Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT01592305
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2012-04-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Drug-Drug Interaction Between Danoprevir Coadministered With Low-Dose Ritonavir and Tenofovir Disoproxil Fumarate or Atazanavir
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069446', 'term': 'Atazanavir Sulfate'}, {'id': 'C553752', 'term': 'danoprevir'}, {'id': 'D019438', 'term': 'Ritonavir'}, {'id': 'D000068698', 'term': 'Tenofovir'}], 'ancestors': [{'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, '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': 'Pharmacokinetics of tenofovir disoproxil fumarate and atazanavir when coadministered with danoprevir/ritonavir: Area under the concentration-time curve (AUC)', 'timeFrame': 'Pre-dose, and up to 48 hours post-dose Days 1, 8, 11, 16, 20'}, {'measure': 'Pharmacokinetics of danoprevir and ritonavir when coadministered with tenofovir disoproxil fumarate and atazanavir: Area under the concentration-time curve (AUC)', 'timeFrame': 'Pre-dose, and up to 24 hours post-dose Days 10, 11, 16, 20'}], 'secondaryOutcomes': [{'measure': 'Safety: Incidence of adverse events', 'timeFrame': 'approximately 2 months'}]}, 'conditionsModule': {'conditions': ['Healthy Volunteer']}, 'descriptionModule': {'briefSummary': 'This randomized, open-label, multiple-treatment multiple-dose, 2-period, 2-sequence study will evaluate potential drug-drug interactions between danoprevir (DNV) when coadministered with low-dose ritonavir (r) and tenofovir disoproxil fumarate (TDF) or atazanavir (ATZ) in healthy volunteers. Subjects will be randomized to receive in Period 1 either single oral doses of TDF and multiple oral doses of DNV/r or multiple oral doses of ATZ/r. In Period 2, all subjects will receive multiple oral doses of DNV/r plus ATZ. Anticipated time on study treatment is up to 20 days.'}, '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, inclusive\n* Body weight \\>/= 55 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 disease or condition\n* Positive for drugs of abuse at screening or prior to admission to the clinical site\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 pill, patches, or 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 allergy reaction\n* History (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average'}, 'identificationModule': {'nctId': 'NCT01592305', 'briefTitle': 'A Study of Drug-Drug Interaction Between Danoprevir Coadministered With Low-Dose Ritonavir and Tenofovir Disoproxil Fumarate or Atazanavir', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Study to Evaluate the Potential Drug-Drug Interaction Between Danoprevir When Coadministered With Low-Dose Ritonavir and Tenofovir Disoproxil Fumarate or Atazanavir in Healthy Adult Volunteers', 'orgStudyIdInfo': {'id': 'NP28104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'S1 P1 TDF + DNV/r', 'interventionNames': ['Drug: danoprevir', 'Drug: ritonavir', 'Drug: tenofovir disoproxil fumarate']}, {'type': 'EXPERIMENTAL', 'label': 'S1/S2 P2 DNV/r + ATZ', 'interventionNames': ['Drug: atazanavir', 'Drug: danoprevir', 'Drug: ritonavir']}, {'type': 'EXPERIMENTAL', 'label': 'S2 P1 ATZ/r', 'interventionNames': ['Drug: atazanavir', 'Drug: ritonavir']}], 'interventions': [{'name': 'atazanavir', 'type': 'DRUG', 'description': 'multiple oral doses', 'armGroupLabels': ['S1/S2 P2 DNV/r + ATZ', 'S2 P1 ATZ/r']}, {'name': 'danoprevir', 'type': 'DRUG', 'description': 'multiple oral doses', 'armGroupLabels': ['S1 P1 TDF + DNV/r', 'S1/S2 P2 DNV/r + ATZ']}, {'name': 'ritonavir', 'type': 'DRUG', 'description': 'multiple oral doses', 'armGroupLabels': ['S1 P1 TDF + DNV/r', 'S1/S2 P2 DNV/r + ATZ', 'S2 P1 ATZ/r']}, {'name': 'tenofovir disoproxil fumarate', 'type': 'DRUG', 'description': 'single oral doses', 'armGroupLabels': ['S1 P1 TDF + DNV/r']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66219', 'city': 'Lenexa', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 38.95362, 'lon': -94.73357}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}