Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2025-12-25 @ 7:26 PM
Study NCT ID:
NCT01511432
Status:
COMPLETED
Last Update Posted:
2012-07-04
First Post:
2012-01-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Assess the Relative Bioavailability Three New Formulations of Telaprevir in Healthy Subjects
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-03', 'studyFirstSubmitDate': '2012-01-09', 'studyFirstSubmitQcDate': '2012-01-17', 'lastUpdatePostDateStruct': {'date': '2012-07-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PK parameters: Maximum plasma concentration (Cmax), area under the concentration versus time curve (AUC) from time 0 to infinity (AUC0-∞)', 'timeFrame': 'Up to 57 days'}, {'measure': '• PK parameters: Maximum plasma concentration (Cmax), area under the concentration versus time curve AUC from time 0 to last time point (AUC0-tlast)', 'timeFrame': 'Up to 57 Days'}], 'secondaryOutcomes': [{'measure': 'The safety and tolerability of 3 oral formulations of telaprevir as assessed by adverse events, serious adverse events and results of clinical laboratory tests (serum chemistry, hematology, and urinalysis), vital signs, and 12-lead electrocardiograms', 'timeFrame': 'Up to 57days'}, {'measure': 'Time to reach Cmax after dosing (tmax) and terminal half-life (t1/2) of telaprevir', 'timeFrame': 'Up to 57 Days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Relative bioavailability', 'telaprevir formulations'], 'conditions': ['Chronic Hepatitis C']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the relative bioavailability, safety, and tolerability of 3 new formulations of telaprevir relative to the Incivek 375-mg tablets.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects (male and female of non-childbearing potential) between the ages of 18 and 55 years\n* Non-childbearing potential female subjects\n* Male subjects and female partners must agree to use at least 2 methods of contraception\n* Subjects with a body mass index (BMI) of 18 to 30 kg/m2 and weigh \\>50 kg at the Screening Visit.\n\nExclusion Criteria:\n\n* Subjects with a positive test result for hepatitis B, hepatitis C, or HIV\n* Subjects with a significant history of any illness, as deemed important by the investigator or any condition possibly affecting drug absorption\n* Subjects with a positive urine screen for drugs of abuse\n* Subjects with a history of regular alcohol consumption\n* Subjects treated with an investigational drug within 30 days\n* For Part A only: Subjects with 12-lead ECG QTcF \\>450 msec (males) or QTcF \\>470 msec (females) at the Screening Visit\n* Subjects who use prescription and/or nonprescription medications or vitamins and/or dietary supplements\n* Subjects who have made a blood donation of approximately 1 pint (500 mL) within 56 days prior to the first dose of study drug\n* Subjects who have a female partner who is pregnant, nursing, or planning to become pregnant during the study or within 90 days of the last dose of study drug\n* Subjects on hormone replacement therapy (HRT) must discontinue such therapy 28 days prior to the first dose of study drug\n* Subjects who have a habit of using tobacco or nicotine containing products within 6 months before the Screening Visit'}, 'identificationModule': {'nctId': 'NCT01511432', 'briefTitle': 'A Study to Assess the Relative Bioavailability Three New Formulations of Telaprevir in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vertex Pharmaceuticals Incorporated'}, 'officialTitle': 'A Two-Part, Phase 1, Randomized, Open-Label, Crossover Study to Evaluate the Relative Bioavailability of 3 Novel Oral Formulations of Telaprevir Relative to Incivek 375-mg Tablets When Administered as a Single 1125-mg Dose to Healthy Subjects', 'orgStudyIdInfo': {'id': 'VX11-950-025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A', 'description': 'Part A will be a 4-formulation, 4-sequence, 4-period crossover relative bioavailability study of 3 novel oral telaprevir formulations relative to the 375-mg Incivek tablet in the fed state.', 'interventionNames': ['Drug: telaprevir formulation A', 'Drug: telaprevir Formulation B', 'Drug: telaprevir Formulation C', 'Drug: telaprevir Formulation D']}, {'type': 'EXPERIMENTAL', 'label': 'Part B', 'description': 'Part B will be a 2-formulation, 6-sequence, 3-period cross-over relative bioavailability study of the novel oral telaprevir formulation selected from Part A in the fasted relative to the fed state and relative to the 375-mg Incivek tablet in the fasted state', 'interventionNames': ['Drug: telaprevir formulation A', 'Drug: telaprevir Formulation B', 'Drug: telaprevir Formulation C', 'Drug: telaprevir Formulation D']}], 'interventions': [{'name': 'telaprevir formulation A', 'type': 'DRUG', 'description': 'A single 1125-mg dose administered orally', 'armGroupLabels': ['Part A', 'Part B']}, {'name': 'telaprevir Formulation B', 'type': 'DRUG', 'description': 'A single 1125-mg dose administered orally', 'armGroupLabels': ['Part A', 'Part B']}, {'name': 'telaprevir Formulation C', 'type': 'DRUG', 'description': 'A single 1125-mg dose administered orally', 'armGroupLabels': ['Part A', 'Part B']}, {'name': 'telaprevir Formulation D', 'type': 'DRUG', 'description': 'A single 1125-mg dose administered orally', 'armGroupLabels': ['Part A', 'Part B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75247', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '53704', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Wisconsin', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vertex Pharmaceuticals Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}