Ignite Creation Date:
2025-12-24 @ 12:38 PM
Ignite Modification Date:
2026-01-25 @ 1:14 AM
Study NCT ID:
NCT03777761
Status:
COMPLETED
Last Update Posted:
2019-04-12
First Post:
2018-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Tucatinib on Cardiac Repolarization in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000705452', 'term': 'tucatinib'}, {'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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'The study will be double-blind in regard to tucatinib and placebo study treatments and open-label for the positive control, moxifloxacin.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-03-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-11', 'studyFirstSubmitDate': '2018-12-10', 'studyFirstSubmitQcDate': '2018-12-13', 'lastUpdatePostDateStruct': {'date': '2019-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Placebo-corrected change-from-baseline in QTcF', 'timeFrame': 'Up to 32 days', 'description': "QTcF is the QT interval corrected for heart rate using Fridericia's method."}], 'secondaryOutcomes': [{'measure': 'Change from baseline in heart rate (HR)', 'timeFrame': 'Up to 32 days'}, {'measure': 'Change from baseline in QTcF', 'timeFrame': 'Up to 32 days'}, {'measure': 'Change from baseline in PR interval', 'timeFrame': 'Up to 32 days'}, {'measure': 'Change from baseline in QRS interval', 'timeFrame': 'Up to 32 days'}, {'measure': 'Placebo-corrected change from baseline in HR', 'timeFrame': 'Up to 32 days'}, {'measure': 'Placebo-corrected change from baseline in PR interval', 'timeFrame': 'Up to 32 days'}, {'measure': 'Placebo-corrected change from baseline in QRS interval', 'timeFrame': 'Up to 32 days'}, {'measure': '• Number of participants who experience increases in absolute QTcF interval values >450 msec', 'timeFrame': 'Up to 32 days'}, {'measure': '• Number of participants who experience QTcF interval changes from predose baseline of >30msec', 'timeFrame': 'Up to 32 days'}, {'measure': '• Number of participants who experience an increase in PR interval from predose baseline of >25% to a PR >200 msec', 'timeFrame': 'Up to 32 days'}, {'measure': '• Number of participants who experience an increase in QRS interval from predose baseline >25% to a QRS >120 msec', 'timeFrame': 'Up to 32 days'}, {'measure': '• Number of participants who experience a decrease in heart rate >25% from baseline to a heart rate <50', 'timeFrame': 'Up to 32 days'}, {'measure': '• Number of participants who experience an increase in heart rate >25% from baseline to a heart rate >100', 'timeFrame': 'Up to 32 days'}, {'measure': 'Frequency of treatment-emergent changes of T-wave morphology and U-wave presence', 'timeFrame': 'Up to 32 days'}, {'measure': 'Area under the concentration-time curve (AUC) from time 0 extrapolated to infinity (AUC[0-inf]) for tucatinib and ONT-993', 'timeFrame': 'Up to 26 days'}, {'measure': 'AUC from time 0 to the time of the last quantifiable concentration for tucatinib and ONT-993', 'timeFrame': 'Up to 26 days'}, {'measure': 'Percentage of AUC[0-inf] due to extrapolation for tucatinib and ONT-993', 'timeFrame': 'Up to 26 days'}, {'measure': 'Maximum observed concentration for tucatinib and ONT-993', 'timeFrame': 'Up to 26 days'}, {'measure': 'Time of maximum observed concentration for tucatinib and ONT-993', 'timeFrame': 'Up to 26 days'}, {'measure': 'Apparent terminal elimination half-life for tucatinib and ONT-993', 'timeFrame': 'Up to 26 days'}, {'measure': 'Apparent total clearance for tucatinib', 'timeFrame': 'Up to 26 days'}, {'measure': 'Apparent volume of distribution during the terminal phase for tucatinib', 'timeFrame': 'Up to 26 days'}, {'measure': 'Metabolic ratio based on AUC for ONT-993', 'timeFrame': 'Up to 26 days'}, {'measure': 'Incidence of adverse events (AEs)', 'timeFrame': 'Up to 32 days'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '37751113', 'type': 'DERIVED', 'citation': 'Topletz-Erickson AR, Mayor JG, Liu HT, Abdulrasool LI, Endres CJ. Effect of Tucatinib on Cardiac Repolarization in Healthy Volunteers. Drugs R D. 2023 Dec;23(4):411-419. doi: 10.1007/s40268-023-00440-8. Epub 2023 Sep 26.'}]}, 'descriptionModule': {'briefSummary': 'This study is looking at how the study drug, tucatinib, affects the heart. Tucatinib is being studied as a possible treatment for breast cancer. This study will recruit healthy volunteers. There are 3 parts in the study. Each volunteer will be in all 3 parts. One part will be to take the study drug, the second part will be to take a placebo (pill with no medicine), and the third part will be to take moxifloxacin. The volunteers will only know what part of the study they are in when they take moxifloxacin. For the study drug and placebo parts, volunteers will take 2 pills by mouth for 5 days. For the moxifloxacin part, volunteers will take 1 pill by mouth for 1 day.', 'detailedDescription': "This study will evaluate the effects of a steady state therapeutic dose of tucatinib on QTcF (QT interval corrected for heart rate using Fridericia's method) in healthy individuals. In this design, study treatment will be dosed in 3 sequential treatment periods:\n\nTreatment A: Oral doses of 300mg tucatinib for 5 days\n\nTreatment B: Oral doses of matching placebo for tucatinib for 5 days\n\nTreatment C: A single oral dose of 400 mg of moxifloxacin\n\nPatients will be randomized based on 2-Williams-square design to 1 of 6 treatment sequences to maintain the study blind for tucatinib and placebo."