Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 10:58 PM
Study NCT ID:
NCT01038167
Status:
COMPLETED
Last Update Posted:
2010-04-08
First Post:
2009-12-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Examine the Effects of Telaprevir on the Pharmacokinetics of Cyclosporine and Tacrolimus in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'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': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C486464', 'term': 'telaprevir'}, {'id': 'D016572', 'term': 'Cyclosporine'}, {'id': 'D016559', 'term': 'Tacrolimus'}], 'ancestors': [{'id': 'D003524', 'term': 'Cyclosporins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-04-06', 'studyFirstSubmitDate': '2009-12-18', 'studyFirstSubmitQcDate': '2009-12-18', 'lastUpdatePostDateStruct': {'date': '2010-04-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part A only: Pharmacokinetic parameters of cyclosporine (Cmax, AUC0-tlast, AUC0-inf, tmax, t1/2)', 'timeFrame': '33 days'}, {'measure': 'Part A and Part B: Pharmacokinetic parameters of telaprevir (Cmax, AUC0-8h, Cmin, tmax)', 'timeFrame': '33 days for Part A; 44 days for Part B'}, {'measure': 'Part B only: Pharmacokinetic parameters of tacrolimus (Cmax, AUC0-tlast, AUC0-inf, tmax, t1/2)', 'timeFrame': '44 days'}], 'secondaryOutcomes': [{'measure': 'Part A and Part B: Safety and tolerability as measured by adverse events, clinical laboratory assessments, electrocardiograms, vital signs, physical examinations', 'timeFrame': '33 days for Part A; 44 days for Part B'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['VX-950'], 'conditions': ['Hepatitis C']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect that telaprevir has on the pharmacokinetics of cyclosporine and tacrolimus. Pharmacokinetics means how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy female (non-childbearing potential) or male subjects between 18 and 60 years of age (inclusive)\n* Body mass index (BMI) from 18 to 30 kg/m2 (inclusive) at the Screening Visit and Day 1, and weigh more than 50 kg at Screening.\n\nExclusion Criteria:\n\n* History of any illness or condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject.\n* Participated in a clinical study involving administration of either an investigational or a marketed drug within 2 months or 5 half-lives (whichever is longer) before the Screening Visit.\n* Positive result for any of the following infectious disease tests: hepatitis B antigen, hepatitis C virus antibody, human immunodeficiency virus 1 antibody, or human immunodeficiency virus 2 antibody.'}, 'identificationModule': {'nctId': 'NCT01038167', 'briefTitle': 'A Study to Examine the Effects of Telaprevir on the Pharmacokinetics of Cyclosporine and Tacrolimus in Healthy Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vertex Pharmaceuticals Incorporated'}, 'officialTitle': 'An Open-Label Phase 1 Study in Healthy Adult Subjects to Examine the Effects of Telaprevir on the Pharmacokinetics of Cyclosporine and Tacrolimus', 'orgStudyIdInfo': {'id': 'VX09-950-021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A', 'description': 'Part A will be administered in two periods, separated by a washout. In Period 1, subjects will receive cyclosporine alone. In Period 2, subjects will receive cyclosporine in combination with telaprevir.', 'interventionNames': ['Drug: telaprevir', 'Drug: cyclosporine']}, {'type': 'EXPERIMENTAL', 'label': 'Part B', 'description': 'Part B will be administered in two periods, separated by a washout. In Period 1, subjects will receive tacrolimus alone. In Period 2, subjects will receive tacrolimus in combination with telaprevir.', 'interventionNames': ['Drug: telaprevir', 'Drug: tacrolimus']}], 'interventions': [{'name': 'telaprevir', 'type': 'DRUG', 'description': 'Tablet, Oral, 750mg, every 8 hours, Day 1-11 of Period 2', 'armGroupLabels': ['Part A']}, {'name': 'telaprevir', 'type': 'DRUG', 'description': 'Tablet, Oral, 750mg, every 8 hours, Day 1-13 of Period 2', 'armGroupLabels': ['Part B']}, {'name': 'cyclosporine', 'type': 'DRUG', 'description': 'Solution, Oral, 100mg, Day 1 of Period 1', 'armGroupLabels': ['Part A']}, {'name': 'cyclosporine', 'type': 'DRUG', 'description': 'Solution, Oral, 10mg, Day 1 and Day 8 of Period 2', 'armGroupLabels': ['Part A']}, {'name': 'tacrolimus', 'type': 'DRUG', 'description': 'Capsule, Oral, 2mg, Day 1 of Period 1', 'armGroupLabels': ['Part B']}, {'name': 'tacrolimus', 'type': 'DRUG', 'description': 'Capsule, Oral, 0.5mg, Day 8 of Period 2', 'armGroupLabels': ['Part B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Vertex Pharmaceuticals Incorporated'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vertex Pharmaceuticals Incorporated', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Tibotec Pharmaceutical Limited', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Robert Kauffman, M.D., Ph.D.', 'oldOrganization': 'Vertex Pharmaceuticals Incorporated'}}}}