Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2026-02-25 @ 5:34 PM
Study NCT ID:
NCT00448032
Status:
COMPLETED
Last Update Posted:
2007-12-05
First Post:
2007-03-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Evaluating Multiple Oral Doses of PPM-204 in Healthy Japanese Male Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-12-03', 'studyFirstSubmitDate': '2007-03-14', 'studyFirstSubmitQcDate': '2007-03-14', 'lastUpdatePostDateStruct': {'date': '2007-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics/Pharmacodynamics'}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'A study evaluating the safety and pharmacokinetics of multiple oral doses of an investigational oral diabetic agent when given to healthy Japanese male volunteers.'}, '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\n* Body mass index in the range of 17.6 to 26.4 kg/m2\n* Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG)\n\nExclusion Criteria:\n\n* History of cardiac, thyroid, muscle, and kidney abnormalities\n* History of NSAID induced bronchospasm or asthma\n* History of any clinically important allergies'}, 'identificationModule': {'nctId': 'NCT00448032', 'briefTitle': 'Study Evaluating Multiple Oral Doses of PPM-204 in Healthy Japanese Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, 'officialTitle': 'A Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Ppm-204 Administered Orally to Healthy Male Japanese Subjects', 'orgStudyIdInfo': {'id': '3180A1-107'}}, 'armsInterventionsModule': {'interventions': [{'name': 'PPM-204', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '171-0014', 'city': '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'}}}}