Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-02-27 @ 7:36 AM
Study NCT ID:
NCT02444234
Status:
COMPLETED
Last Update Posted:
2020-06-02
First Post:
2015-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pharmacokinetics of Tedizolid Phosphate in Cystic Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'beringer@usc.edu', 'phone': '323-442-1402', 'title': 'Paul M Beringer, Pharm.D.', 'organization': 'University of Southern California'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Observed a large interindividual variability in the absorption rate constant. Due to difficulty of producing sputum, sputum samples were sparse. Did not include a control population to directly compare the pharmacokinetics in CF patients.'}}, 'adverseEventsModule': {'timeFrame': '10 days', 'eventGroups': [{'id': 'EG000', 'title': 'Tedizolid PO', 'description': 'Tedizolid phophate 200mg tablet\n\nTedizolid PO/IV: Participants will be randomized to receive tedizolid oral 200mg once daily for 3 days and crossed over to IV after a 1 week washout.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 1, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Tedizolid IV', 'description': 'Tedizolid phophate 200mg IV\n\nTedizolid IV/PO: Participants will be randomized to receive tedizolid IV 200mg once daily for 3 days and crossed over to PO after a 1 week washout.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 1, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Peak Plasma Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tedizolid PO', 'description': 'Tedizolid phophate 200mg tablet with crossover to IV\n\nTedizolid PO/IV: Participants will be randomized to receive tedizolid oral 200mg once daily for 3 days and crossed over to IV after a 1 week washout.'}, {'id': 'OG001', 'title': 'Tedizolid IV', 'description': 'Tedizolid phophate 200mg IV with crossover to PO\n\nTedizolid IV/PO: Participants will be randomized to receive tedizolid IV 200mg once daily for 3 days and crossed over to PO after a 1 week washout.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.22', 'spread': '0.745', 'groupId': 'OG000'}, {'value': '2.92', 'spread': '.624', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 days', 'description': 'Cmax was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose', 'unitOfMeasure': 'mg/liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Area Under the Plasma Concentration Versus Time Curve (AUC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tedizolid PO', 'description': 'Tedizolid phophate 200mg tablet with crossover to IV\n\nTedizolid PO/IV: Participants will be randomized to receive tedizolid oral 200mg once daily for 3 days and crossed over to IV after a 1 week washout.'}, {'id': 'OG001', 'title': 'Tedizolid IV', 'description': 'Tedizolid phophate 200mg IV with crossover to PO\n\nTedizolid IV/PO: Participants will be randomized to receive tedizolid IV 200mg once daily for 3 days and crossed over to PO after a 1 week washout.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.1', 'spread': '5.72', 'groupId': 'OG000'}, {'value': '20.7', 'spread': '3.92', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 days', 'description': 'Area under the curve was calculated using samples collected at baseline (0 h) , 0.5, 1, 2, 3, 4, 8, 24, and 48 hours post-dose and using the equation AUC=Dose\\*F/CL', 'unitOfMeasure': 'mg*h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Time to Peak Plasma Concentration (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tedizolid PO', 'description': 'Tedizolid phophate 200mg tablet with crossover to IV\n\nTedizolid PO/IV: Participants will be randomized to receive tedizolid oral 200mg once daily for 3 days and crossed over to IV after a 1 week washout.'}, {'id': 'OG001', 'title': 'Tedizolid IV', 'description': 'Tedizolid phophate 200mg IV with crossover to PO\n\nTedizolid IV/PO: Participants will be randomized to receive tedizolid IV 200mg once daily for 3 days and crossed over to PO after a 1 week washout.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'spread': '1.33', 'groupId': 'OG000'}, {'value': '1.36', 'spread': '0.369', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 days', 'description': 'Tmax was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Peak Sputum Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tedizolid PO', 'description': 'Tedizolid phophate 200mg tablet with crossover to IV\n\nTedizolid PO/IV: Participants will be randomized to receive tedizolid oral 200mg once daily for 3 days and crossed over to IV after a 1 week washout.'}, {'id': 'OG001', 'title': 'Tedizolid IV', 'description': 'Tedizolid phophate 200mg IV with crossover to PO\n\nTedizolid IV/PO: Participants will be randomized to receive tedizolid IV 200mg once daily for 3 days and crossed over to PO after a 1 week washout.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.08', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '1.196', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 days', 'description': 'Peak sputum concentration was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose.', 'unitOfMeasure': 'mg/liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One patient could not produce sputum'}, {'type': 'PRIMARY', 'title': 'Area Under the Sputum Concentration Versus Time Curve (AUC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tedizolid PO', 'description': 'Tedizolid phophate 200mg tablet with crossover to IV\n\nTedizolid PO/IV: Participants will be randomized to receive tedizolid oral 200mg once daily for 3 days and crossed over to IV after a 1 week washout.'}, {'id': 'OG001', 'title': 'Tedizolid IV', 'description': 'Tedizolid phophate 200mg IV with crossover to PO\n\nTedizolid IV/PO: Participants will be randomized to receive tedizolid IV 200mg once daily for 3 days and crossed over to PO after a 1 week washout.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.04', 'spread': '8.92', 'groupId': 'OG000'}, {'value': '13.53', 'spread': '7.203', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 days', 'description': 'AUC was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose', 'unitOfMeasure': 'mg*h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One patient could not produce sputum'}, {'type': 'PRIMARY', 'title': 'Time to Peak Sputum Concentration (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tedizolid PO', 'description': 'Tedizolid phophate 200mg tablet\n\nTedizolid PO/IV: Participants will be randomized to receive tedizolid oral 200mg once daily for 3 days and crossed over to IV after a 1 week washout.'