Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-03-03 @ 2:32 AM
Study NCT ID:
NCT03821493
Status:
COMPLETED
Last Update Posted:
2019-06-28
First Post:
2019-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Multiple Doses of Itraconazole on the Pharmacokinetics of a Single-Dose of PF-06651600 in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000614924', 'term': 'PF-06651600'}, {'id': 'D017964', 'term': 'Itraconazole'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2019-06-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-27', 'studyFirstSubmitDate': '2019-01-28', 'studyFirstSubmitQcDate': '2019-01-28', 'lastUpdatePostDateStruct': {'date': '2019-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Single dose Area under the curve from time zero to infinity [AUC (0-inf)] of PF-06651600', 'timeFrame': '0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 and 48 hours', 'description': 'Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinity.'}, {'measure': 'Maximum observed plasma concentration of PF-06651600', 'timeFrame': '0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 and 48 hours', 'description': 'Peak concentration of PF-06651600'}], 'secondaryOutcomes': [{'measure': 'Incidence of treatment-emergent adverse events (AEs)', 'timeFrame': 'Baseline up to 35 days'}, {'measure': 'Number of adverse events leading to discontinuation', 'timeFrame': 'Baseline up to 35 days'}, {'measure': 'Number of participants with clinically significant change in vital signs from Baseline', 'timeFrame': 'Baseline to Day 9'}, {'measure': 'Number of participants with clinically significant abnormalities in clinical laboratory values', 'timeFrame': 'Baseline to Day 9'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PF-06651600', 'Itraconazole', 'CYP3A4', 'Drug-Drug Interaction'], 'conditions': ['Healthy Participants']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981023&StudyName=A+PHASE+1%2C+OPEN-LABEL%2C+FIXED+SEQUENCE+2-PERIOD+STUDY+TO+INVESTIGATE+THE+EFFECT+OF+MULTIPLE+DOSES+OF+ITRACONAZOLE+ON+THE+PHARMACOKINETICS+OF+A+SINGLE+DOSE+OF+PF-06651600+IN+HEALTHY+PARTICIPANTS', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This study will estimate the impact of a strong CYP3A4 inhibitor (itraconazole) on the pharmacokinetics of an investigational product (PF-06651600) in healthy adult participants.\n\nThis is an open-label, fixed sequence two period study with healthy participants that will receive a single dose of PF-06651600 alone and co-administered with multiple doses of itraconazole at a single center.\n\nParticipants will be screened within 28 days of the first dose of the investigational products and if entry criteria are met, the participant will report to the clinic on the day before the Day 1 visit. On Day 1 of Period 1, each participant will receive a 30 mg dose of PF-06651600 and PK samples will be collected for 48 hours. In Period 2, participants will receive itraconazole solution from Day 1-5. On Day 4 of Period 2 the participant will receive 30 mg of PF-06651600 with the itraconazole. PK samples will be collected up to 48 hours after the PF-06651600 dose. Participants will be confined for a total of 9 days in the clinic. The participant will be followed up by phone contact.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations and other study procedures.\n* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \\>50 kg.\n\nExclusion Criteria:\n\n* Evidence of congestive heart failure or history of congestive heart failure or any of the following: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, cerebrovascular accident including transient ischemic attack or pulmonary embolus.\n* Known hypersensitivity to itraconazole or it excipients or to other azole antifungals.\n* Infection with Hepatitis B, C or HIV\n* Known present or history of malignancy other than a successfully treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.'}, 'identificationModule': {'nctId': 'NCT03821493', 'briefTitle': 'Effect of Multiple Doses of Itraconazole on the Pharmacokinetics of a Single-Dose of PF-06651600 in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 1, OPEN-LABEL, FIXED SEQUENCE 2-PERIOD STUDY TO INVESTIGATE THE EFFECT OF MULTIPLE DOSES OF ITRACONAZOLE ON THE PHARMACOKINETICS OF A SINGLE DOSE OF PF-06651600 IN HEALTHY PARTICIPANTS', 'orgStudyIdInfo': {'id': 'B7981023'}, 'secondaryIdInfos': [{'id': '2018-004664-55', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PF-06651600 treatment arm', 'description': 'This arm includes two treatment periods. Period 1-Single oral dose of PF-06651600 30 mg as tablets on Day 1 followed by Period 2 in which itraconazole 200 mg (oral solution) is given for 5 days. On Day 4 of Period 2, a single oral dose of PF-06651600 30 mg is given with itraconazole', 'interventionNames': ['Drug: PF-06651600 10 mg tablets', 'Drug: Itraconazole Solution 200 mg']}], 'interventions': [{'name': 'PF-06651600 10 mg tablets', 'type': 'DRUG', 'description': 'On Day 1 in Period 1, a single oral dose of 30 mg (3 x 10 mg tablets) will be administered.\n\nOn Day 4 of Period 2, a single oral dose of 30 mg (3 x 10 mg tablets) will be administered after itraconazole.', 'armGroupLabels': ['PF-06651600 treatment arm']}, {'name': 'Itraconazole Solution 200 mg', 'type': 'DRUG', 'otherNames': ['Sporanox Oral Solution'], 'description': 'Itraconazole 200 mg will be administered as 20 mL (10 mg/mL) oral solution once daily on Days 1-5 in Period 2.\n\nOn Day 4 of Period 2, co-administration of itraconazole 200 mg and PF-06651600 30 mg will occur. Itraconazole will be administered first followed by PF-06651600 tablets.', 'armGroupLabels': ['PF-06651600 treatment arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B-1070', 'city': 'Brussels', 'state': 'Be-bru', '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': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}