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Good health, determined by medical history, physical examination, 12-lead ECG, vital signs measurements, or clinical laboratory evaluations\n* Body mass index (BMI) between 18 and 32 kg/m\\^2\n* Body weight between 50 and 100 kg\n* Female subjects must be of non-childbearing potential\n* Male subjects must agree to use contraception or be surgically sterile for at least 90 days\n\nExclusion Criteria:\n\n* Significant history of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder\n* Any condition affecting drug absorption\n* History of hypersensitivity or allergy to any drug compound, food, or other substance\n* Single 12-lead ECG demonstrating QTcF \\>450 msec for males or \\>470 msec for females, or history/evidence of long QT syndrome\n* History of alcoholism or drug/chemical abuse within 2 years\n* Use of prescription products within 30 days prior to check in\n* Use of nonprescription products within 14 days prior to check in, including vitamins, minerals, and herbal supplements\n* Use of tobacco- or nicotine-containing products within 3 months prior to check in'}, 'identificationModule': {'nctId': 'NCT03777761', 'briefTitle': 'Effects of Tucatinib on Cardiac Repolarization in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Seagen Inc.'}, 'officialTitle': 'A Phase 1, Randomized, Partially Double-Blind, Placebo- and Positive-controlled Study to Evaluate the Effect of Tucatinib on Cardiac Repolarization in Healthy Subjects', 'orgStudyIdInfo': {'id': 'ONT-380-011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Sequence ABC', 'description': 'tucatinib + placebo + moxifloxacin (administered in sequential treatment periods)', 'interventionNames': ['Drug: tucatinib', 'Drug: placebo', 'Drug: moxifloxacin']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Sequence CAB', 'description': 'moxifloxacin + tucatinib + placebo (administered in sequential treatment periods)', 'interventionNames': ['Drug: tucatinib', 'Drug: placebo', 'Drug: moxifloxacin']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Sequence BCA', 'description': 'placebo + moxifloxacin + tucatinib (administered in sequential treatment periods)', 'interventionNames': ['Drug: tucatinib', 'Drug: placebo', 'Drug: moxifloxacin']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Sequence CBA', 'description': 'moxifloxacin + placebo + tucatinib (administered in sequential treatment periods)', 'interventionNames': ['Drug: tucatinib', 'Drug: placebo', 'Drug: moxifloxacin']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Sequence ACB', 'description': 'tucatinib + moxifloxacin + placebo (administered in sequential treatment periods)', 'interventionNames': ['Drug: tucatinib', 'Drug: placebo', 'Drug: moxifloxacin']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Sequence BAC', 'description': 'placebo + tucatinib + moxifloxacin (administered in sequential treatment periods)', 'interventionNames': ['Drug: tucatinib', 'Drug: placebo', 'Drug: moxifloxacin']}], 'interventions': [{'name': 'tucatinib', 'type': 'DRUG', 'description': '300mg oral dose', 'armGroupLabels': ['Treatment Sequence ABC', 'Treatment Sequence ACB', 'Treatment Sequence BAC', 'Treatment Sequence BCA', 'Treatment Sequence CAB', 'Treatment Sequence CBA']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Matching placebo for tucatinib', 'armGroupLabels': ['Treatment Sequence ABC', 'Treatment Sequence ACB', 'Treatment Sequence BAC', 'Treatment Sequence BCA', 'Treatment Sequence CAB', 'Treatment Sequence CBA']}, {'name': 'moxifloxacin', 'type': 'DRUG', 'description': '400mg single oral dose', 'armGroupLabels': ['Treatment Sequence ABC', 'Treatment Sequence ACB', 'Treatment Sequence BAC', 'Treatment Sequence BCA', 'Treatment Sequence CAB', 'Treatment Sequence CBA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75247', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Covance Clinical Research Unit - Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Joseph Woolery, PharmD, BCOP', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Seagen Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seagen Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}