Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2026-01-28 @ 6:23 PM
Study NCT ID:
NCT02537002
Status:
COMPLETED
Last Update Posted:
2016-04-29
First Post:
2015-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Dose Study of PF-05230907 in Healthy Japanese Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000717013', 'term': 'PF-05230907'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-28', 'studyFirstSubmitDate': '2015-08-28', 'studyFirstSubmitQcDate': '2015-08-28', 'lastUpdatePostDateStruct': {'date': '2016-04-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Adverse Events and Serious Adverse Events Per Participant of PF-05230907', 'timeFrame': 'up to 2 months'}], 'secondaryOutcomes': [{'measure': 'Single dose Time to Reach maximum Observed Plasma Concentration (Tmax) of PF-05230907', 'timeFrame': 'Minute 0, 2, 5, 15, 40, 60 minute post-dose'}, {'measure': 'Single dose Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]of PF-05230907', 'timeFrame': 'Minute 0, 2, 5, 15, 40, 60 minute post-dose'}, {'measure': 'Single dose Plasma Decay Half-Life (t1/2) of PF-05230907', 'timeFrame': 'Minute 0, 2, 5, 15, 40, 60 minute post-dose'}, {'measure': 'Single dose steady state Volume of Distribution (Vss) of PF-05230907', 'timeFrame': 'Minute 0, 2, 5, 15, 40, 60 minute post-dose'}, {'measure': 'Single dose clearance (CL) of PF-05230907', 'timeFrame': 'Minute 0, 2, 5, 15, 40, 60 minute post-dose'}, {'measure': 'Single dose Maximum Observed plasma concentration (Cmax) of PF-05230907', 'timeFrame': 'Minute 0, 2, 5, 15, 40, 60 minute post-dose'}, {'measure': 'Single dose Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (last)]of PF-05230907', 'timeFrame': 'Minute 0, 2, 5, 15, 40, 60 minute post-dose'}, {'measure': 'Change of aPTT from pre-dose to post-dose', 'timeFrame': 'Hour 0, 24 hour post-dose'}, {'measure': 'Change of prothrombin fragments 1+2 (PF1+2)', 'timeFrame': 'Hour 0, 24 hour post-dose'}, {'measure': 'Change of plasma D-dimer', 'timeFrame': 'Hour 0, 48 hour post-dose'}, {'measure': 'Incidence of development of anti-drug antibody (ADA)', 'timeFrame': 'up to 2 months'}, {'measure': 'Incidence of development of neutralizing antibody (NAb)', 'timeFrame': 'up to 2 months'}, {'measure': 'Change of factor X activity', 'timeFrame': 'up to 2 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PF-05230907', 'Pharmacokinetics', 'Pharmacodynamic', 'Immunogenicity'], 'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B2341003&StudyName=A%20Phase%201%2C%20Randomized%2C%20Double-blind%2C%20Sponsor-open%2C%20Placebo-controlled%2C%20Single%20Ascending%20Dose%20Study%20To%20Evaluate%20The%20Safety%2C%20Tolerability%2C%20Pharmacokinetics%20And%20Pharmacodynamics%20Of%20An%20Intravenous%20Bolus%20Infusion%20Pf-05230907%20In%20Healthy%20Japanese%20Subjects', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is the following:\n\n* To determine the safety and tolerability of single ascending intravenous (IV) doses of PF-05230907 in healthy Japanese subjects.\n* To characterize the PK profile of single ascending IV doses of PF-05230907 in healthy Japanese subjects.\n* To characterize the PD profiles of single ascending IV doses of PF-05230907 in healthy Japanese subjects.\n* To evaluate the immunogenicity of PF-05230907 in healthy Japanese subjects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male of females\n* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \\>50 kg (110 lbs) and \\<120 kg (265 lbs).\n* Japanese subjects who have four biologic Japanese grandparents born in Japan.\n\nExclusion Criteria:\n\n* Pregnant or nursing females.\n* Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception.\n* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease'}, 'identificationModule': {'nctId': 'NCT02537002', 'briefTitle': 'Single Dose Study of PF-05230907 in Healthy Japanese Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 1, Randomized, Double-blind, Sponsor-open, Placebo-controlled, Single Ascending Dose Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of An Intravenous Bolus Infusion Pf-05230907 In Healthy Japanese Subjects', 'orgStudyIdInfo': {'id': 'B2341003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1- PF-05230907 or Placebo', 'interventionNames': ['Drug: PF-05230907', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2- PF-05230907 or Placebo', 'interventionNames': ['Drug: PF-05230907', 'Drug: Placebo']}], 'interventions': [{'name': 'PF-05230907', 'type': 'DRUG', 'description': 'A single intravenous dose of 3 μg/kg', 'armGroupLabels': ['Cohort 1- PF-05230907 or Placebo']}, {'name': 'PF-05230907', 'type': 'DRUG', 'description': 'A single intravenous dose of 5 μg/kg', 'armGroupLabels': ['Cohort 2- PF-05230907 or Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'A single intravenous dose of matched placebo', 'armGroupLabels': ['Cohort 1- PF-05230907 or Placebo', 'Cohort 2- PF-05230907 or Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06511-5473', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Pfizer New Haven Clinical Research Unit', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}