Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-31 @ 5:33 PM
Study NCT ID:
NCT03801733
Status:
COMPLETED
Last Update Posted:
2019-03-22
First Post:
2018-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug-Drug Interaction Study of Vadadustat With Rosuvastatin, Sulfasalazine, Pravastatin, Atorvastatin and Simvastatin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000624313', 'term': 'vadadustat'}, {'id': 'D019821', 'term': 'Simvastatin'}, {'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}, {'id': 'D000069059', 'term': 'Atorvastatin'}, {'id': 'D017035', 'term': 'Pravastatin'}, {'id': 'D012460', 'term': 'Sulfasalazine'}], 'ancestors': [{'id': 'D008148', 'term': 'Lovastatin'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'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': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'This is a three-part sequential design study. Part 2 will be initiated based upon the outcome of Part 1 and Part 3 will be initiated after completion of Part 2.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 134}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-11-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-20', 'studyFirstSubmitDate': '2018-12-27', 'studyFirstSubmitQcDate': '2019-01-09', 'lastUpdatePostDateStruct': {'date': '2019-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under plasma concentration-time curve from time 0 to last quantifiable concentration (AUClast) of rosuvastatin, sulfasalazine, pravastatin and simvastatin', 'timeFrame': 'Up to 10 weeks'}, {'measure': 'Area under plasma concentration-time curve from time 0 to infinity (AUCinf) of rosuvastatin, sulfasalazine, pravastatin and simvastatin', 'timeFrame': 'Up to 10 weeks'}, {'measure': 'Maximum observed plasma concentration (Cmax) of rosuvastatin. sulfasalazine, pravastatin, atorvastatin and simvastatin', 'timeFrame': 'Up to 10 weeks'}, {'measure': 'Area under plasma concentration-time curve (AUCtau) of atorvastatin', 'timeFrame': 'Up to 10 weeks'}], 'secondaryOutcomes': [{'measure': 'Time to maximum observed plasma concentration (Tmax) of rosuvastatin, sulfasalazine, pravastatin, atorvastatin, and simvastatin', 'timeFrame': 'Up to 10 weeks'}, {'measure': 'Elimination rate constant (Kel) of rosuvastatin, sulfasalazine, pravastatin, atorvastatin, and simvastatin', 'timeFrame': 'Up to 10 weeks'}, {'measure': 'Terminal half-life (t½) of rosuvastatin, sulfasalazine, pravastatin, atorvastatin, and simvastatin', 'timeFrame': 'Up to 10 weeks'}, {'measure': 'Apparent total body clearance (CL/F) of rosuvastatin, sulfasalazine, pravastatin, atorvastatin, and simvastatin', 'timeFrame': 'Up to 10 weeks'}, {'measure': 'Percentage of extrapolated area under the curve from time t to infinity (%AUCextrap or Residual Area) of rosuvastatin, sulfasalazine, pravastatin, atorvastatin, and simvastatin', 'timeFrame': 'Up to 10 weeks'}, {'measure': 'Area under plasma concentration-time curve from time 0 to last quantifiable concentration (AUClast) of sulfasalazine metabolites, sulfapyridine and 5-ASA (mesalamine', 'timeFrame': 'Up to 10 weeks'}, {'measure': 'Area under plasma concentration-time curve from time 0 to infinity (AUCinf) of sulfasalazine metabolites, sulfapyridine and 5-ASA (mesalamine', 'timeFrame': 'Up to 10 weeks'}, {'measure': 'Maximum observed plasma concentration (Cmax) of sulfasalazine metabolites, sulfapyridine and 5-ASA (mesalamine', 'timeFrame': 'Up to 10 weeks'}, {'measure': 'Time to maximum observed plasma concentration (Tmax) of sulfasalazine metabolites, sulfapyridine and 5-ASA (mesalamine', 'timeFrame': 'Up to 10 weeks'}, {'measure': 'Elimination rate constant (Kel) of sulfasalazine metabolites, sulfapyridine and 5-ASA (mesalamine', 'timeFrame': 'Up to 10 weeks'}, {'measure': 