Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2026-03-05 @ 8:52 AM
Study NCT ID:
NCT02342418
Status:
COMPLETED
Last Update Posted:
2017-03-15
First Post:
2015-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Single Dose PK of IV Tedizolid Phosphate in Morbidly Obese and Non-Obese Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C515040', 'term': 'tedizolid phosphate'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'amitpai@med.umich.edu', 'phone': '7346470006', 'title': 'Manjunath Pai, Associate Professor', 'organization': 'University of Michigan'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Most of the participants were below 130 kg and so these data should not be extrapolated to adults above 130 kg.'}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Morbidly Obese', 'description': 'The morbidly obese (BMI ≥ 40 kg/m2) arm will be recruited first. Each morbidly obese subject will be matched to a non-obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.\n\nTedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.', 'otherNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Non-obese', 'description': 'Each non-obese subject will be matched to a morbidly obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.\n\nTedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.', 'otherNumAtRisk': 10, 'otherNumAffected': 1, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Intravascular Infiltration', 'notes': 'During the infusion of the drug into a vein in the drug leaked out to the blood vessel. This is a common side effect that can occur when drugs are administered through a vein.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'This Outcome Measure is the Tedizolid Area Under the Concentration Time-curve From Time 0 to 72 Hours in Morbidly Obese Subjects and Matched Non-obese Subjects.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Morbidly Obese', 'description': 'The morbidly obese (BMI ≥ 40 kg/m2) arm will be recruited first. Each morbidly obese subject will be matched to a non-obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.\n\nTedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.'}, {'id': 'OG001', 'title': 'Non-obese', 'description': 'Each non-obese subject will be matched to a morbidly obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.\n\nTedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.0', 'groupId': 'OG000', 'lowerLimit': '18.0', 'upperLimit': '42.0'}, {'value': '27.2', 'groupId': 'OG001', 'lowerLimit': '22.4', 'upperLimit': '56.0'}]}]}], 'analyses': [{'pValue': '0.314', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': '12 months', 'description': 'The area under the concentration-time curve is measured in units of mg of tedizolid per liter of plasma multiplied by time in hours (hour\\*mg/L) from time 0 to 72 hours. This comparison was made between the two groups of subjects that included morbidly obese subjects to matched non-obese subjects.', 'unitOfMeasure': 'hour*milligram/Liter', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'This Outcome Measure is the Maximum Plasma Concentration of Tedizolid in Morbidly Obese Subjects Compared to Nonobese Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Morbidly Obese', 'description': 'The morbidly obese (BMI ≥ 40 kg/m2) arm will be recruited first. Each morbidly obese subject will be matched to a non-obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.\n\nTedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.'}, {'id': 'OG001', 'title': 'Non-obese', 'description': 'Each non-obese subject will be matched to a morbidly obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.\n\nTedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.38', 'groupId': 'OG000', 'lowerLimit': '1.28', 'upperLimit': '3.99'}, {'value': '2.96', 'groupId': 'OG001', 'lowerLimit': '2.16', 'upperLimit': '5.27'}]}]}], 'analyses': [{'pValue': '0.214', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Wilcoxon matched-pair signed-rank test', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'The maximum concentration or Cmax value is measured in units of milligrams of tedizolid per liter of plasma.This comparison was made between the two groups of subjects that included morbidly obese subjects to matched non-obese subjects.', 'unitOfMeasure': 'Milligram per Liter', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Morbidly Obese', 'description': 'The morbidly obese (BMI ≥ 40 kg/m2) arm will be recruited first. Each morbidly obese subject will be matched to a non-obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.