Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2026-02-21 @ 1:20 AM
Study NCT ID:
NCT01592318
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2012-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of The Relative Bioavailability of Ritonavir-Boosted Danoprevir Fixed Dose Combination Tablets in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C553752', 'term': 'danoprevir'}, {'id': 'D019438', 'term': 'Ritonavir'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2012-04-24', 'studyFirstSubmitQcDate': '2012-05-03', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relative bioavailability of danoprevir: Area under the concentration-time curve (AUC)', 'timeFrame': 'Pre-dose and up to 24 hours post-dose Days 1, 8 and 15'}, {'measure': 'Pharmacokinetics of ritonavir: Area under the concentration-time curve (AUC)', 'timeFrame': 'Pre-dose and up to 24 hours post-dose Days 1, 8 and 15'}], 'secondaryOutcomes': [{'measure': 'Safety: Incidence of adverse events', 'timeFrame': 'approximately 2 months'}]}, 'conditionsModule': {'conditions': ['Healthy Volunteer']}, 'descriptionModule': {'briefSummary': 'This randomized, open-label, crossover study will evaluate the relative bioavailability of ritonavir-boosted danoprevir fixed dose combination tablets (FDC) as compared to ad hoc combination of reference tablets of danoprevir and ritonavir in healthy volunteers. Subjects will be randomized to 1 of 6 treatment sequences to receive single oral doses of either an FDC of danoprevir and ritonavir or danoprevir and ritonavir as separate tablets. In a crossover design, subjects will participate in 3 study periods with at least a 7-day washout between periods. In Part 2, single dose administration of film-coated FDCs will be compared to reference tablets.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female volunteers, 18 to 55 years of age\n* Body weight \\>/= 50.0 kg\n* Body mass index (BMI) 18.0 - 32.0 kg/m2\n* Healthy non-smoking subjects. Healthy status will be defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history and a complete physical examination\n* Medical history without major, recent, or ongoing pathology\n* Females of childbearing potential and males and their female partners of childbearing potential must agree to use 2 forms of contraception, 1 of which must be a barrier method, during the study and for 90 days after the last drug administration\n\nExclusion Criteria:\n\n* Pregnant or lactating women or males with female partners who are pregnant or lactating\n* Any history of clinically significant cardiovascular or cerebrovascular disease, hypertension, and/or infections\n* Positive result for drugs of abuse at screening or prior to admission to the clinical site during any study period\n* Positive for hepatitis B, hepatitis C or HIV infection\n* Current smokers or subjects who have discontinued smoking less than 6 months prior to first dose of study medication\n* Use of hormonal contraceptives (e.g. birth control pills, patches, injectable, implantable devices) within 30 days before the first dose of study medication\n* Use of an investigational drug or device within 30 days of the first dose of study medication (6 months for biologic therapies) or 5 half-lives of the investigational drug, whichever is longer\n* History of drug-related allergic reactions or hepatotoxicity\n* History (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average'}, 'identificationModule': {'nctId': 'NCT01592318', 'briefTitle': 'A Study of The Relative Bioavailability of Ritonavir-Boosted Danoprevir Fixed Dose Combination Tablets in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'An Up to Two-Part Relative Bioavailability Study of Ritonavir-Boosted Danoprevir Fixed Dose Combination Tablets as Compared to the Reference Phase 2 Ad Hoc Combination Tablets in Healthy Adult Volunteers', 'orgStudyIdInfo': {'id': 'NP28136'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'DNV + r reference', 'interventionNames': ['Drug: danoprevir', 'Drug: ritonavir']}, {'type': 'EXPERIMENTAL', 'label': 'DNV/r fixed dose combination', 'interventionNames': ['Drug: danoprevir', 'Drug: ritonavir']}], 'interventions': [{'name': 'danoprevir', 'type': 'DRUG', 'description': 'Fixed dose combination tablet with ritonavir, single oral dose', 'armGroupLabels': ['DNV/r fixed dose combination']}, {'name': 'danoprevir', 'type': 'DRUG', 'description': 'Reference tablet, single oral dose', 'armGroupLabels': ['DNV + r reference']}, {'name': 'ritonavir', 'type': 'DRUG', 'description': 'Fixed dose combination tablet with danoprevir, single oral dose', 'armGroupLabels': ['DNV/r fixed dose combination']}, {'name': 'ritonavir', 'type': 'DRUG', 'description': 'Reference tablet, single oral dose', 'armGroupLabels': ['DNV + r reference']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8011', 'city': 'Christchurch', 'country': 'New Zealand', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}