}, {'id': 'OG001', 'title': 'Tedizolid IV', 'description': 'Tedizolid phophate 200mg IV\n\nTedizolid IV/PO: Participants will be randomized to receive tedizolid IV 200mg once daily for 3 days and crossed over to PO after a 1 week washout.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'spread': '0', 'groupId': 'OG000'}, {'value': '3', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 days', 'description': 'Tmax was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose. Tmax was derived from pooled sputum data due to sparse samples and therefore do not have standard deviations.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One patient could not produce sputum'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tedizolid PO/IV', 'description': 'Tedizolid phophate 200mg tablet with crossover to IV\n\nTedizolid PO/IV: Participants will be randomized to receive tedizolid oral 200mg once daily for 3 days and crossed over to IV after a minimum 2-day washout.'}, {'id': 'FG001', 'title': 'Tedizolid IV/PO', 'description': 'Tedizolid phophate 200mg IV with crossover to PO\n\nTedizolid IV/PO: Participants will be randomized to receive tedizolid IV 200mg once daily for 3 days and crossed over to PO after a minimum 2-day washout.'}], 'periods': [{'title': 'First Intervention (3 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout (2 Day Minimum)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention (3 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'This was a cross-over study where patients with CF received tedizolid 200mg IV or PO once daily for 3 doses followed by a minimum 2 day washout and receipt of the remaining dosage form.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'Participants were randomized to receive either tedizolid oral 200 mg tablet or IV 200 mg once daily for 3 days and crossed over to either IV or PO after a minimum of 2 day washout period'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '27.27', 'spread': '4.78', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Creatinine Clearance', 'classes': [{'categories': [{'measurements': [{'value': '147.6', 'spread': '32.43', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mL/min', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '21.72', 'spread': '3.60', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-07-26', 'size': 232696, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-04-09T16:04', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-21', 'studyFirstSubmitDate': '2015-05-06', 'resultsFirstSubmitDate': '2019-04-25', 'studyFirstSubmitQcDate': '2015-05-11', 'lastUpdatePostDateStruct': {'date': '2020-06-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-05-15', 'studyFirstPostDateStruct': {'date': '2015-05-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak Plasma Concentration (Cmax)', 'timeFrame': '2 days', 'description': 'Cmax was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose'}, {'measure': 'Area Under the Plasma Concentration Versus Time Curve (AUC)', 'timeFrame': '2 days', 'description': 'Area under the curve was calculated using samples collected at baseline (0 h) , 0.5, 1, 2, 3, 4, 8, 24, and 48 hours post-dose and using the equation AUC=Dose\\*F/CL'}, {'measure': 'Time to Peak Plasma Concentration (Tmax)', 'timeFrame': '2 days', 'description': 'Tmax was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose'}, {'measure': 'Peak Sputum Concentration', 'timeFrame': '2 days', 'description': 'Peak sputum concentration was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose.'}, {'measure': 'Area Under the Sputum Concentration Versus Time Curve (AUC)', 'timeFrame': '2 days', 'description': 'AUC was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose'}, {'measure': 'Time to Peak Sputum Concentration (Tmax)', 'timeFrame': '2 days', 'description': 'Tmax was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose. Tmax was derived from pooled sputum data due to sparse samples and therefore do not have standard deviations.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': 'The proposed study is designed to characterize the pharmacokinetics of intravenous and oral tedizolid in patients with Cystic Fibrosis.', 'detailedDescription': 'Recent epidemiological studies have demonstrated that the presence of methicillin-resistant Staphylococcus aureus (MRSA) in the airways of patients with CF is associated with more rapid lung function decline and a higher mortality. Tedizolid is a new antibiotic with potent activity against MRSA. Tedizolid is currently FDA approved for treatment of skin soft tissue infections with MRSA. The proposed study is designed to characterize the pharmacokinetics of intravenous and oral tedizolid in patients with CF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of CF based on positive sweat chloride or known CF mutation\n* Age \\> 17 years\n* Able to spontaneously expectorate sputum\n\nExclusion Criteria:\n\n* Any clinically significant laboratory abnormalities\n* Presence of an ongoing acute pulmonary exacerbation\n* Pregnancy\n* Serious past allergy to linezolid or tedizolid\n* No alcohol, nicotine, or caffeine-containing products during the study period'}, 'identificationModule': {'nctId': 'NCT02444234', 'briefTitle': 'Pharmacokinetics of Tedizolid Phosphate in Cystic Fibrosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern California'}, 'officialTitle': 'Steady-State Pharmacokinetics of Tedizolid in Plasma and Sputum of Patients With Cystic Fibrosis', 'orgStudyIdInfo': {'id': 'HS-15-00182'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tedizolid PO', 'description': 'Tedizolid phophate 200mg tablet', 'interventionNames': ['Drug: Tedizolid PO']}, {'type': 'EXPERIMENTAL', 'label': 'Tedizolid IV', 'description': 'Tedizolid phophate 200mg IV', 'interventionNames': ['Drug: Tedizolid IV']}], 'interventions': [{'name': 'Tedizolid PO', 'type': 'DRUG', 'description': 'Participants will be randomized to receive tedizolid oral 200mg once daily for 3 days and crossed over to IV after a 1 week washout.', 'armGroupLabels': ['Tedizolid PO']}, {'name': 'Tedizolid IV', 'type': 'DRUG', 'description': 'Participants will be randomized to receive tedizolid IV 200mg once daily for 3 days and crossed over to PO after a 1 week washout.', 'armGroupLabels': ['Tedizolid IV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90089', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern California', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Paul Beringer', 'investigatorAffiliation': 'University of Southern California'}}}}