Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2026-02-20 @ 4:32 PM
Study NCT ID:
NCT04023903
Status:
COMPLETED
Last Update Posted:
2020-02-05
First Post:
2019-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Pharmacology Study of Bardoxolone Methyl in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C445068', 'term': 'bardoxolone methyl'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-06-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-03', 'studyFirstSubmitDate': '2019-07-16', 'studyFirstSubmitQcDate': '2019-07-16', 'lastUpdatePostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 30, 36, 48, 60, 72, 96 hours'}, {'measure': 'AUC0-t', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 30, 36, 48, 60, 72, 96 hours'}], 'secondaryOutcomes': [{'measure': 'tmax', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 30, 36, 48, 60, 72, 96 hours'}, {'measure': 'AUC0-∞', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 30, 36, 48, 60, 72, 96 hours'}, {'measure': 't1/2', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 30, 36, 48, 60, 72, 96 hours'}, {'measure': 'MRT', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 30, 36, 48, 60, 72, 96 hours'}, {'measure': 'kel', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 30, 36, 48, 60, 72, 96 hours'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bardoxolone Methyl', 'Healthy subject', 'Food effect'], 'conditions': ['Healthy Subject']}, 'descriptionModule': {'briefSummary': 'Food effect part:\n\nTo investigate the effect of food on the pharmacokinetics of RTA 402 and evaluate the safety of RTA 402 in Japanese healthy male adults, using the capsule formulations.\n\nCaucasian subject part:\n\nTo investigate the pharmacokinetics of a single dose of RTA 402 administered in the fasted state and compare the pharmacokinetics with those observed in Japanese healthy male adults in the food effect part'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '20 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\) Written voluntary informed consent to participate in the study; 2) \\[Food Effect Part\\] Japanese men 20 to \\<40 years of age at informed consent; \\[Caucasian Subject Part\\] Caucasian men 20 to \\<40 years of age at informed consent; 3) BMI 18.5 kg/m2 to \\<25.0 kg/m2 at screening\n\nExclusion Criteria:\n\n1. Presence of any disease requiring treatment;\n2. History of heart failure (e.g., history of diagnosis of congestive heart failure categorized as Class III or IV of the New York Heart Association (NYHA) Functional Classification or history of hospitalization due to heart failure);\n3. Alcoholism or drug addiction, or any positive result on drug abuse testing;\n4. History of or current drug allergy;\n5. Any positive result on infectious disease testing. Individuals who are positive for active antibodies produced by hepatitis B vaccination and are not infected with hepatitis B virus at screening can be enrolled in the study;'}, 'identificationModule': {'nctId': 'NCT04023903', 'briefTitle': 'A Clinical Pharmacology Study of Bardoxolone Methyl in Healthy Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kyowa Kirin Co., Ltd.'}, 'officialTitle': 'A Clinical Pharmacology Study of RTA 402 (Investigation of the Effect of Food on the Pharmacokinetics of RTA 402 Capsules in Japanese Healthy Adults and Comparison of the Pharmacokinetics With Those in Caucasian Healthy Adults)', 'orgStudyIdInfo': {'id': 'RTA 402-009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RTA 402 5mg 3cap at fasting', 'interventionNames': ['Drug: Bardoxolone methyl']}, {'type': 'EXPERIMENTAL', 'label': 'RTA 402 5mg 3cap after meal', 'interventionNames': ['Drug: Bardoxolone methyl']}], 'interventions': [{'name': 'Bardoxolone methyl', 'type': 'DRUG', 'otherNames': ['RTA 402'], 'description': 'Bardoxolone methyl 5 mg capsules', 'armGroupLabels': ['RTA 402 5mg 3cap at fasting']}, {'name': 'Bardoxolone methyl', 'type': 'DRUG', 'otherNames': ['RTA 402'], 'description': 'Bardoxolone methyl 5 mg capsules', 'armGroupLabels': ['RTA 402 5mg 3cap after meal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '532-0003', 'city': 'Osaka', 'country': 'Japan', 'facility': 'Medical Corporation Heishinkai OPHAC Hospital', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyowa Kirin Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}