Ignite Creation Date:
2025-12-25 @ 2:48 AM
Ignite Modification Date:
2025-12-31 @ 12:22 PM
Study NCT ID:
NCT01431833
Status:
COMPLETED
Last Update Posted:
2016-05-20
First Post:
2011-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A PK and Safety Study in Subjects With Hepatic Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-19', 'studyFirstSubmitDate': '2011-08-05', 'studyFirstSubmitQcDate': '2011-09-09', 'lastUpdatePostDateStruct': {'date': '2016-05-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PK Assessment', 'timeFrame': '7 days', 'description': 'PK Assessment in moderate and severe hepatic impairment and matched controls.PK Assessments include plasma parameters maximum observed concentration (Cmax), time to occurrence of Cmax, area under the plasma concentration-time curve from Hour 0 to the last measurable concentration(AUC0-t), area under the plasma concentration-time curve from Hour 0 extrapolated to infinity (AUC0-∞)and systemic clearance.'}], 'secondaryOutcomes': [{'measure': 'Safety', 'timeFrame': '7 days', 'description': 'Safety Assessments evaluated through adverse events, laboratory evaluations (hematology and chemistry), vital signs, ECGs, and physical examinations, in moderate and severe hepatic impairment and matched controls.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hepatic Impairment', 'Matched control subjects'], 'conditions': ['Hepatic Impairment']}, 'referencesModule': {'references': [{'pmid': '25136024', 'type': 'DERIVED', 'citation': 'Flanagan S, Minassian SL, Morris D, Ponnuraj R, Marbury TC, Alcorn HW, Fang E, Prokocimer P. Pharmacokinetics of tedizolid in subjects with renal or hepatic impairment. Antimicrob Agents Chemother. 2014 Nov;58(11):6471-6. doi: 10.1128/AAC.03431-14. Epub 2014 Aug 18.'}]}, 'descriptionModule': {'briefSummary': 'Assess the single dose PK and safety of TR701 FA in subjects with Moderate or Severe hepatic impairment versus matched control subjects with normal hepatic function.', 'detailedDescription': 'This study will assess the single-dose pharmacokinetics (PK) and safety of TR-701 free acid (FA) in subjects with Moderate or Severe hepatic impairment compared with matched control subjects with normal hepatic function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Moderate or severe hepatic impairment or matched control\n* BMI between 18.0 and 40.0 kg/m2\n\nExclusion Criteria:\n\n* Evidence of acute deterioration of hepatic function within 8 weeks\n* ALT or AST ≥ 5 times upper limit of normal for moderates; ALT or AST ≥ 8 times upper limit of normal for severes\n* Total bilirubin \\> 5 mg/dl for moderates; no upper limit for severes\n* Hemoglobin \\< 10g/dl for moderates; Hemoglobin \\< 9g/dl for severes'}, 'identificationModule': {'nctId': 'NCT01431833', 'briefTitle': 'A PK and Safety Study in Subjects With Hepatic Impairment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)'}, 'officialTitle': 'A Phase 1 Open-Label Study With Oral TR-701 FA to Assess Pharmacokinetics and Safety in Subjects With Moderate or Severe Hepatic Impairment', 'orgStudyIdInfo': {'id': '1986-001'}, 'secondaryIdInfos': [{'id': 'TR701-124', 'type': 'OTHER', 'domain': 'TriusRX Unique ID'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Moderate hepatic', 'interventionNames': ['Drug: TR-701 FA']}, {'type': 'EXPERIMENTAL', 'label': 'Severe Hepatic', 'interventionNames': ['Drug: TR-701 FA']}, {'type': 'EXPERIMENTAL', 'label': 'Matched control', 'interventionNames': ['Drug: TR-701 FA']}], 'interventions': [{'name': 'TR-701 FA', 'type': 'DRUG', 'description': 'Oral single dose 200 mg', 'armGroupLabels': ['Matched control', 'Moderate hepatic', 'Severe Hepatic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32809', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Trius Investigator Site 001', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '55404', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Trius Investigator Site 002', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Phillippe 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'}}}}