Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2026-06-13 @ 6:36 PM
Study NCT ID:
NCT03266705
Status:
COMPLETED
Last Update Posted:
2018-05-14
First Post:
2017-08-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Comparing Amounts of 2 Different Forms of Tafamidis (PF-6291826) in the Blood
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C547076', 'term': 'tafamidis'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-11', 'studyFirstSubmitDate': '2017-08-28', 'studyFirstSubmitQcDate': '2017-08-28', 'lastUpdatePostDateStruct': {'date': '2018-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the concentration-time curve (AUC)', 'timeFrame': '24 hours'}, {'measure': 'maximum observed plasma concentration (Cmax)', 'timeFrame': '24 hours'}], 'secondaryOutcomes': [{'measure': 'minimum observed plasma concentration (Cmin)', 'timeFrame': '24 hours'}, {'measure': 'Time to maximum observed plasma concentration (Tmax)', 'timeFrame': '24 hours'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B3461056&StudyName=A+Phase+1%2C+Open-label%2C+Randomized%2C+Crossover%2C+Multiple+Dose%2C+Pivotal+Bioequivalence+Study+To+Compare+Pf-06291826+4+X+20+Mg+Tafamidis+Meglumine+And+61+Mga+Tafamidis+Free+Acid+Soft+Gelatin+Capsules+Administered+Under+Fasted+Conditions+To+Healthy+Volunteers', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': '2 different formulations and doses of tafamidis will be compared. All subjects will receive both doses/formulations. Subjects will take tafamidis for 7 days, on the first 2 days they will take tafamidis twice, 12 hours apart and then once a day for the next 5 days. Subjects will be fasted before taking the drug. Blood samples will be taken to measure the amount of tafamidis starting on day 7 and ending on day 8. At least 16 days after the first formulation/dose is given, all subjects will repeat the procedure with the other formulation/dose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy males of females of non-childbearing potential\n* Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \\>50 kg (110 lb)\n\nExclusion Criteria:\n\n* Blood pressure at screening visit of greater than 140 mm Hg (systolic) or 90 mg Hg (diastolic).\n* Use of prescription or nonprescription drugs supplements within 7 days prior to 7 days of the study.\n* Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of investigational product (whichever is longer)\n* Pregnant female subjects; breastfeeding female subjects; male subjects with partners currently pregnant; male subjects able to father children who are unwilling or unable to use a highly effective method of contraception.'}, 'identificationModule': {'nctId': 'NCT03266705', 'briefTitle': 'A Study Comparing Amounts of 2 Different Forms of Tafamidis (PF-6291826) in the Blood', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 1, Open-label, Randomized, Crossover, Multiple Dose, Pivotal Bioequivalence Study To Compare Pf-06291826 4 X 20 Mg Tafamidis Meglumine And 61 Mga Tafamidis Free Acid Soft Gelatin Capsules Administered Under Fasted Conditions To Healthy Volunteers', 'orgStudyIdInfo': {'id': 'B3461056'}, 'secondaryIdInfos': [{'id': '2017-002572-15', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '61 mgA tafamidis free acid soft gelatin capsule', 'interventionNames': ['Drug: tafamidis']}, {'type': 'EXPERIMENTAL', 'label': '4x20 mg tafamidis meglumine soft gelatin capsule', 'interventionNames': ['Drug: tafamidis']}], 'interventions': [{'name': 'tafamidis', 'type': 'DRUG', 'description': 'bioequivalence study', 'armGroupLabels': ['4x20 mg tafamidis meglumine soft gelatin capsule', '61 mgA tafamidis free acid soft gelatin capsule']}]}, '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'}}}}