Ignite Creation Date:
2025-12-24 @ 2:25 PM
Ignite Modification Date:
2025-12-26 @ 11:04 AM
Study NCT ID:
NCT03801759
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 Digoxin, Adefovir and Furosemide
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000624313', 'term': 'vadadustat'}, {'id': 'D005665', 'term': 'Furosemide'}, {'id': 'C053001', 'term': 'adefovir'}, {'id': 'D004077', 'term': 'Digoxin'}], 'ancestors': [{'id': 'D013424', 'term': 'Sulfanilamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D004071', 'term': 'Digitalis Glycosides'}, {'id': 'D002298', 'term': 'Cardenolides'}, {'id': 'D002301', 'term': 'Cardiac Glycosides'}, {'id': 'D002297', 'term': 'Cardanolides'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Each arm has fixed sequence design.\n\n1. Arm 1 (n = 20): Digoxin 0.5 mg alone, vadadustat 600 mg alone and digoxin + vadadustat\n2. Arm 2 (n = 16): adefovir 10mg alone, vadadustat 600 mg QD alone and adefovir + vadadustat\n3. Arm 3 (n=22) : furosemide 40mg alone, vadadustat 600 mg QD alone, and furosemide + vadadustat'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-09-30', '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': '2018-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under plasma concentration-time curve from 0 to last quantifiable concentration (AUClast) for digoxin, adefovir and furosemide', 'timeFrame': 'Up to 12 Weeks'}, {'measure': 'Area under plasma concentration-time curve from 0 to infinity (AUCinf) for digoxin, adefovir and furosemide', 'timeFrame': 'Up to 12 Weeks'}, {'measure': 'Maximum observed plasma concentration (Cmax) for digoxin, adefovir and furosemide', 'timeFrame': 'Up to 12 Weeks'}], 'secondaryOutcomes': [{'measure': 'Time to maximum observed plasma concentration (Tmax) for digoxin, adefovir and furosemide', 'timeFrame': 'Up to 12 Weeks'}, {'measure': 'Elimination rate constant (Kel) for digoxin, adefovir and furosemide', 'timeFrame': 'Up to 12 Weeks'}, {'measure': 'Terminal half-life (t½) for digoxin, adefovir and furosemide', 'timeFrame': 'Up to 12 Weeks'}, {'measure': 'Apparent total body clearance (CL/F) for digoxin, adefovir and furosemide', 'timeFrame': 'Up to 12 Weeks'}, {'measure': 'Percent of extrapolated area under the curve from time t to infinity (%AUCextrap) for digoxin, adefovir and furosemide', 'timeFrame': 'Up to 12 Weeks'}, {'measure': 'Reporting of Treatment Emergent Adverse Events (TEAEs) as reported by study subjects', 'timeFrame': 'Up to 12 Weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vadadustat', 'drug interactions', 'healthy volunteers'], 'conditions': ['Drug Interaction Potentiation']}, 'descriptionModule': {'briefSummary': 'This is a Phase 1, open-label, 3-arm, fixed sequence, study to evaluate vadadustat as a perpetrator of drug-drug interactions (DDIs) with digoxin, adefovir and furosemide in healthy male and female subjects.', 'detailedDescription': 'This is a Phase 1, open-label, 3-arm, fixed sequence, study to evaluate vadadustat as a perpetrator of drug-drug interactions (DDIs) with digoxin, adefovir and furosemide in healthy male and female subjects. Unique subjects will be enrolled into each arm of the study and enrollment will be sequential. The first 20 subjects confirmed to be eligible will be assigned to Arm 1 (digoxin), the next 16 subjects will be assigned to Arm 2 (adefovir) and the next 22 subjects will be assigned to Arm 3 (furosemide). Blood samples for PK analysis will be collected at pre-defined timepoints for each arm throughout the study. Subjects will be on study for up to 80 days, including a 28-day screening period, 7-21 day in clinic period, and a 30-day follow up period post last dose.'}, '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.\n* Positive test results for human immunodeficiency virus (HIV) antibody; 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': 'NCT03801759', 'briefTitle': 'Drug-Drug Interaction Study of Vadadustat With Digoxin, Adefovir and Furosemide', 'organization': {'class': 'INDUSTRY', 'fullName': 'Akebia Therapeutics'}, 'officialTitle': 'A Phase 1 Open-label, Three Arm Study in Healthy Adult Volunteers to Assess Vadadustat as a Perpetrator in Drug-Drug-Interactions With Digoxin, Adefovir and Furosemide', 'orgStudyIdInfo': {'id': 'AKB-6548-CI-0031'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vadadustat, digoxin', 'description': 'Arm 1: Subjects will receive a single oral dose of digoxin 0.5 mg alone, followed by a washout period and repeat doses of vadadustat 600 mg QD alone and in combination with a single dose of digoxin 0.5 mg.', 'interventionNames': ['Drug: Vadadustat', 'Drug: Digoxin']}, {'type': 'EXPERIMENTAL', 'label': 'Vadadustat, adefovir', 'description': 'Arm 2: Subjects will receive a single dose of oral adefovir 10 mg alone, followed by a washout period and repeat doses of vadadustat 600 mg QD alone and in combination with a single dose of adefovir.', 'interventionNames': ['Drug: Vadadustat', 'Drug: Adefovir']}, {'type': 'EXPERIMENTAL', 'label': 'Vadadustat, Furosemide', 'description': 'Arm 3: Subjects will receive a single dose of oral furosemide 40 mg alone, followed by a washout period and repeat doses of vadadustat 600 mg QD alone, and in combination with a single dose of furosemide 40 mg.', 'interventionNames': ['Drug: Vadadustat', 'Drug: Furosemide']}], 'interventions': [{'name': 'Vadadustat', 'type': 'DRUG', 'otherNames': ['AKB 6548'], 'description': 'Oral dose 600 mg', 'armGroupLabels': ['Vadadustat, Furosemide', 'Vadadustat, adefovir', 'Vadadustat, digoxin']}, {'name': 'Furosemide', 'type': 'DRUG', 'description': 'Oral Furosemide', 'armGroupLabels': ['Vadadustat, Furosemide']}, {'name': 'Adefovir', 'type': 'DRUG', 'description': 'Oral Adefovir', 'armGroupLabels': ['Vadadustat, adefovir']}, {'name': 'Digoxin', 'type': 'DRUG', 'description': 'Oral Digoxin', 'armGroupLabels': ['Vadadustat, digoxin']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1P 0A2', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'inVentiv Health Clinique Inc.', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'Akebia Therapeutics', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sponsor GmbH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Akebia Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}