\n\nTedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.'}, {'id': 'FG001', 'title': 'Non-obese', 'description': 'Each non-obese subject will be matched to a morbidly obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.\n\nTedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Morbidly Obese', 'description': 'The morbidly obese (BMI ≥ 40 kg/m2) arm will be recruited first. Each morbidly obese subject will be matched to a non-obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.\n\nTedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.'}, {'id': 'BG001', 'title': 'Non-obese', 'description': 'Each non-obese subject will be matched to a morbidly obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.\n\nTedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000', 'lowerLimit': '26', 'upperLimit': '50'}, {'value': '37', 'groupId': 'BG001', 'lowerLimit': '24', 'upperLimit': '46'}, {'value': '37', 'groupId': 'BG002', 'lowerLimit': '24', 'upperLimit': '50'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '43.5', 'groupId': 'BG000', 'lowerLimit': '40.4', 'upperLimit': '51.8'}, {'value': '27.4', 'groupId': 'BG001', 'lowerLimit': '25.4', 'upperLimit': '29.1'}, {'value': '36.1', 'groupId': 'BG002', 'lowerLimit': '25.4', 'upperLimit': '51.8'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kilogram per square meter', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-25', 'studyFirstSubmitDate': '2015-01-09', 'resultsFirstSubmitDate': '2016-10-17', 'studyFirstSubmitQcDate': '2015-01-14', 'lastUpdatePostDateStruct': {'date': '2017-03-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-01-25', 'studyFirstPostDateStruct': {'date': '2015-01-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'This Outcome Measure is the Tedizolid Area Under the Concentration Time-curve From Time 0 to 72 Hours in Morbidly Obese Subjects and Matched Non-obese Subjects.', 'timeFrame': '12 months', 'description': 'The area under the concentration-time curve is measured in units of mg of tedizolid per liter of plasma multiplied by time in hours (hour\\*mg/L) from time 0 to 72 hours. This comparison was made between the two groups of subjects that included morbidly obese subjects to matched non-obese subjects.'}], 'secondaryOutcomes': [{'measure': 'This Outcome Measure is the Maximum Plasma Concentration of Tedizolid in Morbidly Obese Subjects Compared to Nonobese Subjects', 'timeFrame': '12 months', 'description': 'The maximum concentration or Cmax value is measured in units of milligrams of tedizolid per liter of plasma.This comparison was made between the two groups of subjects that included morbidly obese subjects to matched non-obese subjects.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '27185808', 'type': 'RESULT', 'citation': 'Pai MP. Pharmacokinetics of Tedizolid in Morbidly Obese and Covariate-Matched Nonobese Adults. Antimicrob Agents Chemother. 2016 Jul 22;60(8):4585-9. doi: 10.1128/AAC.00682-16. Print 2016 Aug.'}]}, 'descriptionModule': {'briefSummary': 'This is an open label, single-dose, pharmacokinetic study in 9 obese and 9 age-, sex-, ideal body weight- matched non-obese subjects. Qualifying subjects who have completed an informed consent will receive a single intravenous dose of tedizolid with the collection of 11 blood samples over 72 hours post dose.', 'detailedDescription': 'Subjects will present to the clinical research unit in the morning (approximately 6:30 a.m.) of the dosing day. A urine pregnancy test will be performed to rule out pregnancy prior to administration of the tedizolid phosphate dose to female subjects. The subject\'s height, total body weight, and vital signs (heart rate, blood pressure, temperature, and respiratory rate) will be recorded. Subjects judged (by study physician) to be healthy enough to participate will proceed with the study procedures.\n\nAn 18-20 gauge intravenous peripheral catheter will be inserted into the antecubital vein or a vein in the fore-arm of the non-dominant arm for sequential blood sampling, and an initial predose blood sample (5 mL) will be collected. A minimum of 3-5 mL of blood is required per pharmacokinetic sampling time-point. Each blood collection tube will be pre-labeled with: 1.) study protocol number; 2.) subject study number; 3.) date of collection; 4.) time-point. A 0.9% Sodium Chloride infusion may be run through the peripheral line at 30 to 40 mL per hour to maintain catheter patency for the 12 hour sampling phase. Alternatively, a heparin lock technique will be utilized to maintain intravascular catheter patency.