Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-03-09 @ 4:16 AM
Study NCT ID:
NCT02684760
Status:
COMPLETED
Last Update Posted:
2016-06-16
First Post:
2016-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioavailability Study Of PF-06651600 In Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000614924', 'term': 'PF-06651600'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-14', 'studyFirstSubmitDate': '2016-02-12', 'studyFirstSubmitQcDate': '2016-02-12', 'lastUpdatePostDateStruct': {'date': '2016-06-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-06651600', 'timeFrame': '0, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose', 'description': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)'}, {'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06651600', 'timeFrame': '0, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose', 'description': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Cmax) for PF-06651600', 'timeFrame': '0, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose', 'description': 'Time to Reach Maximum Observed Plasma Concentration (Cmax)'}], 'secondaryOutcomes': [{'measure': 'Plasma Decay Half Life (t1/2) for PF-06651600', 'timeFrame': '0, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose', 'description': 'Plasma Decay Half-Life (t1/2)'}, {'measure': 'Time to Reach Maximum Concentration (Tmax) for PF-06651600', 'timeFrame': '0, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose', 'description': 'Time to Reach Maximum Concentration (Tmax)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Inflammatory Bowel Disease'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '38267790', 'type': 'DERIVED', 'citation': 'Saadeddin A, Purohit V, Huh Y, Wong M, Maulny A, Dowty ME, Sagawa K. Virtual Bioequivalence Assessment of Ritlecitinib Capsules with Incorporation of Observed Clinical Variability Using a Physiologically Based Pharmacokinetic Model. AAPS J. 2024 Jan 24;26(1):17. doi: 10.1208/s12248-024-00888-9.'}, {'pmid': '37917289', 'type': 'DERIVED', 'citation': 'Wojciechowski J, S Purohit V, Huh Y, Banfield C, Nicholas T. Evolution of Ritlecitinib Population Pharmacokinetic Models During Clinical Drug Development. Clin Pharmacokinet. 2023 Dec;62(12):1765-1779. doi: 10.1007/s40262-023-01318-3. Epub 2023 Nov 2.'}, {'pmid': '36977960', 'type': 'DERIVED', 'citation': 'Purohit V, Huh Y, Wojciechowski J, Plotka A, Salts S, Antinew J, Dimitrova A, Nicholas T. Leveraging Prior Healthy Participant Pharmacokinetic Data to Evaluate the Impact of Renal and Hepatic Impairment on Ritlecitinib Pharmacokinetics. AAPS J. 2023 Mar 28;25(3):32. doi: 10.1208/s12248-023-00792-8.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981003&StudyName=A+Phase+1%2C+Open+Label%2C+Single-dose+3-way+Crossover+Study+To+Evaluate+The+Relative+Bioavailability+Of+A+Solid+Dose+Formulation+Of+Pf-06651600+Under+Fasting+Conditions+And+The+Effect+Of+A+High+Fat+Meal+On+The+Bioavailability+Of+The+Solid+Dosage+Formulation+Of+Pf-06651600+In+Healthy+Subjects', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'PF-06651600 is being developed for treatment of inflammatory bowel disease. This study will test the bioavailability of a solid dose formulation of PF-06651600 compared to an oral solution formulation under fasting conditions and the effect of a high fat meal on the bioavailability of the solid dose formulation of PF-06651600 in healthy subjects. Safety and tolerability of the tablet and oral solution formulations of PF-06651600 will be assessed under fasting and fed conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male/female subjects between 18 and 55 years old, inclusive. Females must be of non-child bearing potential.\n* BMI of 17.5 to 30.5 kg/m2; and a total body weight \\>50 kg (110 lbs).\n* Prior history of chicken pox.\n* Evidence of personally signed and dated informed consent document.\n* Willing and able to comply with scheduled visits, treatment plan, lab tests and other study procedures.\n\nExclusion Criteria:\n\n* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, GI, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.\n* History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males.\n* Screening blood pressure \\>140/90 mm Hg.\n* Screening laboratory abnormalities as defined by the protocol.\n* Unwilling or unable to comply with the Lifestyle Guidelines as defined by the protocol.'}, 'identificationModule': {'nctId': 'NCT02684760', 'briefTitle': 'Bioavailability Study Of PF-06651600 In Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 1, Open Label, Single-dose 3-way Crossover Study To Evaluate The Relative Bioavailability Of A Solid Dose Formulation Of Pf-06651600 Under Fasting Conditions And The Effect Of A High Fat Meal On The Bioavailability Of The Solid Dosage Formulation Of Pf-06651600 In Healthy Subjects', 'orgStudyIdInfo': {'id': 'B7981003'}, 'secondaryIdInfos': [{'id': '2015-004857-41', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1: PF-06651600', 'description': 'Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability.', 'interventionNames': ['Drug: PF-06651600']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2: PF-06651600', 'description': 'Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability.', 'interventionNames': ['Drug: PF-06651600']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3: PF-06651600', 'description': 'Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability.', 'interventionNames': ['Drug: PF-06651600']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 4: PF-06651600', 'description': 'Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability.', 'interventionNames': ['Drug: PF-06651600']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 5: PF-06651600', 'description': 'Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability.', 'interventionNames': ['Drug: PF-06651600']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 6: PF-06651600', 'description': 'Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability.', 'interventionNames': ['Drug: PF-06651600']}], 'interventions': [{'name': 'PF-06651600', 'type': 'DRUG', 'description': 'PF-06651600 will be administered as a tablet and extemporaneously prepared solution in each cohort.', 'armGroupLabels': ['Cohort 1: PF-06651600', 'Cohort 2: PF-06651600', 'Cohort 3: PF-06651600', 'Cohort 4: PF-06651600', 'Cohort 5: PF-06651600', 'Cohort 6: PF-06651600']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Pfizer Clinical Research Unit', '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'}}}}