Ignite Creation Date:
2025-12-24 @ 4:59 PM
Ignite Modification Date:
2025-12-28 @ 3:54 AM
Study NCT ID:
NCT01924650
Status:
WITHDRAWN
Last Update Posted:
2013-12-20
First Post:
2013-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pharmacokinetic Study of Three Different Particle Sizes of PH-797804
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C542398', 'term': 'PH 797804'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-12-19', 'studyFirstSubmitDate': '2013-08-14', 'studyFirstSubmitQcDate': '2013-08-14', 'lastUpdatePostDateStruct': {'date': '2013-12-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Curve From Time Zero to Time 72 hours (AUC72)', 'timeFrame': '0,2,3,4,5,6,8,12,24,48,72 hours post-dose', 'description': 'Area under the plasma concentration time-curve from zero to 72 hours (AUC72)'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax)', 'timeFrame': '0,2,3,4,5,6,8,12,24,48,72 hours post-dose'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax)', 'timeFrame': '0,2,3,4,5,6,8,12,24,48,72 hours post-dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6631040&StudyName=A%20Pharmacokinetic%20Study%20of%20Three%20Different%20Particle%20Sizes%20of%20PH-797804', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effects of varying particle size on the pharmacokinetics of PH-797804'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male subjects and/or healthy female subjects of non-child bearing potential 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 measurements, 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 \\> 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 males.'}, 'identificationModule': {'nctId': 'NCT01924650', 'briefTitle': 'A Pharmacokinetic Study of Three Different Particle Sizes of PH-797804', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Randomized, Open Label, Single Dose, 6 Treatment, 4-way Crossover Study in Healthy Subjects to Assess the Pharmacokinetics of Three Different Particle Sizes of PH-797804 Tablet With and Without the Solubilizing Agent Sodium Lauryl Sulphate (SLS)', 'orgStudyIdInfo': {'id': 'A6631040'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PH-797804 PARTICLE SIZE 9-11UM', 'interventionNames': ['Drug: PH-797804']}, {'type': 'EXPERIMENTAL', 'label': 'PH-797804 PARTICLE SIZE 9-11UM WITH SLS', 'interventionNames': ['Drug: PH-797804']}, {'type': 'EXPERIMENTAL', 'label': 'PH-797804 PARTICLE SIZE <= 20UM', 'interventionNames': ['Drug: PH-797804']}, {'type': 'EXPERIMENTAL', 'label': 'PH-797804 PARTICLE SIZE <= 20UM WITH SLS', 'interventionNames': ['Drug: PH-797804']}, {'type': 'EXPERIMENTAL', 'label': 'PH-797804 PARTICLE SIZE <= 5UM', 'interventionNames': ['Drug: PH-797804']}, {'type': 'EXPERIMENTAL', 'label': 'PH-797804 PARTICLE SIZE <= 5UM WITH SLS', 'interventionNames': ['Drug: PH-797804']}], 'interventions': [{'name': 'PH-797804', 'type': 'DRUG', 'description': 'Tablet, 6 mg, single dose', 'armGroupLabels': ['PH-797804 PARTICLE SIZE 9-11UM']}, {'name': 'PH-797804', 'type': 'DRUG', 'description': 'Tablet, 6 mg, single dose', 'armGroupLabels': ['PH-797804 PARTICLE SIZE 9-11UM WITH SLS']}, {'name': 'PH-797804', 'type': 'DRUG', 'description': 'Tablet, 6 mg, single dose', 'armGroupLabels': ['PH-797804 PARTICLE SIZE <= 20UM']}, {'name': 'PH-797804', 'type': 'DRUG', 'description': 'Tablet, 6 mg, single dose', 'armGroupLabels': ['PH-797804 PARTICLE SIZE <= 20UM WITH SLS']}, {'name': 'PH-797804', 'type': 'DRUG', 'description': 'Tablet, 6 mg, single dose', 'armGroupLabels': ['PH-797804 PARTICLE SIZE <= 5UM']}, {'name': 'PH-797804', 'type': 'DRUG', 'description': 'Tablet, 6 mg, single dose', 'armGroupLabels': ['PH-797804 PARTICLE SIZE <= 5UM WITH SLS']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}