Ignite Creation Date:
2025-12-24 @ 7:30 PM
Ignite Modification Date:
2025-12-25 @ 5:11 PM
Study NCT ID:
NCT01286103
Status:
COMPLETED
Last Update Posted:
2012-03-13
First Post:
2011-01-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Pharmacokinetic and Pharmacodynamic Study of Once-Daily and Twice-Daily Dosing With Canagliflozin in Healthy Adult Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068896', 'term': 'Canagliflozin'}], 'ancestors': [{'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'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-12', 'studyFirstSubmitDate': '2011-01-13', 'studyFirstSubmitQcDate': '2011-01-27', 'lastUpdatePostDateStruct': {'date': '2012-03-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma concentrations of canagliflozin', 'timeFrame': 'Up to Day 5 after the last treatment'}, {'measure': 'Plasma concentrations of glucose', 'timeFrame': 'Up to Day 5 after the last treatment'}, {'measure': 'Urinary glucose excretion (UGE)', 'timeFrame': 'Up to Day 5 after the last treatment'}, {'measure': 'Renal threshold of glucose (RTG)', 'timeFrame': 'Up to Day 5 after the last treatment'}], 'secondaryOutcomes': [{'measure': 'The number and type of adverse events reported', 'timeFrame': 'Up to 10 days after last dose (last dose is given on Day 8)'}, {'measure': 'Changes in hematology laboratory parameters', 'timeFrame': 'Up to 10 days after last dose (last dose is given on Day 8)'}, {'measure': 'Changes in chemistry laboratory parameters', 'timeFrame': 'Up to 10 days after last dose (last dose is given on Day 8)'}]}, 'conditionsModule': {'keywords': ['Canagliflozin', 'Pharmacokinetics', 'Pharmacodynamics'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '25907176', 'type': 'DERIVED', 'citation': 'Devineni D, Polidori D, Curtin CR, Murphy J, Wang SS, Stieltjes H, Wajs E. Pharmacokinetics and pharmacodynamics of once- and twice-daily multiple-doses of canagliflozin, a selective inhibitor of sodium glucose co-transporter 2, in healthy participants. Int J Clin Pharmacol Ther. 2015 Jun;53(6):438-46. doi: 10.5414/CP202324.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effects of canagliflozin on glucose levels in the blood and urine when taken at 2 dose levels as a once-daily or twice-daily dosing regimen in healthy adult volunteers', 'detailedDescription': 'This is an open-label (volunteers will know the names of treatments they are assigned), single-center study of canagliflozin (JNJ-28431754) in healthy adult volunteers. Canagliflozin (a Sodium-Glucose Cotransporter 2 inhibitor) is currently under development to lower blood sugar levels in patients with type 2 diabetes mellitus (T2DM). Patients in Cohort 1 will be randomized to receive Treatment A (one 300-mg tablet orally, by mouth \\[PO\\] once daily for 5 days) followed 10 days later by Treatment B (one 50-mg and one 100-mg tablet PO twice daily for 5 days) or Treatment B followed by Treatment A. Patients in Cohort 2 will be randomized to receive Treatment C (one 100-mg tablet PO once daily for 5 days) followed 10 days later by Treatment D (one 50-mg tablet PO twice daily for 5 days) or Treatment D followed by Treatment C.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy volunteers with a body mass index (BMI, a measure of a person's weight in relation to height) between 18 and 30 kg/m2, inclusive, and a body weight of not less than 50 kg\n\nExclusion Criteria:\n\n* History of or current clinically significant medical illness as determined by the Investigator\n* History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose\n* Known allergy to canagliflozin or any of the excipients of the formulation of canagliflozin"}, 'identificationModule': {'nctId': 'NCT01286103', 'briefTitle': 'A Pharmacokinetic and Pharmacodynamic Study of Once-Daily and Twice-Daily Dosing With Canagliflozin in Healthy Adult Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.'}, 'officialTitle': 'An Open-Label, Multiple-Dose Study to Assess the Steady-State Pharmacokinetics, Pharmacodynamics and Safety of Once-Daily Versus Twice-Daily Dosing With Canagliflozin in Healthy Subjects', 'orgStudyIdInfo': {'id': 'CR017824'}, 'secondaryIdInfos': [{'id': '28431754DIA1032'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '001', 'description': 'Canagliflozin 300 mg once daily and 150 mg twice daily Treatment A (one 300-mg tablet once daily for 5 days) followed 10 days later by Treatment B (one 50-mg and one 100-mg tablet twice daily for 5 days) or Treatment B followed by Treatment A.', 'interventionNames': ['Drug: Canagliflozin 300 mg once daily and 150 mg twice daily']}, {'type': 'EXPERIMENTAL', 'label': '002', 'description': 'Canagliflozin 100 mg once daily and 50 mg twice daily Treatment C (one 100-mg tablet once daily for 5 days) followed 10 days later by Treatment D (one 50-mg tablet twice daily for 5 days) or Treatment D followed by Treatment C.', 'interventionNames': ['Drug: Canagliflozin 100 mg once daily and 50 mg twice daily']}], 'interventions': [{'name': 'Canagliflozin 300 mg once daily and 150 mg twice daily', 'type': 'DRUG', 'description': 'Treatment A (one 300-mg tablet once daily for 5 days) followed 10 days later by Treatment B (one 50-mg and one 100-mg tablet twice daily for 5 days) or Treatment B followed by Treatment A.', 'armGroupLabels': ['001']}, {'name': 'Canagliflozin 100 mg once daily and 50 mg twice daily', 'type': 'DRUG', 'description': 'Treatment C (one 100-mg tablet once daily for 5 days) followed 10 days later by Treatment D (one 50-mg tablet twice daily for 5 days) or Treatment D followed by Treatment C.', 'armGroupLabels': ['002']}]}, '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': {'oldNameTitle': 'Director, Clinical Pharmacology Leader', 'oldOrganization': 'Johnson & Johnson Pharmaceutical Research and Development, L.L.C.'}}}}