Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2026-01-05 @ 5:34 PM
Study NCT ID:
NCT02106767
Status:
COMPLETED
Last Update Posted:
2020-01-23
First Post:
2014-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Rifampin on the Pharmacokinetics of Rosuvastatin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}, {'id': 'D012293', 'term': 'Rifampin'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2016-08-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-21', 'studyFirstSubmitDate': '2014-04-03', 'studyFirstSubmitQcDate': '2014-04-07', 'lastUpdatePostDateStruct': {'date': '2020-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area-under-the-concentration curve (AUC) of rosuvastatin', 'timeFrame': 'Blood samples collected over a 48 hour period'}], 'secondaryOutcomes': [{'measure': 'Maximum plasma concentration (Cmax) of rosuvastatin', 'timeFrame': '0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 32, and 48 hours post-dose'}, {'measure': 'Time to concentration maximum (Tmax) of rosuvastatin', 'timeFrame': '0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 32, and 48 hours post-dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['rosuvastatin', 'rifampin', 'pharmacokinetics', 'drug interaction', 'healthy volunteer', 'drug transporter', 'Asian', 'White'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The effect of transporter inhibition by rifampin on the pharmacokinetics of rosuvastatin will be studied in clinical trial in White and Asian healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy Asian volunteers of Han-Chinese/Japanese/Korean descent whose parents and grandparents are Han-Chinese/ Japanese/ Korean.\n* Healthy Caucasian volunteers of White/Caucasian/European-born descent whose parents and grandparents are White/Caucasian/European.\n* Male or female, ages 18-65 years old, with no current medical conditions or active diagnoses as determined by the study doctor based on history, physical exam, and laboratory evaluations.\n* Subjects who take no other medications two weeks prior to the study and during the time course of the study including prescription medications, over-the-counter medications, dietary supplements, or drugs of abuse.\n* Subjects with the following genotype: SLCO1B1\\*1a and ABCG2 421CC.\n* Subjects able to maintain adequate birth control during the study independent of hormonal contraceptive use.\n* Subjects able to abstain from grapefruit, grapefruit juice, oranges, orange juice, caffeinated beverages and/or alcoholic beverages from 7am the day before the study to completion of that study day.\n* Participants determined to have normal liver and kidney function as measured at baseline\n* BMI between 18.0 - 30 kg/m2\n* Subjects capable of fasting from food and beverages at least 8 hours prior to medication dosing.\n* Be able to read, speak, and understand English.\n* Subjects capable of providing informed consent and completing the requirements of the study.\n\nExclusion Criteria:\n\n* Subjects with active medical problems\n* Subjects on chronic prescription or OTC medication that cannot be stopped 2 weeks prior to and during the study.\n* Subjects incapable of multiple blood draws (HCT \\< 30mg/dL)\n* Subjects with a history of rhabdomyolysis\n* Subjects with a history of drug-related myalgias\n* Subjects with a history or diagnosis of hemorrhagic tendencies or blood dyscrasias\n* Subjects with a history of GI bleed or peptic ulcer disease\n* Subjects who smoke tobacco or have ongoing alcohol or illegal drug use\n* Subjects who are pregnant, lactating, or trying to conceive during the study period\n* Subjects allergic to rosuvastatin or rifampin or any known component of the medications\n* Anyone who in the opinion of the study investigators is unable to do the study'}, 'identificationModule': {'nctId': 'NCT02106767', 'briefTitle': 'The Effects of Rifampin on the Pharmacokinetics of Rosuvastatin', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'The Effects of Single-Dose Rifampin on the Pharmacokinetics of Rosuvastatin in Healthy White and Asian Volunteers', 'orgStudyIdInfo': {'id': '14-12970'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Rosuvastatin', 'interventionNames': ['Drug: Rosuvastatin']}, {'type': 'EXPERIMENTAL', 'label': 'Rifampin plus rosuvastatin', 'interventionNames': ['Drug: Rosuvastatin plus rifampin']}], 'interventions': [{'name': 'Rosuvastatin', 'type': 'DRUG', 'otherNames': ['Crestor'], 'description': 'Rosuvastatin 20mg po x1', 'armGroupLabels': ['Rosuvastatin']}, {'name': 'Rosuvastatin plus rifampin', 'type': 'DRUG', 'otherNames': ['Crestor', 'Rifadin', 'Rifampicin'], 'description': 'Rifampin 600mg IV infused over 30 minutes followed by rosuvastatin 20mg PO x1', 'armGroupLabels': ['Rifampin plus rosuvastatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'CTSI Clinical Research Center, UCSF', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Leslie Z Benet, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}, {'name': 'Lynda Frassetto, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}