Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-01-01 @ 9:38 PM
Study NCT ID:
NCT00452504
Status:
COMPLETED
Last Update Posted:
2007-12-05
First Post:
2007-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Ascending Dose Study of SRA-444 in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-12-03', 'studyFirstSubmitDate': '2007-03-23', 'studyFirstSubmitQcDate': '2007-03-23', 'lastUpdatePostDateStruct': {'date': '2007-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of the safety and tolerability of SRA-444'}]}, 'conditionsModule': {'conditions': ['Alzheimer Disease']}, 'descriptionModule': {'briefSummary': 'This is a first-in-humans study of SRA-444. This study will provide an initial assessment of the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of SRA-444 (SR formulation) after administration of ascending single oral doses to healthy adult subjects.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Healthy men or women of nonchildbearing potential aged 18 to 50 years,\n* Body mass index in the range of 18 to 30 kg/m2 and body weight ≥50 kg.\n\nExclusion criteria:\n\n* Family history of sudden death and/or QT prolongation.\n* An automatic ECG corrected QT (QTc) interval reading at screening \\>450 ms and \\>470 ms for male and female subjects, respectively.\n* Sinus bradycardia at screening, defined as a resting heart rate ≤45 bpm. Resting supine blood pressure at screening \\<110 mm Hg (systolic) and/or \\<60 mm Hg (diastolic).'}, 'identificationModule': {'nctId': 'NCT00452504', 'briefTitle': 'Single Ascending Dose Study of SRA-444 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, 'officialTitle': 'Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SRA-444 Administered Orally to Healthy Adult Subjects', 'orgStudyIdInfo': {'id': '3197A1-100'}}, 'armsInterventionsModule': {'interventions': [{'name': 'SRA-444', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '9470 AE', 'city': 'Zuidlaren', 'country': 'Netherlands', 'geoPoint': {'lat': 53.09417, 'lon': 6.68194}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, {'name': 'Trial Manager', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'For Netherlands, trials-NL@wyeth.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wyeth is now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}}}}