Ignite Creation Date:
2025-12-26 @ 11:12 PM
Ignite Modification Date:
2026-02-25 @ 5:33 PM
Study NCT ID:
NCT01582412
Status:
COMPLETED
Last Update Posted:
2015-09-01
First Post:
2012-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug Interaction Study of Isavuconazole and Digoxin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C508735', 'term': 'isavuconazole'}, {'id': 'D004077', 'term': 'Digoxin'}], 'ancestors': [{'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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-31', 'studyFirstSubmitDate': '2012-04-19', 'studyFirstSubmitQcDate': '2012-04-19', 'lastUpdatePostDateStruct': {'date': '2015-09-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic (PK) profile for digoxin (in plasma):AUCinf, AUClast, Cmax', 'timeFrame': 'Days 1 and 19', 'description': 'Area under the concentration-time curve (AUC) from time 0 extrapolated to infinity (AUCinf), AUC from time of dosing to the last quantifiable concentration (AUClast), and maximum concentration(Cmax)'}], 'secondaryOutcomes': [{'measure': 'PK profile for digoxin (in plasma): tmax, Vz/F, CL/F, and t1/2', 'timeFrame': 'Days 1 and 19', 'description': 'Time to attain Cmax(tmax), apparent volume of distribution (Vz/F), apparent body clearance after oral dosing (CL/F), and apparent terminal elimination half-life (t1/2)'}, {'measure': 'PK Isavuconazole (in plasma): trough concentration (Ctrough)', 'timeFrame': 'Day 17 and Days 21 through 27'}, {'measure': 'PK profile for Isavuconazole (in plasma): AUCtau, Cmax, and tmax', 'timeFrame': 'Days 18 and 19', 'description': 'AUC during time interval between consecutive dosing (AUCtau), maximum concentration (Cmax),and time to attain Cmax (tmax)'}, {'measure': 'Safety assessed by recording of adverse events, clinical laboratory evaluation, electrocardiograms (ECGs) and vital signs.', 'timeFrame': 'Day 1 through Day 34 (± 2 days)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Isavuconazole', 'Digoxin', 'Healthy Volunteers', 'BAL8557'], 'conditions': ['Pharmacokinetics of Isavuconazole', 'Pharmacokinetics of Digoxin', 'Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics of a single dose of digoxin in healthy adult subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The subject has a body weight of at least 45 kg and has a body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive\n* Results for aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be ≤ upper limit of normal and total bilirubin must be ≤ 1.5 mg/dL\n* The female subject agrees to sexual abstinence, or is surgically sterile, postmenopausal (defined as at least 2 years at Screening without menses), or using a medically acceptable double barrier method (e.g. spermicide and diaphragm, or spermicide and condom) to prevent pregnancy and agrees to continue using this method from Screening until 3 weeks after the follow-up visit at the end of the study; and is not lactating or pregnant as documented by negative pregnancy tests at Screening and Day -1\n* The male subject agrees to sexual abstinence, is surgically sterile, or is using a medically acceptable method to prevent pregnancy and agrees to continue using this method from Screening until 3 weeks after the follow-up visit at the end of the study\n\nExclusion Criteria:\n\n* The subject has a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmia or torsade de pointes, structural heart disease, or family history of Long QT syndrome (suggested by sudden death of a close relative at a young age due to possible or probable cardiac causes)\n* The subject has a positive result for hepatitis C antibodies or hepatitis B surface antigen at Screening or is known to be positive for human immunodeficiency virus (HIV)\n* The subject has a known or suspected allergy to any of the components of the trial products including digoxin or the azole class of compounds, or a history of multiple and/or severe allergies to drugs or foods (as judged by the investigator), or a history of severe anaphylactic reactions\n* The subject is a smoker (any use of tobacco or nicotine containing products) within 6 months prior to Screening\n* The subject has had treatment with prescription drugs or complementary and alternative medicines within 14 days prior to Day -1, or over-the-counter medications within 1 week prior to Day -1, with the exception of acetaminophen up to 2 g/day\n* The subject has a recent history (within the last 2 years) of drug or alcohol abuse, as defined by the investigator, or a positive drug and/or alcohol screen'}, 'identificationModule': {'nctId': 'NCT01582412', 'briefTitle': 'Drug Interaction Study of Isavuconazole and Digoxin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'A Phase 1, Open-Label, Sequential Study of the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of a Single Dose of Digoxin in Healthy Adult Subjects', 'orgStudyIdInfo': {'id': '9766-CL-0025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Isavuconazole and digoxin', 'description': 'Isavuconazole three times per day (TID) on Days 15 and 16, and once daily (QD) on Days 17 thru 26. Digoxin single dose on Days 1 and 19.', 'interventionNames': ['Drug: Isavuconazole', 'Drug: digoxin']}], 'interventions': [{'name': 'Isavuconazole', 'type': 'DRUG', 'otherNames': ['BAL8557'], 'description': 'oral', 'armGroupLabels': ['Isavuconazole and digoxin']}, {'name': 'digoxin', 'type': 'DRUG', 'otherNames': ['Lanoxin®'], 'description': 'oral', 'armGroupLabels': ['Isavuconazole and digoxin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21225', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Parexel International', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Astellas Pharma Global Development'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Global Development, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Basilea Pharmaceutica International Ltd', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}