'Terminal half-life (t½) of sulfasalazine metabolites, sulfapyridine and 5-ASA (mesalamine', 'timeFrame': 'Up to 10 weeks'}, {'measure': 'Area under the plasma concentration-time curve for a dosing interval (AUCtau) of atorvastatin metabolites, o-hydroxyatorvastatin; p-hydroxyatorvastatin', 'timeFrame': 'Up to 10 weeks'}, {'measure': 'Maximum observed plasma concentration (Cmax) of atorvastatin metabolites, o-hydroxyatorvastatin; p-hydroxyatorvastatin', 'timeFrame': 'Up to 10 weeks'}, {'measure': 'Time to maximum observed plasma concentration (Tmax) of atorvastatin metabolites, o-hydroxyatorvastatin; p-hydroxyatorvastatin', 'timeFrame': 'Up to 10 weeks'}, {'measure': 'Area under plasma concentration-time curve from time 0 to last quantifiable concentration (AUClast) of simvastatin metabolite', 'timeFrame': 'Up to 10 weeks'}, {'measure': 'Area under plasma concentration-time curve from time 0 to infinity (AUCinf) of simvastatin metabolite', 'timeFrame': 'Up to 10 weeks'}, {'measure': 'Maximum observed plasma concentration (Cmax) of simvastatin metabolite', 'timeFrame': 'Up to 10 weeks'}, {'measure': 'Time to maximum observed plasma concentration (Tmax) of simvastatin metabolite', 'timeFrame': 'Up to 10 weeks'}, {'measure': 'Elimination rate constant (Kel) of simvastatin metabolite', 'timeFrame': 'Up to 10 weeks'}, {'measure': 'Terminal half-life (t½), of simvastatin metabolite', 'timeFrame': 'Up to 10 weeks'}, {'measure': 'Reporting of treatment emergent adverse events (TEAE) as reported by the study subjects', 'timeFrame': 'Up to 10 weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vadadustat', 'Normal Healthy volunteers', 'Pharmacokinetics', 'Rosuvastatin', 'Sulfasalazine', 'Pravastatin', 'Atrovastatin', 'Simvastatin'], 'conditions': ['Drug Interaction Potentiation']}, 'descriptionModule': {'briefSummary': 'This is a Phase 1, three-part, open-label study to evaluate vadadustat as a perpetrator in drug-drug interactions with rosuvastatin, sulfasalazine, pravastatin, atorvastatin and simvastatin in healthy male and female subjects.', 'detailedDescription': 'This is a Phase 1, three-part, open-label study to evaluate vadadustat as a perpetrator in drug-drug interactions with rosuvastatin, sulfasalazine, pravastatin, atorvastatin, and simvastatin in healthy male and female subjects. Thirty-four (34) subjects will be enrolled in Part 1 (rosuvastatin) and based on review of the PK and safety/tolerability data, a decision will be made on whether to proceed with Part 2. Part 2 consists of 2 arms (sulfasalazine and pravastatin). Twenty-six (26) subjects will be enrolled into each arm. Part 3 consists of 2 arms (atorvastatin and simvastatin). Twenty-four (24) subjects will be enrolled into each arm after enrollment in Part 2 is completed. Subjects will be in the study for up to 72 days, including a 28-day screening period, 6-14 day in clinic period, and a 30-day follow up period post last dose. Blood samples for PK analysis will be collected at pre-defined time points throughout the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy Male or female between 18 and 55 years of age, inclusive, at time of informed consent\n* Body mass index between 18.0 and 30.0 kg/m2, with a minimum body weight of 45 kg for females and 50 kg for males, inclusive.\n\nExclusion Criteria:\n\n* Current or past clinically significant history of cardiovascular, cerebrovascular, pulmonary, gastrointestinal, hematologic, renal, hepatic, immunologic, metabolic, urologic, neurologic, dermatologic, psychiatric, or other major disease. History of cancer (except treated non-melanoma skin cancer) or history of chemotherapy use within 5 years prior to Screening; History of latent or active tuberculosis (TB).