Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-01-05 @ 3:38 AM
Study NCT ID:
NCT00480467
Status:
COMPLETED
Last Update Posted:
2007-12-05
First Post:
2007-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAM-315 in Healthy Japanese Males
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C554418', 'term': '3-(naphthalen-1-ylsulfonyl)-5-(piperazin-1-yl)-1H-indazole'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-12-03', 'studyFirstSubmitDate': '2007-05-29', 'studyFirstSubmitQcDate': '2007-05-29', 'lastUpdatePostDateStruct': {'date': '2007-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics and pharmacodynamics'}]}, 'conditionsModule': {'conditions': ['Alzheimer Disease']}, 'descriptionModule': {'briefSummary': 'To assess the safety and tolerability of ascending single oral doses of SAM-315, an investigational drug, in healthy Japanese male subjects.To obtain preliminary pharmacokinetic (PK) and pharmacodynamic (PD) profiles of SAM-315 in healthy Japanese male subjects.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Men aged 20 to 45 years (inclusive) at the time of getting informed consent.\n* Body mass index (BMI) in the range of 18.5 to 25.0 kg/m2 and body weight≥50 kg (BMI = \\[weight (kg)\\]/\\[height (m)\\]2).\n* Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and digital 12-lead electrocardiogram (ECG). Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and creatinine levels must be within the upper limit of normal for eligibility.\n\nExclusion criteria\n\n* Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.\n* Any clinically important deviation from normal limits in physical examination, vital signs, digital 12-lead ECGs, or clinical laboratory test results.\n* Consumption of any caffeine-containing products (eg, coffee, tea, chocolate, or cola) or alcoholic beverages is prohibited from 48 hours and consumption of grapefruit or a grapefruit-containing products is prohibited from 72 hours before study day 1.'}, 'identificationModule': {'nctId': 'NCT00480467', 'briefTitle': 'Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAM-315 in Healthy Japanese Males', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, 'officialTitle': 'Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of SAM-315 Administered Orally to Healthy Japanese Male Subjects', 'orgStudyIdInfo': {'id': '3182A1-102'}}, 'armsInterventionsModule': {'interventions': [{'name': 'SAM-315', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '305-0856', 'city': 'Ibaraki Pref', 'country': 'Japan'}], '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'}}}}