Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2026-01-19 @ 4:28 PM
Study NCT ID:
NCT00981968
Status:
COMPLETED
Last Update Posted:
2010-10-15
First Post:
2009-09-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1, Single and Multiple Doses Study of Sitaxentan in Japanese and Western Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-10-14', 'studyFirstSubmitDate': '2009-09-21', 'studyFirstSubmitQcDate': '2009-09-21', 'lastUpdatePostDateStruct': {'date': '2010-10-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events (spontaneous and solicited)', 'timeFrame': 'Day 0 to Day 9 of Period 3 for cohort 1, Day 0 to Day 3 of Period 2 for cohort 2'}, {'measure': 'ECGs, Vital signs, Safety laboratory test', 'timeFrame': 'Screening visit to Day 9 of Period 3 for cohort 1 and Day 3 of Period 2 for cohort 2'}, {'measure': 'Pharmacokinetics (single dose): Cmax, Tmax, AUC, t1/2, CL/F and V/F', 'timeFrame': 'Day 1 of Periods 1 and 2'}, {'measure': 'Pharmacokinetics (multiple dose): Cmax, Tmax, Ctrough, AUC, t1/2, CL/F, V/F, Rac and Rss', 'timeFrame': 'Days 1 and 7 of Periods 1 and 3'}], 'secondaryOutcomes': [{'measure': 'No secondary outcome', 'timeFrame': 'No secondary outcome'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1321046&StudyName=Phase%201%2C%20single%20and%20multiple%20doses%20study%20of%20sitaxentan%20in%20Japanese%20and%20Western%20subjects', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate safety, tolerability and pharmacokinetics of sitaxentan following single and multiple oral administrations of sitaxentan sodium in Japanese healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHealthy male and/or female subjects between the age of 18 and 55 years, inclusive.\n\nBody Mass Index of 17.5 to 33.5 kg/m2, and a total body weight \\>45 kg. Mean body weight and the body weight range of Western subjects are similar to those of Japanese subjects with a 10% plus and minus error.\n\nExclusion Criteria:\n\nPregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception.'}, 'identificationModule': {'nctId': 'NCT00981968', 'briefTitle': 'Phase 1, Single and Multiple Doses Study of Sitaxentan in Japanese and Western Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'An Investigator- And Subjects- Blind Phase 1 Study To Investigate Pharmacokinetics, Safety And Tolerability Of Sitaxentan In Japanese Healthy Subjects Following Single And Multiple Doses And Western Healthy Subjects Following Single Dose', 'orgStudyIdInfo': {'id': 'B1321046'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Japanese Cohort', 'description': 'Single and multiple oral doses of sitaxentan sodium or placebo in 12 healthy subjects.', 'interventionNames': ['Drug: Sitaxentan sodium/Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Western Cohort', 'description': 'Single oral dose of sitaxentan sodium in 10 healthy subjects.', 'interventionNames': ['Drug: Sitaxentan sodium/Placebo']}], 'interventions': [{'name': 'Sitaxentan sodium/Placebo', 'type': 'DRUG', 'otherNames': ['Thelin'], 'description': '100 mg and 200 mg, tablet, single and multiple oral doses for 7 days', 'armGroupLabels': ['Japanese Cohort']}, {'name': 'Sitaxentan sodium/Placebo', 'type': 'DRUG', 'otherNames': ['Thelin'], 'description': '100 mg and 200 mg, tablet, single oral dose', 'armGroupLabels': ['Western Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91206', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Director, Clinical Trial Disclosure Group', 'oldOrganization': 'Pfizer, Inc.'}}}}