Ignite Creation Date:
2025-12-24 @ 12:23 PM
Ignite Modification Date:
2026-02-06 @ 3:16 AM
Study NCT ID:
NCT02163161
Status:
COMPLETED
Last Update Posted:
2014-08-18
First Post:
2014-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AStudy to Evaluate the Bioavailability of PF 04965842 in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005215', 'term': 'Fasting'}, {'id': 'D007863', 'term': 'Lecithin Cholesterol Acyltransferase Deficiency'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D052456', 'term': 'Hypoalphalipoproteinemias'}, {'id': 'D007009', 'term': 'Hypolipoproteinemias'}, {'id': 'D008052', 'term': 'Lipid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000634427', 'term': 'abrocitinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-15', 'studyFirstSubmitDate': '2014-06-11', 'studyFirstSubmitQcDate': '2014-06-11', 'lastUpdatePostDateStruct': {'date': '2014-08-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Curve from Time Zero to infinity (AUC inf)', 'timeFrame': '15 days'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax)', 'timeFrame': '15 days'}, {'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)', 'timeFrame': '15 days', 'description': 'Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)'}], 'secondaryOutcomes': [{'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax)', 'timeFrame': '15 days'}, {'measure': 'Plasma Decay Half-Life (t1/2)', 'timeFrame': '15 days', 'description': 'Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Phase I', 'Open Label', 'Single dose', 'Crossover', 'Bioavailability', 'Fasting', 'Fed', 'PF-04965842', 'Healthy'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '35061234', 'type': 'DERIVED', 'citation': 'Wojciechowski J, Malhotra BK, Wang X, Fostvedt L, Valdez H, Nicholas T. Population Pharmacokinetics of Abrocitinib in Healthy Individuals and Patients with Psoriasis or Atopic Dermatitis. Clin Pharmacokinet. 2022 May;61(5):709-723. doi: 10.1007/s40262-021-01104-z. Epub 2022 Jan 21.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7451004&StudyName=AStudy%20to%20Evaluate%20the%20Bioavailability%20of%20%20PF%2004965842%20in%20Healthy%20Subjects%20', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'Phase 1, open label, single dose, 3 way crossover study to evaluate the bioavailability of a solid dose formulation of PF 04965842 relative to a suspension formulation under fasting conditions and the effect of food on the bioavailability of the solid dosage formulation of PF 04965842 in healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male subjects and female subjects of non childbearing potential between the ages of 18 and 55 years, inclusive.\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* Subjects who received within 7 days prior to the first dose of study medication or are likely to receive during the study any moderate strong inhibitors of CYP3A4, eg, itraconazole, erythromycin, ketoconazole, protease inhibitors, verapamil, or diltiazem.\n* Subjects who received within 28 days or are likely to receive during the study inducers of CYP3A4, eg rifampin.'}, 'identificationModule': {'nctId': 'NCT02163161', 'briefTitle': 'AStudy to Evaluate the Bioavailability of PF 04965842 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 1, Open Label, Single Dose 3 Way Crossover Study to Evaluate the Bioavailability of a Solid Dose Formulation of PF 04965842 Relative to a Suspension Formulation Under Fasting Conditions and the Effect of Food on the Bioavailability of the Solid Dosage Formulation of Pf 04965842 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'B7451004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment A', 'interventionNames': ['Drug: PF-04965842']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment B', 'interventionNames': ['Drug: PF-04965842']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment C', 'interventionNames': ['Drug: PF- 04965842']}], 'interventions': [{'name': 'PF-04965842', 'type': 'DRUG', 'description': 'Subjects will receive 4 x 100 mg PF 04965842 tablet under fasted conditions', 'armGroupLabels': ['Treatment A']}, {'name': 'PF-04965842', 'type': 'DRUG', 'description': 'Subjects will receive 400 mg PF 04965842 oral suspension under fasted conditions', 'armGroupLabels': ['Treatment B']}, {'name': 'PF- 04965842', 'type': 'DRUG', 'description': 'Subjects will receive 4 x 100 mg PF 04965842 tablet under fed conditions', 'armGroupLabels': ['Treatment C']}]}, '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': {'type': 'SPONSOR'}}}}