Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2026-02-18 @ 12:51 PM
Study NCT ID:
NCT01398293
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2011-07-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Danoprevir in Combination With Low-Dose Ritonavir in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C553752', 'term': 'danoprevir'}, {'id': 'D000077266', 'term': 'Moxifloxacin'}, {'id': 'D019438', 'term': 'Ritonavir'}], 'ancestors': [{'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2011-07-19', 'studyFirstSubmitQcDate': '2011-07-19', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Threshold pharmacological effect on cardiac repolarization as detected by changes in the QT/QTc interval following single dose', 'timeFrame': 'approximately 9 weeks'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics: Plasma concentrations', 'timeFrame': 'approximately 9 weeks'}, {'measure': 'Safety: Incidence of adverse events', 'timeFrame': 'approximately 9 weeks'}, {'measure': 'Cardiac response: Electrocardiogram (ECG)', 'timeFrame': 'approximately 9 weeks'}, {'measure': 'Correlation between pharmacokinetics (plasma concentrations) and QT/QTc interval changes', 'timeFrame': 'approximately 9 weeks'}]}, 'conditionsModule': {'conditions': ['Healthy Volunteer']}, 'descriptionModule': {'briefSummary': 'This single-dose, randomized, double-blind, double-dummy, placebo-controlled, positive-controlled four-way crossover study will evaluate the effect of a single dose of danoprevir with low-dose ritonavir on the QC/QTc interval in healthy volunteers. Subjects will be randomly assigned to one of four sequences with treatments of A: therapeutic dose of danoprevir plus ritonavir (DNV/r), B: supratherapeutic dose of DNV/r, C: moxifloxacin and D: placebo, with a washout period of at least 7 days between treatments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult healthy volunteers, 18 - 60 years of age\n* Female subjects must be surgically sterile or post-menopausal\n* Male subjects and their partners of child-bearing potential must use to methods of contraception for the duration of the study and for three months after the last drug administration\n* Agree to abstain from strenuous exercise for three days before dosing and throughout the study (including washout period and follow-up visit)\n\nExclusion Criteria:\n\n* History or evidence of any clinically significant disease or disorder\n* Pregnant or lactating women\n* Male partners of women who are lactating or trying to become pregnant\n* Current smokers or subjects who have discontinued smoking less than six months prior to first dosing\n* Positive alcohol breath test; suspicion of regular consumption of drugs of abuse\n* Positive for hepatitis B, hepatitis C or HIV infection\n* Participation in an investigational drug, biologic, or device study within three months before first study drug administration'}, 'identificationModule': {'nctId': 'NCT01398293', 'briefTitle': 'A Study of Danoprevir in Combination With Low-Dose Ritonavir in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Single-center, Single-dose, Randomized, Double-blind, Double-dummy, Placebo-controlled, Positive-controlled, Four-way Crossover Study to Investigate the Effect of Danoprevir With Low Dose Ritonavir (DNV/r) on the QT/QTc Interval in Healthy Subjects', 'orgStudyIdInfo': {'id': 'NP25298'}, 'secondaryIdInfos': [{'id': '2011-001413-13', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'interventionNames': ['Drug: danoprevir', 'Drug: moxifloxacin placebo', 'Drug: ritonavir']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'interventionNames': ['Drug: danoprevir', 'Drug: moxifloxacin placebo', 'Drug: ritonavir']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'C', 'interventionNames': ['Drug: danoprevir placebo', 'Drug: moxifloxacin', 'Drug: ritonavir placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'D', 'interventionNames': ['Drug: danoprevir placebo', 'Drug: moxifloxacin placebo', 'Drug: ritonavir placebo']}], 'interventions': [{'name': 'danoprevir', 'type': 'DRUG', 'description': '100 mg single dose orally', 'armGroupLabels': ['A']}, {'name': 'danoprevir', 'type': 'DRUG', 'description': '400 mg single dose orally', 'armGroupLabels': ['B']}, {'name': 'danoprevir placebo', 'type': 'DRUG', 'description': 'single oral dose', 'armGroupLabels': ['C', 'D']}, {'name': 'moxifloxacin', 'type': 'DRUG', 'description': '400 mg single dose orally', 'armGroupLabels': ['C']}, {'name': 'moxifloxacin placebo', 'type': 'DRUG', 'description': 'single oral dose', 'armGroupLabels': ['A', 'B', 'D']}, {'name': 'ritonavir', 'type': 'DRUG', 'description': '100 mg single dose orally', 'armGroupLabels': ['A', 'B']}, {'name': 'ritonavir placebo', 'type': 'DRUG', 'description': 'single oral dose', 'armGroupLabels': ['C', 'D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67064', 'city': 'Strasbourg', 'country': 'France', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}