Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2026-01-01 @ 7:47 AM
Study NCT ID:
NCT01591850
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2012-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Drug-Drug Interaction Study of Ketoconazole, Rifampicin and Ritonavir-Boosted Atazanavir With Single-Dose RO5093151 in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069446', 'term': 'Atazanavir Sulfate'}, {'id': 'D007654', 'term': 'Ketoconazole'}, {'id': 'D012293', 'term': 'Rifampin'}, {'id': 'D019438', 'term': 'Ritonavir'}], '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': 'D010879', 'term': 'Piperazines'}, {'id': 'D012294', 'term': 'Rifamycins'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D047029', 'term': 'Lactams, Macrocyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2012-05-03', 'studyFirstSubmitQcDate': '2012-05-03', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part 1: Effect of multiple doses of ketoconazole on single-dose pharmacokinetics of RO5093151 and metabolites: Area under the concentration-time curve (AUC)', 'timeFrame': 'Pre-dose and up to 72 hours post-dose'}, {'measure': 'Part 2: Effect of multiple doses of rifampicin on single-dose pharmacokinetics of RO5093151 and metabolites: Area under the concentration-time curve (AUC)', 'timeFrame': 'Pre-dose and up to 72 hours post-dose'}, {'measure': 'Part 3: Effect of multiple doses of ritonavir-boosted atazanavir on single-dose pharmacokinetics of RO5093151 and metabolites: Area under the concentration-time curve (AUC)', 'timeFrame': 'Pre-dose and up to 72 hours post-dose'}], 'secondaryOutcomes': [{'measure': 'Safety: Incidence of adverse events', 'timeFrame': 'approximately 6 month'}, {'measure': 'RO5093151 metabolites: Plasma/urine concentrations', 'timeFrame': 'Pre-dose and up to 72 hours post-dose'}, {'measure': 'Pharmacodynamics: Area under the effect curve (AUEC) for plasma cortisol/cortisone (Part 1 only)', 'timeFrame': 'Pre-dose and up to 24 hours post-dose'}]}, 'conditionsModule': {'conditions': ['Healthy Volunteer']}, 'descriptionModule': {'briefSummary': 'This randomized, single-center, open-label, one-sequence, two-period crossover study in three parts will assess the effects of multiple doses of ketoconazole, rifampicin and ritonavir-boosted atazanavir on the pharmacokinetics of a single dose of RO5093151 in healthy male and female volunteers. In Period 1, subjects will receive a single oral dose of RO5093151. In Period 2, subjects will receive a single oral dose of RO5093151 and multiple oral doses of either ketoconazole, rifampicin or ritonavir-boosted atazanavir. Anticipated time on study is up to 8.5 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male and female subjects, 18 to 65 years of age. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history and complete physical examination\n* Body mass index (BMI) 18 to 30 kg/m2\n* Females of child-bearing potential must agree to use two effective methods of contraception, including a barrier method and an intrauterine non-hormonal device (set in place at least 3 months before first dosing) for the duration of the study and at least 1 month after last dosing\n* Non-smoker for at least 90 days prior to screening\n\nExclusion Criteria:\n\n* Pregnant or lactating females\n* History of drug abuse in the past 2 years, or suspicion of regular consumption of drugs of abuse, or positive result on drugs of abuse test\n* History of alcoholism in the past 2 years, or positive alcohol test\n* Positive for hepatitis B, hepatitis C or HIV infection\n* Systemic , topical, intranasal or inhaled corticosteroid therapy for more than 2 weeks within 3 months prior to screening\n* Participation in an investigational drug or device study within 90 days prior to screening'}, 'identificationModule': {'nctId': 'NCT01591850', 'briefTitle': 'A Drug-Drug Interaction Study of Ketoconazole, Rifampicin and Ritonavir-Boosted Atazanavir With Single-Dose RO5093151 in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Randomized, Single-center, Open-label, One-sequence, Two-period Crossover Study in 3 Parts to Investigate the Effects of Multiple Doses of Ketoconazole (Part 1), Rifampicin (Part 2), and Ritonavir-boosted Atazanavir (Part 3) on the PK of a Single Dose of RO5093151 in Healthy Female & Male Subjects', 'orgStudyIdInfo': {'id': 'BP27852'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1 Ketoconazole DDI', 'interventionNames': ['Drug: RO5093151', 'Drug: ketoconazole']}, {'type': 'EXPERIMENTAL', 'label': '2 Rifampicin DDI', 'interventionNames': ['Drug: RO5093151', 'Drug: rifampicin']}, {'type': 'EXPERIMENTAL', 'label': '3 ATZ/r DDI', 'interventionNames': ['Drug: RO5093151', 'Drug: atazanavir', 'Drug: ritonavir']}], 'interventions': [{'name': 'RO5093151', 'type': 'DRUG', 'description': 'Single oral dose', 'armGroupLabels': ['1 Ketoconazole DDI', '2 Rifampicin DDI', '3 ATZ/r DDI']}, {'name': 'atazanavir', 'type': 'DRUG', 'description': 'Multiple oral doses', 'armGroupLabels': ['3 ATZ/r DDI']}, {'name': 'ketoconazole', 'type': 'DRUG', 'description': 'Multiple oral doses', 'armGroupLabels': ['1 Ketoconazole DDI']}, {'name': 'rifampicin', 'type': 'DRUG', 'description': 'Multiple oral doses', 'armGroupLabels': ['2 Rifampicin DDI']}, {'name': 'ritonavir', 'type': 'DRUG', 'description': 'Multiple oral doses', 'armGroupLabels': ['3 ATZ/r DDI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32953', 'city': 'Merritt Island', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.359, 'lon': -80.69}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}