Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2026-01-01 @ 7:00 AM
Study NCT ID:
NCT02910635
Status:
COMPLETED
Last Update Posted:
2022-01-28
First Post:
2016-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Effect of Volanesorsen on Cardiac Repolarization Conducted in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000593612', 'term': 'ISIS 304801'}, {'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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2016-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-13', 'studyFirstSubmitDate': '2016-09-09', 'studyFirstSubmitQcDate': '2016-09-19', 'lastUpdatePostDateStruct': {'date': '2022-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Volanesorse plasma pharmacokinetics (PK)', 'timeFrame': '0 to 24 hours', 'description': 'Area under the plasma concentration time curve from time 0 to 24 hours (AUC 0-24h)'}], 'primaryOutcomes': [{'measure': "Placebo corrected change from baseline in QTcF (corrected Frederica's CT Interval)", 'timeFrame': '24 Hours', 'description': 'ECG monitoring up to 24 hours post dose'}], 'secondaryOutcomes': [{'measure': 'Placebo corrected change from baseline heart rate (HR, PR and QRS)', 'timeFrame': '24 Hours', 'description': 'ECG monitoring 24 hours post dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Thorough QTc, Therapeutic dose, supra therapeutic dose'], 'conditions': ['Abnormalities, Cardiovascular']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to assess the corrected QT interval (QTc) effect of volanesorsen (ISIS 304801) administered as a 300 mg subcutaneous (SC) therapeutic and a 300 mg intravenous (IV; 2-hour infusion) supra-therapeutic dose relative to placebo in healthy adult male and female subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must have given written informed consent and be able to comply with all study requirements\n* Males and females aged 18-55 at the time of informed consent\n* Females must be non-pregnant and non-lactating surgically sterile, post-menopausal or if engaged in sexual relations of childbearing potential, using an acceptable contraceptive method\n* Males must be surgically sterile, abstinent or using an acceptable contraceptive method\n* The subject has a BMI of 19 to 32 kg/m\\^2 inclusive\n* Consumption of nicotine or nicotine-containing products for at least 6 months before Screening\n\nExclusion Criteria:\n\n* History of risk factors for Torsades de Pointes, unexplained syncope, known Long QT Syndrome, heart failure, myocardial infarction, angina, or clinical significant abnormal laboratory assessments including hypokalemia, hypocalcemia, hypercalcemia, or hypomagnesemia\n* Abnormal screening ECG\n* Use of concomitant medications unless authorized by the Sponsor Medical Monitor\n* Known history of or positive test for human immunodeficiency virus (HIV), hepatitis C or chronic hepatitis B\n* Treatment with another Study Drug, biological agent, or device within one-month of Screening\n* Tests positive for drugs of abuse or cotinine\n* Considered unsuitable for inclusion by the Principal Investigator'}, 'identificationModule': {'nctId': 'NCT02910635', 'briefTitle': 'A Study to Evaluate the Effect of Volanesorsen on Cardiac Repolarization Conducted in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ionis Pharmaceuticals, Inc.'}, 'officialTitle': 'A Randomized, Placebo-Controlled, Four-Period Crossover, Study to Evaluate the Effect of Volanesorsen on the QTc Interval Using a Therapeutic and Supra-Therapeutic Dose Compared With Placebo in Healthy Volunteers: a Thorough QT Study', 'orgStudyIdInfo': {'id': 'ISIS 304801-CS13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Volanesorsen, Intravenous (IV)', 'description': '300 mg of volanesorsen (ISIS 304801) administered Intravenous (IV) single dose', 'interventionNames': ['Drug: Volanesorsen']}, {'type': 'EXPERIMENTAL', 'label': 'Volanesorsen, Subcutaneous (SQ)', 'description': '300 mg of volanesorsen (ISIS 304801) administered Subcutaneous (SQ) single dose', 'interventionNames': ['Drug: Volanesorsen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Moxifloxacin Hydrochloride', 'description': 'Moxifloxacin Hydrochloride 400 mg tablet administered orally, Single Dose', 'interventionNames': ['Drug: Moxifloxacin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Intravenous (IV) single dose', 'description': 'Administered as normal saline (0.9% Sodium Chloride)', 'interventionNames': ['Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Subcutaneous (SC) single dose', 'description': 'Administered as normal saline (0.9% Sodium Chloride)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Volanesorsen', 'type': 'DRUG', 'description': 'ISIS 304801 is supplied as 200mg of volanesorsen with 1.0mL of solution per vial', 'armGroupLabels': ['Volanesorsen, Intravenous (IV)', 'Volanesorsen, Subcutaneous (SQ)']}, {'name': 'Moxifloxacin', 'type': 'DRUG', 'description': 'Moxifloxacin Hydrochloride 400 mg tablet administered orally, Single Dose', 'armGroupLabels': ['Moxifloxacin Hydrochloride']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo Intravenous (IV) single dose', 'Placebo Subcutaneous (SC) single dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75247', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Covance', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ionis Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Akcea Therapeutics', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}