\n\nA single-dose of tedizolid phosphate will be administered as an intravenous infusion (250 mL normal saline) over 1 hour (\\~8:00 a.m.). The intravenous administration tubing will be flushed with 0.9% Sodium Chloride infusion at 250 mL per hour (to match the tedizolid phosphate rate of infusion) for 10 minutes to ensure complete dose delivery. Blood samples (5 mL) will be collected 0.5 (middle of infusion), 1 (end of infusion), 2, 4, 6, 8, 12, 24, 48, and 72 hours post dose in blood collection tubes. The plasma will be harvested (centrifugation at 4°C) within 60 minutes of collection and stored at -70°C as two aliquots until analysis. The intravascular catheter "dead-space" volume will be discarded prior to blood sample collection by withdrawing 1.5-2 mL from the catheter to ensure no unintentional sample dilution. The intravascular catheter will be removed after the 12 hour sample and the subject will be discharged from the research unit. The subject will return to the research unit for blood sample collection on a daily basis at the following points: 24 (Visit 3), 48 (Visit 4), and 72 hours (Visit 5) after the dose via a peripheral vein needle stick. The exact date and time of blood sample collection will be recorded on case report forms. Each blood sample tube will be inverted and made up-right 5 times to afford mixing of blood with the anticoagulant. Blood samples will be maintained on wet ice and centrifuged at 1200 g for 10 minutes at 4°C within 60 minutes of collection to yield approximately 2 mL of plasma per 5 mL blood collection. The plasma samples will be transferred from the -20°C freezer for storage at -70°C at the end of the sample collection period until analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-smoking or light-smoking (≤ 5 cigarettes per day) volunteers\n* Estimated CLcr (Cockcroft-Gault equation) ≥ 90 mL/min\n* Female subjects of childbearing potential (CBP) either surgically sterilized, using hormonal contraceptives or an effective barrier method of contraception (diaphragm, cervical cap, condom) or agree to abstain from sex from the time of pre-study screening, during the entire study period and 4 weeks following the study period\n* Platelets count ≥ 140,000/mL\n* Absolute neutrophil count (ANC) ≥ 1800/mL\n\nExclusion Criteria:\n\n* History of hypersensitivity reaction to any oxazolidinone\n* BMI \\< 18.5 kg/m2\n* Any chronic medical condition requiring pharmacologic therapy\n* Transaminases (AST or ALT) \\> 2.5 x upper limit of normal\n* Total bilirubin \\> 1.5 x upper limit of normal\n* Positive urine pregnancy test (if female)\n* Abnormal electrocardiogram (ECG) as judged by the study physician\n* Unable to tolerate venipuncture and multiple blood draws\n* Clinically significant abnormal physical examination defined as a physical finding requiring further clinical work-up\n* Unable to independently provide a written informed consent'}, 'identificationModule': {'nctId': 'NCT02342418', 'briefTitle': 'Single Dose PK of IV Tedizolid Phosphate in Morbidly Obese and Non-Obese Adults', 'organization': {'class': 'OTHER', 'fullName': 'Albany College of Pharmacy and Health Sciences'}, 'officialTitle': 'Single Dose Pharmacokinetics of Intravenous Tedizolid Phosphate in Morbidly Obese and Age-, Sex-, and Ideal Body Weight-Matched Non-Obese Adults', 'orgStudyIdInfo': {'id': '14-019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Morbidly obese', 'description': 'The morbidly obese (BMI ≥ 40 kg/m2) arm will be recruited first. Each morbidly obese subject will be matched to a non-obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.', 'interventionNames': ['Drug: Tedizolid phosphate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-obese', 'description': 'Each non-obese subject will be matched to a morbidly obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.', 'interventionNames': ['Drug: Tedizolid phosphate']}], 'interventions': [{'name': 'Tedizolid phosphate', 'type': 'DRUG', 'otherNames': ['Sivextro'], 'description': 'Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.', 'armGroupLabels': ['Morbidly obese', 'Non-obese']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Manjunath Pai, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Summative data have been published'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amit.Pai', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Amit.Pai', 'investigatorAffiliation': 'Albany College of Pharmacy and Health Sciences'}}}}