Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2026-01-21 @ 10:43 AM
Study NCT ID:
NCT01373060
Status:
COMPLETED
Last Update Posted:
2011-10-12
First Post:
2011-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of ASP1941 in Healthy Male Taiwanese Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006029', 'term': 'Glycosuria'}], 'ancestors': [{'id': 'D014555', 'term': 'Urination Disorders'}, {'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': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C572941', 'term': 'ipragliflozin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-10', 'studyFirstSubmitDate': '2011-05-31', 'studyFirstSubmitQcDate': '2011-06-13', 'lastUpdatePostDateStruct': {'date': '2011-10-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety assessed by the incidence of adverse events, vital signs, safety lab tests and 12-lead ECG', 'timeFrame': 'up to 72 hours'}], 'secondaryOutcomes': [{'measure': 'Cmax of ASP1941 plasma concentration', 'timeFrame': 'up to 72 hours'}, {'measure': 'AUC (Area under the curve) of ASP1941 plasma concentration', 'timeFrame': 'up to 72 hours'}, {'measure': 'Changes in plasma glucose', 'timeFrame': 'baseline and up to 72 hours'}, {'measure': 'Changes in urine glucose', 'timeFrame': 'baseline and up to 72 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ASP1941', 'ipragliflozin', 'plasma glucose', 'urine glucose'], 'conditions': ['Healthy', 'Pharmacokinetics of ASP1941']}, 'descriptionModule': {'briefSummary': 'This study assesses the safety, tolerability, pharmacokinetics and pharmacodynamics of ASP1941 orally administered as single doses to healthy adult male Taiwanese subjects.', 'detailedDescription': 'The subjects will be administered a single dose of ASP1941 or placebo under fasting condition. Plasma and urine levels of ASP1941 and glucose will be measured to investigate pharmacokinetic and pharmacodynamic properties of ASP1941.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body weight between 50 and 85 kg, and Body Mass Index (BMI) between 17.6 and 26.4 kg/m2 inclusive\n\nExclusion Criteria:\n\n* Medical history of metabolic disease, hepatic disease, heart disorder, respiratory disease, gastrointestinal disease, renal disease, cerebrovascular disorder, malignant tumor, drug allergy and drug/alcohol dependence\n* Blood pressure, pulse rate, body temperature and 12-lead ECG are outside of the preset normal range\n* Labo test results deviate from preset normal range\n* Receiving treatment, including medication, within 14 days before the study\n* Receiving medication in another clinical study or a post-marketing clinical trial within 3 months before the study\n* Donates 500mL of whole blood within 3 months or 250mL within 2 months or blood components within 14 days before the study\n* Drinking more than 45g of alcohol, or smoking more than 20 cigarettes per day\n* Employed by the sponsor, delegated CRO or the study site\n* Fasting plasma glucose level of \\< 70 mg/dL or ≥110 mg/dL or with an HbA1c ≥5.8%\n* Subjects with positive serology test for Hepatitis B antigen, Hepatitis A virus IgM, anti-Hepatitis C virus or anti-Human Immunodeficiency virus-1 or -2'}, 'identificationModule': {'nctId': 'NCT01373060', 'briefTitle': 'A Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of ASP1941 in Healthy Male Taiwanese Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'A Double-blind, Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Oral Doses of ASP1941 in Healthy Male Taiwanese Subjects', 'orgStudyIdInfo': {'id': '1941-CL-2001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ASP1941 group', 'interventionNames': ['Drug: ASP1941']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo group', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ASP1941', 'type': 'DRUG', 'otherNames': ['ipragliflozin'], 'description': 'oral', 'armGroupLabels': ['ASP1941 group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'oral', 'armGroupLabels': ['placebo 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'}}}}