Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-01-04 @ 5:33 PM
Study NCT ID:
NCT00990756
Status:
COMPLETED
Last Update Posted:
2010-01-22
First Post:
2009-10-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1 Study To Evaluate The Safety And Tolerability Of Different Doses Of PF-03526299 In Healthy Adult Volunteers
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': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-01-21', 'studyFirstSubmitDate': '2009-10-05', 'studyFirstSubmitQcDate': '2009-10-05', 'lastUpdatePostDateStruct': {'date': '2010-01-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety/toleration: Adverse events, vital signs, 12 lead ECG, blood and urine safety tests and physical examination.', 'timeFrame': '17 days'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic parameters: Plasma Day 1: Cmax, Tmax, AUCτau.', 'timeFrame': 'Day 1 - 17'}, {'measure': 'Plasma Day 7: Cmax, Tmax.', 'timeFrame': '7 Days'}, {'measure': 'Plasma Day 14: Cmax, Tmax, CL/F, AUCτau, t½, accumulation ratio, time to steady state.', 'timeFrame': '14 Days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9291003&StudyName=A%20Phase%201%20Study%20To%20Evaluate%20The%20Safety%20And%20Tolerability%20Of%20Different%20Doses%20Of%20PF-03526299%20In%20Healthy%20Adult%20Volunteers', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate safety and toleration of multiple inhaled doses as well as the time course of PF-03526299 concentration in the blood following dosing by dry powder inhaler.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male subjects and females of non-childbearing potential between the ages of 21 and 55 years.\n* Body Mass Index (BMI) of 17.5 to 30.5 kg/m\\^2; and a total body weight \\>50 kg (110 lbs).\n* Subjects who had a normal chest X-ray in the previous 6 months prior to Screening\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 21 drinks/week for males and 14 drinks/week for females.'}, 'identificationModule': {'nctId': 'NCT00990756', 'briefTitle': 'A Phase 1 Study To Evaluate The Safety And Tolerability Of Different Doses Of PF-03526299 In Healthy Adult Volunteers', '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 Multiple Inhaled Doses Of PF-03526299 In Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'A9291003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PF-03526299 1.396 mg', 'interventionNames': ['Drug: PF-03526299']}, {'type': 'EXPERIMENTAL', 'label': 'PF-03526299 4mg', 'interventionNames': ['Drug: PF-03526299']}], 'interventions': [{'name': 'PF-03526299', 'type': 'DRUG', 'description': 'dry powder for inhalation, 1.396 mg, BID for 14 days', 'armGroupLabels': ['PF-03526299 1.396 mg']}, {'name': 'PF-03526299', 'type': 'DRUG', 'description': 'dry powder for inhalation, 4 mg, BID for 14 days', 'armGroupLabels': ['PF-03526299 4mg']}]}, '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.'}}}}