Ignite Creation Date:
2025-12-24 @ 12:42 PM
Ignite Modification Date:
2026-02-20 @ 11:49 PM
Study NCT ID:
NCT01775761
Status:
COMPLETED
Last Update Posted:
2013-05-21
First Post:
2013-01-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study To Determine Any Effect Of Tafamidis On Electrocardiographic Intervals, Specifically The Rate Corrected QT Interval (QTc)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C547076', 'term': 'tafamidis'}, {'id': 'D000077266', 'term': 'Moxifloxacin'}], 'ancestors': [{'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-20', 'studyFirstSubmitDate': '2013-01-15', 'studyFirstSubmitQcDate': '2013-01-22', 'lastUpdatePostDateStruct': {'date': '2013-05-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "QTc interval using Fridericia's correction method (QTcF) of tafamidis and placebo (baseline-adjusted) at each post-dose time", 'timeFrame': 'SCRN, -1, -0.5, 0, 1, 1.5, 2, 3, 4, 6, 12, 24 hrs'}], 'secondaryOutcomes': [{'measure': 'QTcF of moxifloxacin and placebo at historical moxifloxacin median Tmax of 3 hours.', 'timeFrame': 'Scrn, -1, -0.5, 0, 1, .5, 2, 3, 4, 6, 8, 12, 24 hrs'}, {'measure': 'Tmax', 'timeFrame': '0, 1, .5, 2, 3, 4, 6, 8, 12, 24 hrs'}, {'measure': 'Cmax', 'timeFrame': '0, 1, .5, 2, 3, 4, 6, 8, 12, 24 hrs'}, {'measure': 'AUC0-24', 'timeFrame': '0, 1, .5, 2, 3, 4, 6, 8, 12, 24 hrs'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Thorough QTc evaluation of tafamidis compared to the effects of moxifloxacin and placebo in healthy volunteers.'], 'conditions': ['TTR Cardiomyopathy']}, 'referencesModule': {'references': [{'pmid': '25546001', 'type': 'DERIVED', 'citation': 'Klamerus KJ, Watsky E, Moller R, Wang R, Riley S. The effect of tafamidis on the QTc interval in healthy subjects. Br J Clin Pharmacol. 2015 Jun;79(6):918-25. doi: 10.1111/bcp.12561.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B3461031&StudyName=A%20Study%20To%20Determine%20Any%20Effect%20Of%20Tafamidis%20On%20Electrocardiographic%20Intervals%2C%20Specifically%20The%20Rate%20Corrected%20QT%20Interval%20%28QTc%29', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effects of tafamidis on the intervals of the electrocardiogram, specifically the rate corrected QT interval (QTc) in healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy, nonsmoking, male and/or female subjects of non-childbearing potential.\n* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.\n* Total body weight \\>50 kg (110 lbs).\n\nExclusion Criteria:\n\n* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.\n* An ALT or AST measurement \\>2 times the ULN.\n* 12-lead ECG demonstrating QTc \\>450 msec or a QRS interval \\>120 msec at Screening.\n* Subjects at increased risk if dosed with moxifloxacin, according to the product label for moxifloxacin.\n* History of risk factors of QT prolongation or torsades de pointes, congenital deafness and family history of sudden death.'}, 'identificationModule': {'nctId': 'NCT01775761', 'briefTitle': 'A Study To Determine Any Effect Of Tafamidis On Electrocardiographic Intervals, Specifically The Rate Corrected QT Interval (QTc)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Randomized, Placebo- And Positive-Controlled Cross-Over Study To Evaluate The Effect Of Tafamidis On The QTC Interval In Healthy Volunteers', 'orgStudyIdInfo': {'id': 'B3461031'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Period 1: 960 mg tafamidis (Vyndaqel)', 'interventionNames': ['Drug: Period 1']}, {'type': 'EXPERIMENTAL', 'label': 'Period 2: 400 mg moxifloxacin', 'description': '400 mg moxifloxacin', 'interventionNames': ['Drug: Period 2']}, {'type': 'EXPERIMENTAL', 'label': 'Period 3: Placebo', 'interventionNames': ['Drug: Period 3']}], 'interventions': [{'name': 'Period 1', 'type': 'DRUG', 'otherNames': ['tafamidis (Vyndaqel)'], 'description': 'A comparison of less than or equal to 960 mg tafamidis, 400 mg moxifloxacin and placebo on the rate corrected QT interval.', 'armGroupLabels': ['Period 1: 960 mg tafamidis (Vyndaqel)']}, {'name': 'Period 2', 'type': 'DRUG', 'otherNames': ['moxifloxacin'], 'description': 'A comparison of less than or equal to 960 mg tafamidis, 400 mg moxifloxacin and placebo on the rate corrected QT interval.', 'armGroupLabels': ['Period 2: 400 mg moxifloxacin']}, {'name': 'Period 3', 'type': 'DRUG', 'description': 'A comparison of less than or equal to 960 mg tafamidis, 400 mg moxifloxacin and placebo on the rate corrected QT interval.', 'armGroupLabels': ['Period 3: Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': 'B-1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '188770', 'city': 'Singapore', 'state': 'Singapore', 'country': 'Singapore', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}