Ignite Creation Date:
2025-12-24 @ 5:15 PM
Ignite Modification Date:
2026-02-21 @ 11:18 PM
Study NCT ID:
NCT02174250
Status:
COMPLETED
Last Update Posted:
2024-04-25
First Post:
2014-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Rifampin on the Metabolism of Istradefylline in Healthy Volunteers.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C111599', 'term': 'istradefylline'}, {'id': 'D012293', 'term': 'Rifampin'}, {'id': 'C494814', 'term': 'BID protein, human'}], 'ancestors': [{'id': 'D012294', 'term': 'Rifamycins'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D047029', 'term': 'Lactams, Macrocyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-23', 'studyFirstSubmitDate': '2014-06-24', 'studyFirstSubmitQcDate': '2014-06-24', 'lastUpdatePostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the concentration-time curve from time zero to infinity (AUC0 ∞) and Observed maximum plasma concentration (Cmax) of istradefylline', 'timeFrame': 'Intermittently for a total of 62 days'}], 'secondaryOutcomes': [{'measure': 'Number of serious adverse events, and non-serious adverse events', 'timeFrame': 'Continuously for up to 74 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PD'], 'conditions': ["Parkinson's Disease"]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test whether Rifampin affects blood levels of istradefylline in humans. Rifampin could possibly decrease istradefylline levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy non-smoking male and post-menopausal female subjects\n* Body Mass Index: 18.0-35.0 kg/m2, inclusive\n* Subjects must not be taking drugs that are moderate to potent inhibitors of CYP3A4 or CYP1A2.\n* Subjects without clinically significant medical history in the judgment of the investigator\n* Subjects without clinically significant laboratory or ECG abnormalities\n\nExclusion Criteria:\n\n* Females that are pregnant or lactating\n* Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study;\n* Known history of treatment for drug or alcohol addiction within the previous 12 months;\n* Subjects with an average alcohol intake of more than 2 units per day or 14 units per week up to 48 hours prior to the istradefylline dose on Day 1. One unit of alcohol is ½ pint of beer (285 mL) or 1 glass of spirits (25 mL) or 1 glass of wine (125 mL);\n* Donated or lost \\> 500 mL of blood within 3 months prior to istradefylline dose on Day 1 of Period 1;\n* Positive test results for human immunodeficiency virus (HIV) or Hepatitis B surface antigen, or Hepatitis C;\n* Positive test results for drugs of abuse at screening;\n* Unable, or unwilling to tolerate multiple venipunctures;\n* Difficulty fasting or eating the standard meals that will be provided;\n* Use of tobacco or nicotine-containing products within 90 days of the study start to the Follow-up visit"}, 'identificationModule': {'nctId': 'NCT02174250', 'briefTitle': 'The Effect of Rifampin on the Metabolism of Istradefylline in Healthy Volunteers.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kyowa Kirin Co., Ltd.'}, 'officialTitle': 'Effect of a Strong Enzyme Inducer, Rifampin, on the Single-Dose Pharmacokinetics of Istradefylline in Healthy Subjects', 'orgStudyIdInfo': {'id': '6002-015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Istradefylline 40mg', 'description': 'Period 1: Day 1, istradefylline 40mg then crossover to Period 2', 'interventionNames': ['Drug: Istradefylline 40 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Rifampin 300mg BID + istradefylline 40mg', 'description': 'Period 2: Days 1-20 rifampin 300mg BID + istradefylline 40mg Day 8 only', 'interventionNames': ['Drug: Istradefylline 40 mg', 'Drug: Rifampin 300mg BID + istradefylline 40mg Day 8 only']}], 'interventions': [{'name': 'Istradefylline 40 mg', 'type': 'DRUG', 'otherNames': ['KW-6002'], 'description': 'On Day 1, istradefylline 1 × 40-mg tablet administered alone', 'armGroupLabels': ['Istradefylline 40mg', 'Rifampin 300mg BID + istradefylline 40mg']}, {'name': 'Rifampin 300mg BID + istradefylline 40mg Day 8 only', 'type': 'DRUG', 'otherNames': ['rifadin'], 'description': 'On Days 1 - 20, rifampin 300mg BID; On Day 8, istradefylline 40 mg administered first with rifampin about 2 hours after istradefylline administration', 'armGroupLabels': ['Rifampin 300mg BID + istradefylline 40mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85283', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Celerion, Inc.', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}], 'overallOfficials': [{'name': 'Marc Cantillon, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Kyowa Hakko Kirin Pharma, Inc.'}, {'name': 'Amy Zhang, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kyowa Hakko Kirin Pharma, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyowa Kirin Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Kyowa Hakko Kirin Pharma, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}