Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2025-12-25 @ 10:13 PM
Study NCT ID:
NCT01577459
Status:
COMPLETED
Last Update Posted:
2018-08-21
First Post:
2012-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1 Crossover Study of Blood Pressure and Heart Rate Response
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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2012-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-19', 'studyFirstSubmitDate': '2012-04-11', 'studyFirstSubmitQcDate': '2012-04-12', 'lastUpdatePostDateStruct': {'date': '2018-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-04-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systolic Blood Pressure', 'timeFrame': '13 days', 'description': 'To compare systolic blood pressure post administration of pseudoepherine concurrent with TR-701 FA and Placebo'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Subjects']}, 'referencesModule': {'references': [{'pmid': '29899212', 'type': 'RESULT', 'citation': 'Flanagan S, Minassian SL, Prokocimer P. Pharmacokinetics of Tedizolid and Pseudoephedrine Administered Alone or in Combination in Healthy Volunteers. J Clin Med. 2018 Jun 14;7(6):150. doi: 10.3390/jcm7060150.'}, {'pmid': '23612197', 'type': 'DERIVED', 'citation': 'Flanagan S, Bartizal K, Minassian SL, Fang E, Prokocimer P. In vitro, in vivo, and clinical studies of tedizolid to assess the potential for peripheral or central monoamine oxidase interactions. Antimicrob Agents Chemother. 2013 Jul;57(7):3060-6. doi: 10.1128/AAC.00431-13. Epub 2013 Apr 22.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-blinded, placebo-controlled, crossover study to evaluate the pressor effects of pseudoephedrine when administered with TR-701 FA in healthy adult volunteers.', 'detailedDescription': 'Eligible subjects will be randomized to 1 of 2 possible treatment sequences (N=9 per sequence) on Study Day 1. Subjects will receive oral 200 mg TR 701 FA or Placebo for TR 701 FA once daily for 5 days during each treatment period, with a 2 day washout between periods (72 hours between doses). On Study Day 5 of each treatment period, subjects will also receive oral 60 mg PSE.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female subjects between 18 and 45 years of age, inclusive\n* Healthy males and females with no clinically significant abnormalities identified by a detailed medical history\n* Body mass index ≥ 19.0 kg/m2 and ≤ 31.0 kg/m2\n\nExclusion Criteria:\n\n* Systolic blood pressure \\> 130 mmHg or \\< 90 mmHg measured after 10 minutes supine at the Screening Visit and Study Day 1\n* Diastolic blood pressure \\> 90 mmHg or \\< 60 mmHg measured after 10 minutes supine at the Screening Visit and Study Day 1\n* Heart rate \\> 90 bpm or \\< 50 bpm measured after 10 minutes supine at the Screening Visit and Study Day\n* Known allergy or hypersensitivity to PSE'}, 'identificationModule': {'nctId': 'NCT01577459', 'briefTitle': 'A Phase 1 Crossover Study of Blood Pressure and Heart Rate Response', 'organization': {'class': 'INDUSTRY', 'fullName': 'Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)'}, 'officialTitle': 'A Phase 1 Crossover Study of Blood Pressure and Heart Rate Response to Pseudoephedrine Concurrent With Placebo or TR 701 FA', 'orgStudyIdInfo': {'id': '1986-033'}, 'secondaryIdInfos': [{'id': 'TR701-114', 'type': 'OTHER', 'domain': 'TriusRX Unique ID'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TR-701 FA with PSE', 'description': 'TR-701 FA 200 mg oral with PSE', 'interventionNames': ['Drug: TR-701 FA with PSE']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'TR-701 FA Placebo with PSE', 'description': 'TR-701 FA Placebo 200 mg oral with PSE', 'interventionNames': ['Other: TR-701 FA Placebo with PSE']}], 'interventions': [{'name': 'TR-701 FA with PSE', 'type': 'DRUG', 'otherNames': ['Tedizolid Phosphate'], 'description': 'TR-701 FA Oral 200 mg oral with PSE', 'armGroupLabels': ['TR-701 FA with PSE']}, {'name': 'TR-701 FA Placebo with PSE', 'type': 'OTHER', 'description': 'TR-701 FA Placebo Oral 200 mg with PSE', 'armGroupLabels': ['TR-701 FA Placebo with PSE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66212', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Trius Investigator Site 001', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}], 'overallOfficials': [{'name': 'Philippe G Prokocimer, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Trius Therapeutics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}