Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2025-12-25 @ 10:22 PM
Study NCT ID:
NCT00722358
Status:
COMPLETED
Last Update Posted:
2011-06-27
First Post:
2008-07-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Multiple Ascending Dose Study of BMS-650032 in HCV Infected Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Argentina']}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}], 'ancestors': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C571889', 'term': 'asunaprevir'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'dispFirstSubmitDate': '2011-06-15', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-15', 'studyFirstSubmitDate': '2008-07-23', 'dispFirstSubmitQcDate': '2011-06-15', 'studyFirstSubmitQcDate': '2008-07-23', 'dispFirstPostDateStruct': {'date': '2011-06-27', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2011-06-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antiviral activity will be assessed by the magnitude and rate of change in plasma HCV RNA levels from baseline. The primary endpoint for antiviral activity is decrease from baseline in plasma HCV RNA levels to Day 3/ or 5', 'timeFrame': 'To assess the change in HCV RNA during dosing with BMS-650032 from baseline to Day 3 and during follow-up period'}], 'secondaryOutcomes': [{'measure': 'PD-PK Relationship Measures: Asses relationship between antiviral activity and measures of exposure to BMS-650032', 'timeFrame': '28 days after drug'}, {'measure': 'Safety Outcome Measures: Safety and tolerability assessments', 'timeFrame': 'will be performed for a period of 28 days after administration of multiple doses of BMS-650032 for 3/ or 5 days'}, {'measure': 'Pharmacokinetic Measures: Pharmacokinetic assessments', 'timeFrame': 'will be done on Day 1 for one dosing interval after the AM dose and on Day 3/ or 5 for 72 hours after the last AM dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Hepatitis C']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to assess the change in HCV RNA during dosing with BMS-650032 and during the follow-up period in subjects with chronic hepatitis C infection'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronically infected with HCV genotype 1\n* Treatment naive\n* HCV RNA viral load of ≥10\\*5 IU/mL\n* BMI 18 to 35kg/m²\n\nExclusion Criteria:\n\n* Women of childbearing potential (WOCBP)\n* Any significant acute or chronic medical illness which is not stable or is not controlled with medication and not consistent with HCV infection\n* HCV infected subjects who are treatment non-responder (defined as subject who received at least 12 weeks of SOC and continue to have a detectable HCV RNA level or subjects who did not attain a 2-log decline in HCV RNA levels at 12 weeks and stopped treatment\n* HCV infected subjects who are treatment intolerant (defined as subject who are unable to receive at least 12 weeks of SOC due to toxicities associated with interferon and/or ribavirin\n* HIV and/or HBV positive\n* Major surgery within 4 weeks of study drug administration and any gastrointestinal surgery that could impact the absorption of study drug'}, 'identificationModule': {'nctId': 'NCT00722358', 'briefTitle': 'A Multiple Ascending Dose Study of BMS-650032 in HCV Infected Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Antiviral Activity and Safety, Tolerability, and Pharmacokinetics of BMS-650032 in Subjects Infected With Hepatitis C Virus Genotype 1', 'orgStudyIdInfo': {'id': 'AI447-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'BMS-650032', 'interventionNames': ['Drug: BMS-650032']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'BMS-650032', 'type': 'DRUG', 'description': 'Capsule, Oral, Q12h, 3/5 days\n\nPanel 1: 200 mg\n\nPanel 2: 400 mg\n\nPanel 3: 600 mg', 'armGroupLabels': ['BMS-650032']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Capsule, Oral, Q 12h, 3/5 days\n\nPanel 1: matching placebo\n\nPanel 2: matching placebo\n\nPanel 3: matching placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Advanced Clinical Res Inst', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '32809', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Orlando Clinical Research Center', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '21225', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Parexel International Corporation', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Central Texas Clinical Research', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '00909', 'city': 'Santurce', 'country': 'Puerto Rico', 'facility': 'Local Institution', 'geoPoint': {'lat': 18.19523, 'lon': -67.14018}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Study Director', 'oldOrganization': 'Bristol-Myers Squibb'}}}}