Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-26 @ 3:26 AM
Study NCT ID:
NCT00750620
Status:
COMPLETED
Last Update Posted:
2013-09-05
First Post:
2008-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Pharmacokinetic Study of YM178 in Normal Subjects and Those With Mild, Moderate, and Severe Renal Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C520025', 'term': 'mirabegron'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-04', 'studyFirstSubmitDate': '2008-09-08', 'studyFirstSubmitQcDate': '2008-09-09', 'lastUpdatePostDateStruct': {'date': '2013-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of pharmacokinetics parameters', 'timeFrame': 'day 1 - day 6'}], 'secondaryOutcomes': [{'measure': 'Metabolite analysis', 'timeFrame': 'day 1 - day 6'}, {'measure': 'Assessment of safety and tolerability', 'timeFrame': 'day 1 - day 6'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['mild, moderate, and severe renal impaired subjects', 'normal renal function subjects', 'Glomerular filtration rate (GFR)', 'Modification of Diet in Renal Disease (MDRD) formula', 'YM178', 'pharmacokinetics'], 'conditions': ['Renal Impairment']}, 'referencesModule': {'references': [{'pmid': '23208320', 'type': 'BACKGROUND', 'citation': 'Dickinson J, Lewand M, Sawamoto T, Krauwinkel W, Schaddelee M, Keirns J, Kerbusch V, Moy S, Meijer J, Kowalski D, Morton R, Lasseter K, Riff D, Kupcova V, van Gelderen M. Effect of renal or hepatic impairment on the pharmacokinetics of mirabegron. Clin Drug Investig. 2013 Jan;33(1):11-23. doi: 10.1007/s40261-012-0031-3.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to assess and compare the pharmacokinetic properties of YM178 in normal subjects and those with mild, moderate and severe renal impairment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* good health other than renal impairment\n* body mass index (BMI) between 18 and 40 kg/m2\n\nExclusion Criteria:\n\n* subject with renal impairment has not been on stable dose of concomitant medication for at least 2 weeks\n* subject has liver enzyme abnormalities'}, 'identificationModule': {'nctId': 'NCT00750620', 'briefTitle': 'A Pharmacokinetic Study of YM178 in Normal Subjects and Those With Mild, Moderate, and Severe Renal Impairment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'A Phase 1, Open-Label, Single-Dose, Parallel-Group Study to Assess the Effect of Mild, Moderate and Severe Renal Impairment on the Pharmacokinetics of YM178', 'orgStudyIdInfo': {'id': '178-CL-038'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1. Severe renal impairment', 'description': 'severe renal impairment', 'interventionNames': ['Drug: YM178']}, {'type': 'EXPERIMENTAL', 'label': '2. Moderate renal impairment', 'description': 'moderate renal impairment', 'interventionNames': ['Drug: YM178']}, {'type': 'EXPERIMENTAL', 'label': '3. Mild renal impairment', 'description': 'mild renal impairment', 'interventionNames': ['Drug: YM178']}, {'type': 'EXPERIMENTAL', 'label': '4. Normal renal function', 'description': 'normal renal function', 'interventionNames': ['Drug: YM178']}], 'interventions': [{'name': 'YM178', 'type': 'DRUG', 'otherNames': ['mirabegron'], 'description': 'oral', 'armGroupLabels': ['1. Severe renal impairment', '2. Moderate renal impairment', '3. Mild renal impairment', '4. Normal renal function']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '33014-3616', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Central Contact', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Astellas Pharma Global Development'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}