Ignite Creation Date:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT00671359
Status:
COMPLETED
Last Update Posted:
2018-04-04
First Post:
2008-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Food Effects of Single Oral Dose of 600mg TR-701
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C515040', 'term': 'tedizolid phosphate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2008-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-03', 'studyFirstSubmitDate': '2008-05-01', 'studyFirstSubmitQcDate': '2008-05-02', 'lastUpdatePostDateStruct': {'date': '2018-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-05-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the safety and tolerability of TR-701 600mg given as a single oral dose.', 'timeFrame': '4 days'}], 'secondaryOutcomes': [{'measure': 'To evaluate the pharmacokinetics of single doses of TR-701 and its microbiologically active moiety, TR-700, in healthy adult volunteers in the fed and fasted state', 'timeFrame': '4 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Food effects'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '23926058', 'type': 'DERIVED', 'citation': 'Flanagan SD, Bien PA, Munoz KA, Minassian SL, Prokocimer PG. Pharmacokinetics of tedizolid following oral administration: single and multiple dose, effect of food, and comparison of two solid forms of the prodrug. Pharmacotherapy. 2014 Mar;34(3):240-50. doi: 10.1002/phar.1337. Epub 2013 Aug 7.'}]}, 'descriptionModule': {'briefSummary': 'This is an evaluation of the safety, tolerance, and pharmacokinetics of single oral doses of TR-701 given to normal, healthy, adult volunteers in the fed and fasted state.', 'detailedDescription': 'Subjects will receive the following treatments in a crossover design:\n\nTreatment A: Three 200-mg capsules (600-mg dose) of TR-701 administered orally with 240 mL room temperature tap water after at least a 10-hour fast.\n\nTreatment B: Three 200-mg capsules (600-mg dose) of TR-701 administered orally with 240 mL room temperature tap water following a high-fat meal preceded by at least a 10-hour fast.\n\nDescriptive statistics will be calculated for PK parameters where available, including Cmax, Tmax, AUC0-t, and AUC0-inf. Minimum, maximum, mean, and median values will be determined and standard deviations will be calculated. Where data are available, food effect will be examined between test (fed state) and reference (fasted state) groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI of 20 to 29.9 kg/m2\n* Females must be either postmenopausal for at least 1 year, surgically sterile for at least 90 days, or agree to use an acceptable method of birth control\n\nExclusion Criteria:\n\n* history or clinical manifestations of any clinically significant medical disorder\n* history of hypersensitivity or allergies to any drug compound\n* history of stomach or intestinal surgery or resection\n* history of alcoholism or drug addiction within 1 year\n* pregnancy, lactation, or breastfeeding\n* use of any tobacco-containing or nicotine-containing products within 6 months\n* use of any other medications\n* use of alcohol-containing, grapefruit-containing, or caffeine-containing foods or beverages; or foods or beverages with high levels of tyramine'}, 'identificationModule': {'nctId': 'NCT00671359', 'briefTitle': 'Food Effects of Single Oral Dose of 600mg TR-701', 'organization': {'class': 'INDUSTRY', 'fullName': 'Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)'}, 'officialTitle': 'An Open-Label, Single-Dose, Two-Treatment, Randomized, Two-Way Crossover, Safety, Tolerance, and Pharmacokinetic Study of TR-701 in Normal Healthy Adults in the Fed and Fasted State', 'orgStudyIdInfo': {'id': '1986-023'}, 'secondaryIdInfos': [{'id': 'TR701-103', 'type': 'OTHER', 'domain': 'TriusRX Unique ID'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'after fast', 'description': 'Administration of a single oral dose of 600mg TR-701 to subjects in the fasted state.', 'interventionNames': ['Drug: TR-701 600mg']}, {'type': 'EXPERIMENTAL', 'label': 'After high fat food', 'description': 'Administration of a single oral dose of 600mg TR-701 to subjects in the fed state.', 'interventionNames': ['Drug: TR-701 600mg']}], 'interventions': [{'name': 'TR-701 600mg', 'type': 'DRUG', 'description': 'TR-701 600mg', 'armGroupLabels': ['After high fat food', 'after fast']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Covance CRU', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Michael Berry, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Covance CRU'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}