Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:04 AM
Study NCT ID:
NCT01334905
Status:
COMPLETED
Last Update Posted:
2013-06-12
First Post:
2011-04-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Safety and Effect of Food on the Pharmacokinetics of YM178 in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}, {'id': 'D014549', 'term': 'Urinary Incontinence'}], 'ancestors': [{'id': 'D001745', 'term': 'Urinary Bladder 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': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014555', 'term': 'Urination Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C520025', 'term': 'mirabegron'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-10', 'studyFirstSubmitDate': '2011-04-12', 'studyFirstSubmitQcDate': '2011-04-12', 'lastUpdatePostDateStruct': {'date': '2013-06-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum plasma concentration (Cmax) of YM178', 'timeFrame': 'Up to 96 hrs post dose'}, {'measure': 'AUC (area under the curve) of YM178 plasma concentration', 'timeFrame': 'Up to 96 hrs post dose'}], 'secondaryOutcomes': [{'measure': 'tmax of YM178 plasma concentration', 'timeFrame': 'Up to 96 hrs post dose'}, {'measure': 't1/2 of YM178 plasma concentration', 'timeFrame': 'Up to 96 hrs post dose'}, {'measure': 'Safety assessed by the incidence of adverse events, clinical lab tests, vital signs, 12-lead ECGs and physical exam.', 'timeFrame': 'Up to 96 hrs post dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Overactive Bladder', 'Urinary incontinence', 'YM178', 'mirabegron', 'Food effect'], 'conditions': ['Healthy Volunteer', 'Pharmacokinetics of YM178']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate safety of YM178 and the effect of food intake on the pharmacokinetics of YM178 in healthy adult subjects.', 'detailedDescription': 'A open-label, randomized, crossover study to assess the effect of food on the pharmacokinetics of single dose of YM178 administered under fasted and fed conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A normal or clinically non-significant 12 lead ECG as well as normal or clinically non-significant laboratory test results at the time of Screening\n* Body weigh at least 50 kg in male and 45 kg in female and body mass index (BMI) between 18.5 and 26.9 kg/m2\n* All women of child bearing potential are required to use adequate contraception consisting of two forms of birth control\n\nExclusion Criteria:\n\n* Hypersensitivity to YM178 or other beta-3 agonists or any of the constituents of the formulation used\n* Liver function test values above the upper limit of normal\n* A history or presence of psychiatric illness, serious active or recurrent infection\n* A previous history of cancer other than basal cell carcinoma or Stage 1 squamous cell carcinoma that has not been in remission for at least 5 years prior to the study\n* Donated or lost ≥ 500 mL blood within 3 months or donated plasma within 2 weeks prior to the study\n* Receiving or being anticipated to receive a prescription drug or OTC medications within 14 days prior to the study\n* Consuming alcohol, xanthine derivative-containing food/beverages (tea, chocolate), grapefruit juice, grapefruit-containing products or Seville oranges (e.g., bitter marmalade) within 48 hours before the study\n* A history of substance abuse, drug addiction, or alcoholism within past 2 years prior to the study\n* currently participating in another clinical trial or taking or has been taking an investigational drug at least 60 days'}, 'identificationModule': {'nctId': 'NCT01334905', 'briefTitle': 'A Study to Investigate the Safety and Effect of Food on the Pharmacokinetics of YM178 in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'A Phase 1, Open-Label, Single Oral Dose Study to Assess the Safety, Pharmacokinetics and Effect of Food on the Pharmacokinetics of Mirabegron (YM178) in Healthy Volunteers', 'orgStudyIdInfo': {'id': '178-CL-092'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A group', 'description': 'fasted condition then fed condition', 'interventionNames': ['Drug: YM178']}, {'type': 'EXPERIMENTAL', 'label': 'Part B group', 'description': 'fed condition then fasted condition', 'interventionNames': ['Drug: YM178']}], 'interventions': [{'name': 'YM178', 'type': 'DRUG', 'otherNames': ['mirabegron'], 'description': 'oral', 'armGroupLabels': ['Part A group', 'Part B group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'country': 'Taiwan', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Use Central Contact', 'role': 'STUDY_CHAIR', 'affiliation': 'Astellas Pharma Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Astellas Pharma Taiwan, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}