\n* Positive test results for human immunodeficiency virus (HIV) antibody; 12. Positive test results of hepatitis B surface antigen (HBsAg), or positive hepatitis C virus antibody (HCVab) within 3 months prior to screening, or positive test results for human immunodeficiency virus antibody (HIVab) at Screening\n* Taking any prescription medication or over the counter multi-vitamin supplement, or any non-prescription products (including herbal-containing preparations but excluding acetaminophen) within 14 days prior to Day -1.'}, 'identificationModule': {'nctId': 'NCT03801733', 'briefTitle': 'Drug-Drug Interaction Study of Vadadustat With Rosuvastatin, Sulfasalazine, Pravastatin, Atorvastatin and Simvastatin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Akebia Therapeutics'}, 'officialTitle': 'A Phase 1, Three-Part, Open-label Study in Healthy Adult Volunteers to Assess Vadadustat as a Perpetrator in Drug-Drug Interactions With Rosuvastatin, Sulfasalazine, Pravastatin, Atorvastatin and Simvastatin', 'orgStudyIdInfo': {'id': 'AKB 6548 CI 0030'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rosuvastatin, Vadadustat', 'description': 'Part 1: Subjects will receive rosuvastatin 20 mg alone, vadadustat 600 mg alone, followed by rosuvastatin 20 mg in combination with vadadustat 600 mg in a fixed-sequence dosing design.', 'interventionNames': ['Drug: Vadadustat', 'Drug: Rosuvastatin']}, {'type': 'EXPERIMENTAL', 'label': 'Sulfasalazine. Pravastatin, Vadadustat', 'description': 'Part 2, Arm 1: Subjects will receive sulfasalazine 500 mg alone followed by sulfasalazine 500 mg in combination with vadadustat 600 mg once a day in a fixed-sequence dosing design.\n\nPart 2, Arm 2: Subjects will receive pravastatin 40 mg alone followed by pravastatin 40 mg in combination with vadadustat 600 mg once a day in a fixed-sequence dosing design.', 'interventionNames': ['Drug: Vadadustat', 'Drug: Pravastatin', 'Drug: Sulfasalazine']}, {'type': 'EXPERIMENTAL', 'label': 'Atorvastatin, Simvastatin, Vadadustat', 'description': 'Part 3, Arm 1: Subjects will receive atorvastatin 40 mg alone followed by atorvastatin 40 mg in combination with vadadustat 600 mg once a day in a fixed-sequence dosing design.\n\nPart 3, Arm 2: 24 subjects will receive simvastatin 40 mg alone followed by simvastatin 40 mg in combination with vadadustat 600 mg once a day in a fixed-sequence dosing design.', 'interventionNames': ['Drug: Vadadustat', 'Drug: Simvastatin', 'Drug: Atorvastatin']}], 'interventions': [{'name': 'Vadadustat', 'type': 'DRUG', 'otherNames': ['AKB 6548'], 'description': 'Oral dose of 600 mg QD', 'armGroupLabels': ['Atorvastatin, Simvastatin, Vadadustat', 'Rosuvastatin, Vadadustat', 'Sulfasalazine. Pravastatin, Vadadustat']}, {'name': 'Simvastatin', 'type': 'DRUG', 'description': 'Oral Simvastatin', 'armGroupLabels': ['Atorvastatin, Simvastatin, Vadadustat']}, {'name': 'Rosuvastatin', 'type': 'DRUG', 'description': 'Oral Rosuvastatin', 'armGroupLabels': ['Rosuvastatin, Vadadustat']}, {'name': 'Atorvastatin', 'type': 'DRUG', 'description': 'Oral Atorvastatin', 'armGroupLabels': ['Atorvastatin, Simvastatin, Vadadustat']}, {'name': 'Pravastatin', 'type': 'DRUG', 'description': 'Oral Pravastatin', 'armGroupLabels': ['Sulfasalazine. Pravastatin, Vadadustat']}, {'name': 'Sulfasalazine', 'type': 'DRUG', 'description': 'Oral Sulfasalazine', 'armGroupLabels': ['Sulfasalazine. Pravastatin, Vadadustat']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1P A02', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'InVentiv Health Clinique Inc.', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'Akebia Inc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Akebia Therapeutics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Akebia Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}