Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-26 @ 12:44 AM
Study NCT ID:
NCT00379860
Status:
TERMINATED
Last Update Posted:
2007-03-09
First Post:
2006-09-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study Evaluation LXR-623 in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C547927', 'term': '2-(2-chloro-4-fluorobenzyl)-3-(4-fluorophenyl)-7-(trifluoromethyl)-2H-indazole'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-10'}, 'statusVerifiedDate': '2007-03', 'completionDateStruct': {'date': '2007-01'}, 'lastUpdateSubmitDate': '2007-03-08', 'studyFirstSubmitDate': '2006-09-21', 'studyFirstSubmitQcDate': '2006-09-21', 'lastUpdatePostDateStruct': {'date': '2007-03-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety is the primary outcome.'}]}, 'conditionsModule': {'conditions': ['Healthy Subjects']}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and tolerability of multiple doses of LXR in healthy adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Generally healthy adults.\n* Liver function tests, triglycerideres, and creatinine must be below upper limit of normal at screening.\n\nExclusion Criteria:\n\n* A history or active presence of clinically important medical disease.\n* Any metal implants or devices.\n* Claustrophobia.'}, 'identificationModule': {'nctId': 'NCT00379860', 'briefTitle': 'Study Evaluation LXR-623 in Healthy Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, 'officialTitle': 'A Multiple Ascending Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of LXR-623 Administered Orally to Healthy Subjects', 'orgStudyIdInfo': {'id': '3201A1-101'}}, 'armsInterventionsModule': {'interventions': [{'name': 'LXR-623', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'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'}}}}