Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2026-02-02 @ 5:35 PM
Study NCT ID:
NCT01060566
Status:
COMPLETED
Last Update Posted:
2010-04-16
First Post:
2010-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of VX-770 on Midazolam and Rosiglitazone and the Effect of Fluconazole on VX-770
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C545203', 'term': 'ivacaftor'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-04-15', 'studyFirstSubmitDate': '2010-01-29', 'studyFirstSubmitQcDate': '2010-02-01', 'lastUpdatePostDateStruct': {'date': '2010-04-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Midazolam, Rosiglitazone and VX 770 pharmacokinetic (PK) parameter', 'timeFrame': '11 days'}, {'measure': 'Fluconazole and VX 770 PK parameters', 'timeFrame': '10 days'}], 'secondaryOutcomes': [{'measure': '1ยด hydroxy midazolam PK parameters in plasma', 'timeFrame': '11 days'}, {'measure': 'Safety as measured by adverse events, physical examinations, vital signs, ECGs, and clinically significant laboratory assessments', 'timeFrame': '21 days'}, {'measure': 'Metabolites PK parameters in plasma', 'timeFrame': '21 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': 'The objectives of this study are to evaluate the effects of VX-770 on Midazolam and Rosiglitazone, and the effect of Fluconazole on VX-770.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects must be male or female and between 18 and 55 years of age.\n* Subjects must be judged to be in good health.\n* Subjects must have a body mass index (BMI) from 18 to 30 kg/m2.\n\nExclusion Criteria:\n\n* History of any illness that, in the opinion of the investigator or the subject's general practitioner, might confound the results of the study or pose an additional risk in administering study drug(s) to the subject.\n* Subjects who have human immunodeficiency virus (HIV), hepatitis C, or active hepatitis B.\n* Female subjects and female partner(s) of male subjects who are pregnant, nursing, or planning to become pregnant during the study or within 90 days of the last dose of study drug.\n* History of cardiovascular disease, hypoglycemia, or edema."}, 'identificationModule': {'nctId': 'NCT01060566', 'briefTitle': 'Study of VX-770 on Midazolam and Rosiglitazone and the Effect of Fluconazole on VX-770', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vertex Pharmaceuticals Incorporated'}, 'officialTitle': 'An Open-Label Phase 1 Study to Examine the Effect of VX-770 on Midazolam and Rosiglitazone and the Effect of Fluconazole on VX-770 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'VX09-770-010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VX-770', 'interventionNames': ['Drug: VX-770']}, {'type': 'EXPERIMENTAL', 'label': 'Midazolam', 'interventionNames': ['Drug: VX-770']}, {'type': 'EXPERIMENTAL', 'label': 'Rosiglitazone', 'interventionNames': ['Drug: VX-770']}, {'type': 'EXPERIMENTAL', 'label': 'Fluconazole', 'interventionNames': ['Drug: VX-770']}], 'interventions': [{'name': 'VX-770', 'type': 'DRUG', 'description': 'In period 1, subjects will receive a single oral dose of midazolam (2 mg) and on Day 1 and Day 8. Subjects will receive single oral dose of rosiglitazone 4 mg and on Day2 and Day 9. Subjects will receive multiple doses of VX-770 150 mg q12h Day 3-10.', 'armGroupLabels': ['Midazolam', 'Rosiglitazone', 'VX-770']}, {'name': 'VX-770', 'type': 'DRUG', 'description': 'In period 2, subjects will receive 150 mg VX-770 q12h orally from Day 1 through the morning of Day 8. On the morning of Period 2 Day 1, subjects will receive a 400 mg loading dose of fluconazole. Thereafter, subjects will receive 200 mg fluconazole qd orally from Day 2 through Day 9.', 'armGroupLabels': ['Fluconazole', 'VX-770']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32117', 'city': 'Daytona Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Covan CRU, Inc.', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}], 'overallOfficials': [{'name': 'H. Frank Farmer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Covance CRU, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vertex Pharmaceuticals Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Medical Monitor', 'oldOrganization': 'Vertex Pharmaceuticals Incorporated'}}}}