Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-26 @ 12:27 AM
Study NCT ID:
NCT01461460
Status:
COMPLETED
Last Update Posted:
2018-12-05
First Post:
2011-10-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Thorough QT Study of TR-701free Acid (FA) in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C546016', 'term': 'tedizolid'}, {'id': 'D000077266', 'term': 'Moxifloxacin'}], 'ancestors': [{'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2011-12-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-03', 'studyFirstSubmitDate': '2011-10-26', 'studyFirstSubmitQcDate': '2011-10-27', 'lastUpdatePostDateStruct': {'date': '2018-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'QTcF Change from Baseline', 'timeFrame': '24 Hours', 'description': 'Time-matched, placebo adjusted change from the baseline QTcF (ΔΔQTcF).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['volunteer'], 'conditions': ['Healthy Volunteer']}, 'referencesModule': {'references': [{'pmid': '27342387', 'type': 'BACKGROUND', 'citation': 'Flanagan S, Litwin J, Fang E, Prokocimer P. Effects of therapeutic and supratherapeutic doses of oral tedizolid phosphate on cardiac repolarisation in healthy volunteers: a randomised controlled study. Int J Antimicrob Agents. 2016 Jul;48(1):33-40. doi: 10.1016/j.ijantimicag.2015.12.015. Epub 2016 Jun 2.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effects of oral TR-701 free acid (FA) versus placebo on QTcF.', 'detailedDescription': "To assess the effects of a single therapeutic (200 mg) and supratherapeutic of oral TR-701 free acid (FA) versus placebo on QT interval corrected for heart rate using Fridericia's formula (QTcF) in healthy subjects."}, '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.\n* Body mass index ≥18.0 kg/m2 and ≤30.0 kg/m2\n\nExclusion Criteria:\n\n* Sustained supine systolic blood pressure \\>140 or \\<100 mmHg or a diastolic blood pressure \\>90 or \\<60 mmHg at the Screening and Day 1 Visit.\n* Abnormal ECG at Screening or Day -1 Visits indicating a second or third-degree atrioventricular block, or QRS \\>110 msec, QTcF \\>450 msec for males and \\>470 msec for females, PR interval \\>200 msec, or any rhythm other than sinus rhythm which is interpreted by the Investigator as clinically significant - History of unexplained infections or current signs of infection\n* History of risk factors for Torsades de Pointes, including unexplained syncope, known Long QT Syndrome, heart failure, myocardial infarction, angina, or clinically significant abnormal laboratory assessments including hypokalemia, hypercalcemia, hypomagnesemia, or family history of Long QT Syndrome or Brugada Syndrome'}, 'identificationModule': {'nctId': 'NCT01461460', 'briefTitle': 'A Thorough QT Study of TR-701free Acid (FA) in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)'}, 'officialTitle': 'A Phase 1 Blinded, Placebo-controlled Crossover Study to Evaluate the Effects of Oral TR 701 Free Acid on the Electrocardiogram', 'orgStudyIdInfo': {'id': '1986-029'}, 'secondaryIdInfos': [{'id': 'TR701-115', 'type': 'OTHER', 'domain': 'TriusRX unique ID'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Moxifloxacin 400 mg', 'interventionNames': ['Drug: Moxifloxacin 400 mg']}, {'type': 'EXPERIMENTAL', 'label': 'TR-701 FA 1200 mg', 'interventionNames': ['Drug: TR-701 FA 1200 mg']}, {'type': 'EXPERIMENTAL', 'label': 'TR-701 FA 200 mg plus Placebo', 'interventionNames': ['Drug: TR-701 FA 200 mg plus Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'TR-701 FA 1200 mg', 'type': 'DRUG', 'otherNames': ['Tedizolid'], 'description': '6 tablet of T-701 FA', 'armGroupLabels': ['TR-701 FA 1200 mg']}, {'name': 'Moxifloxacin 400 mg', 'type': 'DRUG', 'description': '1 tablet 400 mg Moxifloxacin', 'armGroupLabels': ['Moxifloxacin 400 mg']}, {'name': 'TR-701 FA 200 mg plus Placebo', 'type': 'DRUG', 'otherNames': ['Tedizolid'], 'description': '1 tablet of TR-701 FA with 5 tablet placebo', 'armGroupLabels': ['TR-701 FA 200 mg plus Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '6 placebo tablets', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75247', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Trius Investigator', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], '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'}}}}