Ignite Creation Date:
2025-12-24 @ 9:36 PM
Ignite Modification Date:
2026-01-01 @ 4:51 PM
Study NCT ID:
NCT02365532
Status:
COMPLETED
Last Update Posted:
2015-05-20
First Post:
2015-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Oral GS-6615 on Dofetilide-Induced QT Prolongation, Safety, and Tolerability in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008133', 'term': 'Long QT Syndrome'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000624281', 'term': 'eleclazine'}, {'id': 'C063533', 'term': 'dofetilide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-19', 'studyFirstSubmitDate': '2015-02-13', 'studyFirstSubmitQcDate': '2015-02-13', 'lastUpdatePostDateStruct': {'date': '2015-05-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in daytime QT interval corrected for heart rate using the Fridericia formula (QTcF)', 'timeFrame': 'Up to 6 days'}, {'measure': 'Pharmacokinetic (PK) profiles of GS-6615 and dofetilide', 'timeFrame': 'Predose and postdose on Days -2 through Day 4', 'description': 'This endpoint will measure the plasma PK profiles of GS-6615 and dofetilide. PK parameters that will be measured include Cmax, Tmax, AUC\\_0-24, and AUC\\_0-tlast.'}], 'secondaryOutcomes': [{'measure': 'Incidence of adverse events, clinical laboratory test results, vital sign measurements, and electrocardiogram (ECG) data', 'timeFrame': 'Up to 6 days', 'description': 'This endpoint will measure the safety and tolerability profile of GS-6615.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['drug-induced long QT syndrome', 'DILQTS', 'prolonged QT'], 'conditions': ['Long QT Syndrome']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the effect of oral GS-6615 on QTc interval in healthy adults with dofetilide-induced QTc prolongation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must, in the opinion of the investigator, be in good health based upon medical history and physical examination, including vital signs\n* Have a calculated body mass index (BMI) from 18 to 30 kg/m\\^2, inclusive, at study screening\n* Have either a normal 12-lead electrocardiogram (ECG) or one with abnormalities that are considered clinically insignificant and which do not interfere with the ability to interpret the QT interval in the opinion of the investigator in consultation with the medical monitor\n\nExclusion Criteria:\n\n* History of meningitis or encephalitis, epilepsy, seizures (known or suspected), migraines, tremors, myoclonic jerks, sleep disorder, anxiety, syncope, head injuries, or a family history of seizures\n* Have any serious or active medical or psychiatric illness (including depression) which, in the opinion of the investigator, would interfere with treatment, assessment, or compliance with the protocol. This would include renal, cardiac, hematological, hepatic, pulmonary (including chronic asthma), endocrine (including diabetes), central nervous, gastrointestinal (including an ulcer), vascular, metabolic (thyroid disorders, adrenal disease), immunodeficiency disorders, active infection, or malignancy that are clinically significant or requiring treatment.\n* Presence or history of cardiovascular disease, including structural heart disease, myocardial infarction (by ECG and/or clinical history), history of ventricular tachycardia or torsade de pointes, heart failure or cardiomyopathy (by clinical history and/or left ventricular ejection fraction \\< 40%), presence of cardiac conduction abnormalities, a family history of Long QT or Brugada Syndrome, or unexplained death in an otherwise healthy individual between the ages of 1 and 30 years\n* Additional cardiovascular-specific exclusion criteria include findings on screening ECG of:\n\n * QTcF interval \\> 430 msec\n * PR interval \\> 220 msec\n * QRS duration \\> 110 msec\n * Second- or third-degree atrioventricular block\n * Complete left or right bundle branch block or incomplete right bundle branch block\n * Resting heart rate \\< 40 or \\> 100 beats per minute (bpm)\n * Pathological Q waves (defined as Q wave \\> 40 msec)\n * Ventricular pre-excitation\n * More than 2 ectopic beats\n* Syncope, palpitations, or unexplained dizziness'}, 'identificationModule': {'nctId': 'NCT02365532', 'briefTitle': 'Effect of Oral GS-6615 on Dofetilide-Induced QT Prolongation, Safety, and Tolerability in Healthy Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Oral GS-6615 on Dofetilide-Induced QT Prolongation, Safety, and Tolerability in Healthy Subjects', 'orgStudyIdInfo': {'id': 'GS-US-372-1666'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo to match GS-6615', 'description': 'Placebo to match GS-6615 + dofetilide or placebo to match dofetilide twice daily', 'interventionNames': ['Drug: Placebo to match GS-6615', 'Drug: Placebo to match dofetilide', 'Drug: Dofetilide']}, {'type': 'EXPERIMENTAL', 'label': 'GS-6615', 'description': 'GS-6615 or placebo to match GS-6615 + dofetilide or placebo to match dofetilide twice daily', 'interventionNames': ['Drug: GS-6615', 'Drug: Placebo to match GS-6615', 'Drug: Placebo to match dofetilide', 'Drug: Dofetilide']}], 'interventions': [{'name': 'GS-6615', 'type': 'DRUG', 'description': 'GS-6615 tablets administered orally', 'armGroupLabels': ['GS-6615']}, {'name': 'Placebo to match GS-6615', 'type': 'DRUG', 'description': 'Placebo to match GS-6615 tablets administered orally', 'armGroupLabels': ['GS-6615', 'Placebo to match GS-6615']}, {'name': 'Placebo to match dofetilide', 'type': 'DRUG', 'description': 'Placebo to match dofetilide capsules administered orally', 'armGroupLabels': ['GS-6615', 'Placebo to match GS-6615']}, {'name': 'Dofetilide', 'type': 'DRUG', 'description': 'Dofetilide 500 μg capsules administered orally according to the current prescribing information', 'armGroupLabels': ['GS-6615', 'Placebo to match GS-6615']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53095', 'city': 'West Bend', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Spaulding Clinical Research, LLC', 'geoPoint': {'lat': 43.42528, 'lon': -88.18343}}], 'overallOfficials': [{'name': 'Kimberly B Patel, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gilead Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}