Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2026-03-10 @ 11:38 PM
Study NCT ID:
NCT01117233
Status:
COMPLETED
Last Update Posted:
2012-01-18
First Post:
2010-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study In Healthy Adult Volunteers To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04427429
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']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-17', 'studyFirstSubmitDate': '2010-05-03', 'studyFirstSubmitQcDate': '2010-05-03', 'lastUpdatePostDateStruct': {'date': '2012-01-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events, Vitals, ECG, laboratory safety tests, IV infusion site reaction', 'timeFrame': 'up to 84 days'}, {'measure': 'Plasma pharmacokinetics of PF-04427429', 'timeFrame': 'up to 84 days'}], 'secondaryOutcomes': [{'measure': 'Free and total CGRP plasma concentrations', 'timeFrame': 'up to 84 days'}, {'measure': 'anti-drug antibody', 'timeFrame': 'up to 84 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Healthy volunteers', 'PK', 'PD', 'safety and toleration'], 'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0141002&StudyName=Study%20In%20Healthy%20Adult%20Volunteers%20To%20Evaluate%20The%20Safety%2C%20Tolerability%2C%20Pharmacokinetics%20And%20Pharmacodynamics%20Of%20PF-04427429', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose is to study the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-04427429 administered intravenously to healthy adult volunteers'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy male subjects between the ages of 18 and 50 years inclusive (unless local regulations dictate a minimum age of 21 years). Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests.\n* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight of between 50 kg and 100 kg inclusive.\n* Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial.\n\nExclusion Criteria:\n\n* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, genitourinary, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, symptomatic, seasonal allergies at time of dosing).\n* Any condition possibly affecting drug absorption.\n* 12-lead ECG demonstrating QTcF \\>450 msec at Screening. If QTcF exceeds 450 msec, the ECG should be repeated two more times and the average of the three QTcF values should be used to determine the subject's eligibility."}, 'identificationModule': {'nctId': 'NCT01117233', 'briefTitle': 'Study In Healthy Adult Volunteers To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04427429', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Randomised, Placebo Controlled, Double-Blind, Third Party Open, Parallel Group Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04427429 Administered Intravenously To Healthy Adult Volunteers', 'orgStudyIdInfo': {'id': 'B0141002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single IV Dose 1', 'interventionNames': ['Drug: PF-04427429']}, {'type': 'EXPERIMENTAL', 'label': 'Single IV Dose 2', 'interventionNames': ['Drug: PF-04427429']}, {'type': 'EXPERIMENTAL', 'label': 'Single IV Dose 3', 'interventionNames': ['Drug: PF-04427429']}, {'type': 'EXPERIMENTAL', 'label': 'Single IV Dose 4', 'interventionNames': ['Drug: PF-04427429']}, {'type': 'EXPERIMENTAL', 'label': 'Single IV Dose 5', 'interventionNames': ['Drug: PF-04427429']}], 'interventions': [{'name': 'PF-04427429', 'type': 'DRUG', 'description': 'single intravenous infusion of 10 mg PF-04427429 or placebo', 'armGroupLabels': ['Single IV Dose 1']}, {'name': 'PF-04427429', 'type': 'DRUG', 'description': 'single intravenous infusion of 30 mg PF-04427429 or placebo', 'armGroupLabels': ['Single IV Dose 2']}, {'name': 'PF-04427429', 'type': 'DRUG', 'description': 'single intravenous infusion of 100 mg PF-04427429 or placebo', 'armGroupLabels': ['Single IV Dose 3']}, {'name': 'PF-04427429', 'type': 'DRUG', 'description': 'single intravenous infusion of 300 mg PF-04427429 or placebo', 'armGroupLabels': ['Single IV Dose 4']}, {'name': 'PF-04427429', 'type': 'DRUG', 'description': 'single intravenous infusion of 1000 mg PF-04427429 or placebo', 'armGroupLabels': ['Single IV Dose 5']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}