Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-25 @ 8:58 PM
Study NCT ID:
NCT00509756
Status:
TERMINATED
Last Update Posted:
2010-10-22
First Post:
2007-07-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study Evaluating FXR-450 in Healthy Japanese Men
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C540004', 'term': 'WAY-362450'}]}}, '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': {'whyStopped': 'Please see termination statement in the detailed description.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-10-21', 'studyFirstSubmitDate': '2007-07-30', 'studyFirstSubmitQcDate': '2007-07-30', 'lastUpdatePostDateStruct': {'date': '2010-10-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome is safety and tolerability.', 'timeFrame': '4 days'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics', 'timeFrame': '4 days'}]}, 'conditionsModule': {'keywords': ['healthy subjects'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of a single dose of FXR-450 in healthy Japanese men.', 'detailedDescription': 'This study was terminated on May 2008. The reason for termination was due to pharmacokinetics issues. The decision to terminate was not due to safety and tolerability.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men aged 20 to 45 years.\n* Healthy as determined by the investigator.\n* Nonsmoker or smoker of fewer than 10 cigarettes per day.\n\nExclusion Criteria:\n\n* A history or active presence of clinically important medical disease.\n* Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the test article (e.g., resection of liver, kidney, gallbladder, or gastrointestinal tract).'}, 'identificationModule': {'nctId': 'NCT00509756', 'briefTitle': 'Study Evaluating FXR-450 in Healthy Japanese Men', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, 'officialTitle': 'Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of FXR-450 Administered Orally to Healthy Japanese Male Subjects', 'orgStudyIdInfo': {'id': '3213A1-1002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Drug: FXR-450', 'interventionNames': ['Drug: FXR-450']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'FXR-450', 'type': 'DRUG', 'description': 'capsule, single oral doses from 10 mg to 450 mg', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'capsule similar to active drug', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '171-0014', 'city': 'Tokyo', 'state': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Wyeth is now a wholly owned subsidiary of Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wyeth is now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Wyeth (Registry Contact: Clinical Trial Registry Specialist)', 'oldOrganization': 'Wyeth'}}}}