Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-04-25 @ 12:35 PM
Study NCT ID:
NCT03232905
Status:
COMPLETED
Last Update Posted:
2017-12-06
First Post:
2017-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Pharmacokinetic Study of PF-06651600 in Japanese Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000614924', 'term': 'PF-06651600'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-11-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-04', 'studyFirstSubmitDate': '2017-07-25', 'studyFirstSubmitQcDate': '2017-07-25', 'lastUpdatePostDateStruct': {'date': '2017-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs', 'timeFrame': 'Baseline up to Day 45'}, {'measure': 'Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS interval, QT Interval, QTC Interval, heart rate)', 'timeFrame': 'Baseline, 1 hour post-dose on Day 1 and 10'}, {'measure': 'Change From Baseline in Vital Signs (Blood Pressure, Pulse Rate, Oral Temperature)', 'timeFrame': 'Baseline, Day 1, 10, 12 and 28'}, {'measure': 'Number of Participants With Change From Baseline in Physical Examinations', 'timeFrame': 'Baseline up to Day 28'}, {'measure': 'Number of Participants With Laboratory Abnormalities', 'timeFrame': 'Baseline up to Day 28'}], 'secondaryOutcomes': [{'measure': 'Maximum Observed Plasma Concentration (Cmax) of PF-06651600 at Day 1', 'timeFrame': 'pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) of PF-06651600 at Day 10', 'timeFrame': 'pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06651600 at Day 1', 'timeFrame': 'pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06651600 at Day 10', 'timeFrame': 'pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10'}, {'measure': 'Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06651600 at Day 1', 'timeFrame': 'pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1'}, {'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06651600 at Day 1', 'timeFrame': 'pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1'}, {'measure': 'Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06651600 at Day 1', 'timeFrame': 'pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1'}, {'measure': 'Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06651600 at Day 10', 'timeFrame': 'pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10'}, {'measure': 'Plasma Decay Half-Life (t1/2) of PF-06651600 at Day 1', 'timeFrame': 'pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1'}, {'measure': 'Plasma Decay Half-Life (t1/2) of PF-06651600 at Day 10', 'timeFrame': 'pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10'}, {'measure': 'Observed Accumulation Ratio (Rac) on AUCtau for PF-06651600 at Day 10', 'timeFrame': 'pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10'}, {'measure': 'Observed Accumulation Ratio on Cmax (RacCmax) for PF-06651600 at Day 10', 'timeFrame': 'pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10'}, {'measure': 'MinimumObserved Plasma Concentration (Cmin) of PF-06651600 at Day 10', 'timeFrame': 'pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'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.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981008&StudyName=A+Phase+1%2C+Randomized%2C+Double-blind%2C+Third-party+Open%2C+Placebo-controlled+Study+To+Evaluate+The+Safety%2C+Tolerability%2C+And+Pharmacokinetics+After+Multiple+Oral+Doses+Of+Pf-06651600+In+Healthy+Japanese+Subjects', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This study is a phase 1 study of PF-06651600. PF-06651600 is being developed for treatment of inflammatory bowel disease. The goal of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-06651600 after multiple oral doses of PF-06651600 in Japanese healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject must have four Japanese grandparents who were born in Japan.\n* Healthy male subjects and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive\n* No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)\n* BMI of 17.5 to 27.5 kg/m2; and a total body weight \\>50 kg (110 lbs).\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* Males of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product\n* Use of tobacco/nicotine containing products in excess of 5 cigarettes/day.\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': 'NCT03232905', 'briefTitle': 'Safety and Pharmacokinetic Study of PF-06651600 in Japanese Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 1, Randomized, Double-blind, Third-party Open, Placebo-controlled Study To Evaluate The Safety, Tolerability, And Pharmacokinetics After Multiple Oral Doses Of Pf-06651600 In Healthy Japanese Subjects', 'orgStudyIdInfo': {'id': 'B7981008'}, 'secondaryIdInfos': [{'id': '2017-001298-17', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PF-06651600', 'description': 'Multiple ascending doses of PF-06651600', 'interventionNames': ['Drug: PF-06651600']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Multiple ascending doses of Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'PF-06651600', 'type': 'DRUG', 'description': 'PF-06651600 will be administered as tablet', 'armGroupLabels': ['PF-06651600']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo will be administered as tablet', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B-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'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}