Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2025-12-29 @ 7:55 AM
Study NCT ID:
NCT01064804
Status:
COMPLETED
Last Update Posted:
2010-02-08
First Post:
2009-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Test The Relative Bioavailability Of PF-04191834 When Dosed As An Immediate Release Tablet Compared With Solution Following Single And Multiple Dosing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'whole blood, plasma, urine, saliva'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-02-05', 'studyFirstSubmitDate': '2009-09-01', 'studyFirstSubmitQcDate': '2010-02-05', 'lastUpdatePostDateStruct': {'date': '2010-02-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pharmacokinetic parameters of PF-04191834', 'timeFrame': 'hours'}], 'secondaryOutcomes': [{'measure': 'maximum concentration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Asthma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0041005&StudyName=To%20Test%20The%20Relative%20Bioavailability%20Of%20PF-04191834%20When%20Dosed%20As%20An%20Immediate%20Release%20Tablet%20Compared%20With%20Solution%20Following%20Single%20An', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'To test the relative bioavailability of PF-04191834 when dosed as an Immediate Release tablet compared with solution following single and multiple dosing.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'young, healthy male volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male subjects between the ages of 18 and 55 years, inclusive (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 approximately 17.5 kg/m2 to 30.5 kg/m2 and a total body weight \\> 50 kg (110 lbs).\n* An informed consent document signed and dated by the subject or a legally acceptable representative.\n* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n* Subjects who have urinary LTE4 levels greater than or equal to 30 pg/mg Creatinine at screening following spot urinary collection for Cohort 2.\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* Any condition possibly affecting drug absorption (eg, gastrectomy).\n* A positive urine drug screen.'}, 'identificationModule': {'nctId': 'NCT01064804', 'briefTitle': 'To Test The Relative Bioavailability Of PF-04191834 When Dosed As An Immediate Release Tablet Compared With Solution Following Single And Multiple Dosing', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'An Open Randomised 4-Way Crossover Single Dose And A Parallel Group Multiple Dose Comparative Pharmacokinetic Study Of The PF-04191834 Phase 2 Tablet And The Phase 1 Dispersion Formulations.', 'orgStudyIdInfo': {'id': 'B0041005'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'relative bioavailability', 'interventionNames': ['Drug: PF-04191834']}], 'interventions': [{'name': 'PF-04191834', 'type': 'DRUG', 'description': 'PF-04191834. 100mg Immediate Release Tablets or oral suspension', 'armGroupLabels': ['relative bioavailability']}]}, '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': {'oldNameTitle': 'Director, Clinical Trial Disclosure Group', 'oldOrganization': 'Pfizer, Inc.'}}}}