The peak plasma concentration (Cmax)'}, {'measure': 'Adverse Events', 'timeFrame': 'Through study completion, an average of 6 weeks', 'description': "The number of (participants with) adverse events will be measured. Adverse events will be graded according to the 'Common Terminology Criteria for Adverse Events' (CTCAE)"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pharmacokinetics', 'Minocycline', 'Rifampicin'], 'conditions': ['Mycobacterium Avium Complex Pulmonary Disease']}, 'referencesModule': {'references': [{'pmid': '32636299', 'type': 'BACKGROUND', 'citation': 'Daley CL, Iaccarino JM, Lange C, Cambau E, Wallace RJ Jr, Andrejak C, Bottger EC, Brozek J, Griffith DE, Guglielmetti L, Huitt GA, Knight SL, Leitman P, Marras TK, Olivier KN, Santin M, Stout JE, Tortoli E, van Ingen J, Wagner D, Winthrop KL. Treatment of nontuberculous mycobacterial pulmonary disease: an official ATS/ERS/ESCMID/IDSA clinical practice guideline. Eur Respir J. 2020 Jul 7;56(1):2000535. doi: 10.1183/13993003.00535-2020. Print 2020 Jul.'}]}, 'descriptionModule': {'briefSummary': 'Antimycobacterial treatment of M. avium complex pulmonary disease (MAC-PD) has suboptimal cure rates and is challenging due to frequent adverse drug reactions and drug-drug interactions. Hence, there is an urgent need for improved treatment regimens with effective and tolerable antibiotics.\n\nMinocycline is a well-tolerated, orally administered tetracycline-type antibiotic with in vitro activity against MAC, but pharmacokinetic data in the target population is lacking. Moreover, rifampicin, a strong inducer of cytochrome P450 enzymes involved in drug metabolism and of various drug transporters, is part of the current first-line MAC-PD treatment regimen and has a substantial interaction with doxycycline, a related tetracycline.\n\nPharmacokinetic data in the target population will allow us to propose an appropriate dose of minocycline when co-administered with or without rifampicin\n\nMino-PK is an open label, one-arm, two-period, fixed-order pharmacokinetic study that will assess exposure to minocycline in MAC-PD patients with and without concurrent use of rifampicin. Subjects will receive two 5-day dosing periods of minocycline; the first without and second with concurrent use of rifampicin. Minocycline plasma concentrations will be determined after both dosing periods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 2020 guideline (ATS/ERS/ESCMID/IDSA) diagnostic criteria for nontuberculous mycobacterial pulmonary disease 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 bronchoalveolar lavage culture of the same M. avium complex species.\n* At least one of the positive cultures must be done in the last 4 months before inclusion.\n* The subject is eligible to start the guideline-recommended rifampicin-based regimen according to the treating physician.\n* Age ≥ 18 years.\n* Signed and dated patient informed consent.\n\nExclusion Criteria:\n\n* 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).\n* Diagnosed with cystic fibrosis (as this may affect the pharmacokinetics of drugs).\n* Pregnant or breastfeeding (contra-indications for minocycline) or inadequate contraceptive measures (in view of the administration of rifampicin which interacts with oral contraceptive drugs, adequate contraceptive measures are abstinence from sexual activities and barrier methods).\n* 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 and drugs besides rifampicin that are strong inducers of metabolic enzymes, including barbiturates, carbamazepin and phenytoin (as judged by the investigators).\n* ALAT \\> 3 times the upper limit of normal (normal \\<45 U/l).\n* ASAT \\> 3 times the upper limit of normal (normal \\<35 U/l).\n* An abnormal serum creatinine level (defined as a level that is higher than the upper limit of normal, i.e. \\>110 umol/l).\n* Active alcohol abuse.\n* Hypersensitivity to minocycline or to other tetracycline antibiotics.'}, 'identificationModule': {'nctId': 'NCT05861258', 'acronym': 'Mino-PK', 'briefTitle': 'Pharmacokinetic Study of Minocycline in Patients With Pulmonary Nontuberculous Mycobacterial Disease', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'Pharmacokinetic Study of Minocycline in Patients With Pulmonary Nontuberculous Mycobacterial Disease', 'orgStudyIdInfo': {'id': 'NL69313.091.19'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Minocycline', 'type': 'DRUG', 'description': 'Patients with M. avium complex pulmonary disease will receive 200 mg of minocycline for 5 days before starting rifampicin and after 1 month (±1 week) of receiving rifampicin. Antimycobacterial drugs other than rifampicin can be started prior to or simultaneous with the first minocycline dosing period as part of standard care. At day 5 of both minocycline dosing periods, blood will be sampled for minocycline plasma concentration measurements at T = 0, 1, 2, 3, 4, 6, 8 and 24 hours.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '6525 GA', 'city': 'Nijmegen', 'state': 'Gelderland', 'country': 'Netherlands', 'facility': 'Radboud University Medical Center', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}], 'overallOfficials': [{'name': 'Wouter Hoefsloot, MSc, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radboud University Medical Center'}]}, 'ipdSharingStatementModule': {'url': 'https://data.ru.nl/?0', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': 'Data will become available for 15 years after the first study report has been published.', 'ipdSharing': 'YES', 'description': 'The pseudonymized participant data will be accessible in the Radboud Data Repository under restricted access, only if the participant has provided consent. Requests for access will be checked, by a data access committee (DAC) formed by the sponsor (i.e. PI and other research members / coordinators)\n\nThe following data will be shared:\n\n* Final versions of data used for analysis\n* Documentation/codebooks necessary for understanding the data\n* The .xml file that contains the full structure of the eCRF build in Castor EDC\n* Read me.txt for understanding the structure and content of the documents', 'accessCriteria': 'To be determined'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}