Ignite Creation Date:
2025-12-26 @ 4:04 PM
Ignite Modification Date:
2025-12-26 @ 4:04 PM
Study NCT ID:
NCT01714206
Status:
COMPLETED
Last Update Posted:
2012-11-19
First Post:
2012-10-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Assess the Effects of Canagliflozin (JNJ-28431754) on the Pharmacokinetics and Safety of Digoxin in Healthy Volunteers.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004077', 'term': 'Digoxin'}, {'id': 'D000068896', 'term': 'Canagliflozin'}], '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'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-16', 'studyFirstSubmitDate': '2012-10-23', 'studyFirstSubmitQcDate': '2012-10-24', 'lastUpdatePostDateStruct': {'date': '2012-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma concentration of digoxin', 'timeFrame': 'Days 5 through 7', 'description': 'Comparison of plasma concentrations of digoxin following administration of digoxin alone (Treatment A) or in combination with canagliflozin (JNJ-28431754) (Treatment B). This will be used to determine whether there is a pharmacokinetic interaction between digoxin and canagliflozin.'}, {'measure': 'Urine concentration of digoxin', 'timeFrame': 'Day 7', 'description': 'Comparison of the urine concentrations of digoxin following administration of digoxin alone (Treatment A) or in combination with canagliflozin (JNJ-28431754) (Treatment B). This will be used to determine whether there is a pharmacokinetic interaction between canagliflozin and digoxin.'}], 'secondaryOutcomes': [{'measure': 'There are no secondary outcome measures'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Healthy', 'Canagliflozin (JNJ-28431754)', 'Pharmacokinetics', 'Digoxin (LANOXIN)'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '25345427', 'type': 'DERIVED', 'citation': 'Devineni D, Manitpisitkul P, Vaccaro N, Bernard A, Skee D, Mamidi RN, Tian H, Weiner S, Stieltjes H, Sha S, Rothenberg P. Effect of canagliflozin, a sodium glucose co-transporter 2 inhibitor, on the pharmacokinetics of oral contraceptives, warfarin, and digoxin in healthy participants. Int J Clin Pharmacol Ther. 2015 Jan;53(1):41-53. doi: 10.5414/CP202157.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine how multiple doses of canagliflozin (JNJ-28431754) affect the pharmacokinetics (ie, how the body affects the drug) of multiple doses of digoxin. The safety and tolerability of canagliflozin will also be assessed in healthy volunteers.', 'detailedDescription': 'This study will be an open label (all volunteers and study staff know the identity of the assigned treatment), randomized (the treatment is assigned by chance), multiple dose, cross-over study (all volunteers will switch from one treatment to another) to determine how canagliflozin (a drug currently being investigated for the treatment of type 2 diabetes mellitus) affects the pharmacokinetics of digoxin (a drug used to treat various heart conditions). Volunteers will be randomly assigned to 1 of 2 treatment sequence groups: Group AB or Group BA. Volunteers assigned to Group AB will be given Treatment A: digoxin once a day for 7 days. Volunteers assigned to Group BA will be given Treatment B: digoxin and canagliflozin once a day for 7 days. A washout period (when no medication is given) of at least 14 days will follow the first 7-day treatment period. Following the washout period, volunteers will be assigned to the treatment that they did not receive during the first treatment period. This second treatment period will last for 7 days. Each volunteer will participate in the study for approximately 60 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Volunteers must have a body mass index (BMI = weight in kg/height in m2) between 18 and 30 kg/m2 (inclusive), and body weight not less than 50 kg\n* Exclusion Criteria:\n* History of, or current active illness, considered to be clinically significant by the Investigator, or any other illness that the Investigator considers should exclude the patient from the study, or that could interfere with the interpretation of the study results'}, 'identificationModule': {'nctId': 'NCT01714206', 'briefTitle': 'A Study to Assess the Effects of Canagliflozin (JNJ-28431754) on the Pharmacokinetics and Safety of Digoxin in Healthy Volunteers.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.'}, 'officialTitle': 'An Open-Label, 2-Period, Crossover Study to Evaluate the Effects of Multiple Doses of JNJ-28431754 on the Pharmacokinetics of Multiple Doses of Digoxin in Healthy Subjects.', 'orgStudyIdInfo': {'id': 'CR016465'}, 'secondaryIdInfos': [{'id': '28431754DIA1014', 'type': 'OTHER', 'domain': 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment A', 'description': 'Each volunteer will receive digoxin once daily on Days 1 through 7.', 'interventionNames': ['Drug: Digoxin 0.5 mg', 'Drug: Digoxin 0.25 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment B', 'description': 'Each volunteer will receive digoxin once daily on Days 1 through 7 in combination with canagliflozin (JNJ-28431754) once daily on Days 1 through 7.', 'interventionNames': ['Drug: Digoxin 0.5 mg', 'Drug: Digoxin 0.25 mg', 'Drug: Canagliflozin (JNJ-28431754)']}], 'interventions': [{'name': 'Digoxin 0.5 mg', 'type': 'DRUG', 'otherNames': ['Lanoxin'], 'description': 'Two 0.25 mg tablets (0.5 mg total dose) taken orally (by mouth) on Day 1.', 'armGroupLabels': ['Treatment A', 'Treatment B']}, {'name': 'Digoxin 0.25 mg', 'type': 'DRUG', 'otherNames': ['Lanoxin'], 'description': 'One 0.25 mg tablet taken orally on Days 2 through 7.', 'armGroupLabels': ['Treatment A', 'Treatment B']}, {'name': 'Canagliflozin (JNJ-28431754)', 'type': 'DRUG', 'otherNames': ['JNJ-28431754'], 'description': 'One 300 mg tablet taken orally on Days 1 through 7.', 'armGroupLabels': ['Treatment B']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}