Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-01-28 @ 6:50 PM
Study NCT ID:
NCT00862667
Status:
COMPLETED
Last Update Posted:
2009-06-24
First Post:
2009-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study To Estimate The Time Course Of PF-00241939 Concentration In The Blood Following Dosing By Oral Inhalation From Dry Powder Inhalers.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-06-23', 'studyFirstSubmitDate': '2009-02-19', 'studyFirstSubmitQcDate': '2009-03-16', 'lastUpdatePostDateStruct': {'date': '2009-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma pharmacokinetic parameters: AUClast & Cmax.', 'timeFrame': '48 hours'}], 'secondaryOutcomes': [{'measure': 'Plasma pharmacokinetic parameters: AUC0-12, AUC0-24, AUCinf, Tmax and t½.', 'timeFrame': '48 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pharmacokinetics'], 'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0871002&StudyName=A%20Study%20To%20Estimate%20The%20Time%20Course%20Of%20PF-00241939%20Concentration%20In%20The%20Blood%20Following%20Dosing%20By%20Oral%20Inhalation%20From%20Dry%20Powder%20In', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the time course of PF-00241939 concentration in the blood following dosing by oral inhalation from dry powder inhalers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male and/or female subjects between the ages of 21 and 55 years.\n* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \\>50 kg (110 lbs).\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* History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males.\n* Pregnant or nursing females.'}, 'identificationModule': {'nctId': 'NCT00862667', 'acronym': 'B0871002', 'briefTitle': 'A Study To Estimate The Time Course Of PF-00241939 Concentration In The Blood Following Dosing By Oral Inhalation From Dry Powder Inhalers.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'An Open Study To Estimate The Plasma Pharmacokinetics Of PF-00241939 Administered Via Oral Inhalation Using Dry Powder Inhalers.', 'orgStudyIdInfo': {'id': 'B0871002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment A', 'description': 'PF-00241939 300ug using Inhaler A', 'interventionNames': ['Drug: Treatment A']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment B', 'description': 'PF-00241939 300ug using Inhaler B', 'interventionNames': ['Drug: Treatment B']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment C', 'description': 'PF-00241939 300ug using Inhaler C', 'interventionNames': ['Drug: Treatment C']}], 'interventions': [{'name': 'Treatment A', 'type': 'DRUG', 'description': 'PF-00241939 300ug using Inhaler A', 'armGroupLabels': ['Treatment A']}, {'name': 'Treatment B', 'type': 'DRUG', 'description': 'PF-00241939 300ug using Inhaler B', 'armGroupLabels': ['Treatment B']}, {'name': 'Treatment C', 'type': 'DRUG', 'description': 'PF-00241939 300ug using Inhaler C', 'armGroupLabels': ['Treatment C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '188770', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], '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.'}}}}