Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:44 AM
Study NCT ID:
NCT01415102
Status:
COMPLETED
Last Update Posted:
2011-08-15
First Post:
2010-09-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A First In Human Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Single Inhaled Doses Of PF-05212372.
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': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-12', 'studyFirstSubmitDate': '2010-09-29', 'studyFirstSubmitQcDate': '2011-08-10', 'lastUpdatePostDateStruct': {'date': '2011-08-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Adverse Events as a Measure of Safety and Tolerability', 'timeFrame': '14 days'}, {'measure': 'Plasma pharmacokinetics', 'timeFrame': 'up to 72 hours post dose'}, {'measure': 'Urine pharmacokinetics', 'timeFrame': 'up to 24 hours post dose'}, {'measure': 'Urine Pharmacodynamics', 'timeFrame': 'up to 24 hours post dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Phase 1', 'Single Dose', 'Safety', 'Toleration', 'Pharmacokinetics']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B2031001&StudyName=A%20First%20In%20Human%20Study%20In%20Healthy%20People%20To%20Evaluate%20Safety%2C%20Toleration%20And%20Time%20Course%20Of%20Plasma%20Concentration%20Of%20Single%20Inhaled%20', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study in healthy people is to evaluate safety, toleration and time course of plasma concentration of single inhaled doses of PF-05212372.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHealthy subjects. (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\nExclusion Criteria:\n\n* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).\n* A positive urine drug screen.\n* Treatment with an investigational drug within the past 30 days (or local regulations) or 5 half-lives preceding the first dose of study medication.'}, 'identificationModule': {'nctId': 'NCT01415102', 'briefTitle': 'A First In Human Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Single Inhaled Doses Of PF-05212372.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Double Blind (3rd Party Open), Randomised, Placebo-Controlled, Dose Escalation Study To Investigate The Safety, Toleration, And Pharmacokinetics Of Single Inhaled Doses Of Pf-05212372 In Healthy Subjects', 'orgStudyIdInfo': {'id': 'B2031001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': 'Subjects will be assigned to receive either PF-05212372 or placebo in each period', 'interventionNames': ['Drug: PF-05212372', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': 'Subjects will be assigned to receive either PF-05212372 or placebo in each period', 'interventionNames': ['Drug: PF-05212372', 'Drug: Placebo']}], 'interventions': [{'name': 'PF-05212372', 'type': 'DRUG', 'description': 'Inhaled. Dose Level 1: 50 ug', 'armGroupLabels': ['Cohort 1']}, {'name': 'PF-05212372', 'type': 'DRUG', 'description': 'Inhaled. Dose Level 2 - Dose to be selected based upon safety/tolerability/PK at preceding dose', 'armGroupLabels': ['Cohort 1']}, {'name': 'PF-05212372', 'type': 'DRUG', 'description': 'Inhaled. Dose Level 3 - Dose to be selected based upon safety/tolerability/PK at preceding dose', 'armGroupLabels': ['Cohort 1']}, {'name': 'PF-05212372', 'type': 'DRUG', 'description': 'Inhaled. Dose Level 4 - Dose to be selected based upon safety/tolerability/PK at preceding dose', 'armGroupLabels': ['Cohort 1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Inhaled', 'armGroupLabels': ['Cohort 1']}, {'name': 'PF-05212372', 'type': 'DRUG', 'description': 'Inhaled. Dose Level 5 - Dose to be selected based upon safety/tolerability/PK at preceding dose', 'armGroupLabels': ['Cohort 2']}, {'name': 'PF-05212372', 'type': 'DRUG', 'description': 'Inhaled. Dose Level 6 - Dose to be selected based upon safety/tolerability/PK at preceding dose', 'armGroupLabels': ['Cohort 2']}, {'name': 'PF-05212372', 'type': 'DRUG', 'description': 'Inhaled. Dose Level 7 - Dose to be selected based upon safety/tolerability/PK at preceding dose', 'armGroupLabels': ['Cohort 2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Inhaled', 'armGroupLabels': ['Cohort 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B-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': {'oldNameTitle': 'Director, Clinical Trial Disclosure Group', 'oldOrganization': 'Pfizer, Inc.'}}}}