Ignite Creation Date:
2025-12-25 @ 12:07 AM
Ignite Modification Date:
2025-12-25 @ 10:06 PM
Study NCT ID:
NCT00719758
Status:
COMPLETED
Last Update Posted:
2008-10-13
First Post:
2008-07-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Drug-Drug Interaction Study of TRK-100STP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C048081', 'term': 'beraprost'}, {'id': 'C040896', 'term': 'AST 120'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-10', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-10-09', 'studyFirstSubmitDate': '2008-07-18', 'studyFirstSubmitQcDate': '2008-07-21', 'lastUpdatePostDateStruct': {'date': '2008-10-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic profile', 'timeFrame': '1 day'}], 'secondaryOutcomes': [{'measure': 'Safety parameters (vital signs, ECG, laboratory tests)', 'timeFrame': '1 day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['TRK-100STP,', 'beraprost sodium,', 'Careload LA', 'AST-120', 'Spherical carbon adsorbent', 'Drug-drug interaction'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of AST-120 on the PK of TRK-100STP, and to evaluate the safety and tolerability of TRK-100STP alone or in combination with AST-120', 'detailedDescription': 'Non-blinded, randomized and crossover study to evaluate pharmacokinetic interaction between TRK-100STP and AST-120 in different administration condition. Nonelderly adult volunteers will receive TRK-100STP with or without AS-T120 after meal. Safety parameters will concurrently be measured.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of written informed consent\n* Body Mass Index (BMI) of ≥17.6 to ≤26.4 kg/m2 and weight of ≥50 to ≤80 kg\n\nExclusion Criteria:\n\n* Clinical abnormal physical findings, including BP, pulse rate, ECG and laboratory assessments\n* Receives any investigational medicine within 120 days before screening\n* Recent blood donor'}, 'identificationModule': {'nctId': 'NCT00719758', 'briefTitle': 'Drug-Drug Interaction Study of TRK-100STP', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'TRK-100STP Pharmacokinetic Study in Healthy Volunteers - Evaluation of Pharmacokinetic Interaction Between TRK-100STP and Kremezin', 'orgStudyIdInfo': {'id': '533-CL-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Cross-over study', 'interventionNames': ['Drug: TRK-100STP (BERASUS LA)', 'Drug: AST-120 (Kremezin®)']}], 'interventions': [{'name': 'TRK-100STP (BERASUS LA)', 'type': 'DRUG', 'otherNames': ['beraprost', 'Careload LA', 'BERASUS LA'], 'description': 'oral', 'armGroupLabels': ['1']}, {'name': 'AST-120 (Kremezin®)', 'type': 'DRUG', 'otherNames': ['Kremezin®', 'sopherical carbon adsorbent'], 'description': 'oral', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '108-8642', 'city': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Central Contact', 'role': 'STUDY_CHAIR', 'affiliation': 'Astellas Pharma Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Toray Industries, Inc', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Director', 'oldOrganization': 'Astellas Pharma Inc.'}}}}