Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-25 @ 7:06 PM
Study NCT ID:
NCT01210404
Status:
COMPLETED
Last Update Posted:
2011-06-07
First Post:
2010-09-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Drug Interaction Study Of Filibuvir With Methadone Among Subjects On Chronic Methadone Maintenance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'C550357', 'term': 'filibuvir'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-06', 'studyFirstSubmitDate': '2010-09-27', 'studyFirstSubmitQcDate': '2010-09-27', 'lastUpdatePostDateStruct': {'date': '2011-06-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Methadone plasma pharmacokinetic parameters, AUC24, Cmax', 'timeFrame': 'day 1'}, {'measure': 'Methadone plasma pharmacokinetic parameters, AUC24, Cmax', 'timeFrame': 'day 11'}], 'secondaryOutcomes': [{'measure': 'Methadone plasma pharmacokinetic parameters Tmax and C24h', 'timeFrame': 'day 1'}, {'measure': 'Methadone plasma pharmacokinetic parameters Tmax and C24h', 'timeFrame': 'day 11'}, {'measure': 'Filibuvir plasma pharmacokinetic parameters: Auc 12, Cmax, and Tmax.', 'timeFrame': 'day 2'}, {'measure': 'Filibuvir plasma pharmacokinetic parameters: Auc 12, Cmax, and Tmax.', 'timeFrame': 'day 11'}, {'measure': 'Safety and tolerability, including adverse events, vital signs, 12 lead ECG and lab safety assessments.', 'timeFrame': 'days 0-12'}, {'measure': 'Symptoms of methadone withdrawal as assessed by short Opiate Withdrawal Scale, Desires for Drug questionnaire and pupillary diameter measurement .', 'timeFrame': 'days 0-12'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Drug interaction with methadone.'], 'conditions': ['Chronic Hepatitis C']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A8121023&StudyName=Drug%20Interaction%20Study%20Of%20Filibuvir%20With%20Methadone%20Among%20Subjects%20On%20Chronic%20Methadone%20Maintenance', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'Filibuvir, a CYP3A4 inhibitor is being developed for the treatment of chronic Hepatitis C infection. Given the likelihood of co administration of filibuvir and methadone, this study will evaluate the effect of filibuvir on the pharmacokinetics of R/S Methadone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females, without evidence of infection with HIV,HBV or HCV, who are on chronic methadone maintenance for at least three months and at a stable dose for at least 1 week prior to study start.\n\nExclusion Criteria:\n\n* Evidence of chronic diseases including HIV, HBV or HCV.\n* Evidence of acute or chronic liver disease.\n* Treatment with prescription or nonprescription drugs other than methadone within 7 days.'}, 'identificationModule': {'nctId': 'NCT01210404', 'briefTitle': 'Drug Interaction Study Of Filibuvir With Methadone Among Subjects On Chronic Methadone Maintenance', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Open Label Single Sequence Study To Estimate The Effect Of Filibuvir (PF-00868554) On S-And R-Methadone In Subjects Receiving Chronic Methadone Treatment And To Evaluate The Pharmacokinetics Of Filibuvir', 'orgStudyIdInfo': {'id': 'A8121023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1.0', 'interventionNames': ['Drug: filibuvir']}], 'interventions': [{'name': 'filibuvir', 'type': 'DRUG', 'description': 'Filibuvir, 600mg bid administered along with methadone on days 2-11', 'armGroupLabels': ['1.0']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66211', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '66212', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Director, Clinical Trial Disclosure Group', 'oldOrganization': 'Pfizer, Inc.'}}}}