Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-26 @ 1:41 AM
Study NCT ID:
NCT03426033
Status:
COMPLETED
Last Update Posted:
2018-04-05
First Post:
2018-01-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Drug-drug Interaction Study to Evaluate the Effect of ISIS 681257 on Warfarin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014859', 'term': 'Warfarin'}], 'ancestors': [{'id': 'D015110', 'term': '4-Hydroxycoumarins'}, {'id': 'D003374', 'term': 'Coumarins'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-02-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-03', 'studyFirstSubmitDate': '2018-01-03', 'studyFirstSubmitQcDate': '2018-02-06', 'lastUpdatePostDateStruct': {'date': '2018-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The plasma concentrations of warfarin and ISIS 681257 will be measured at each individual time point.', 'timeFrame': 'Each day for days 1-10 and 15-45', 'description': 'To evaluate the effect of multiple doses of ISIS 681257 40 mg subcutaneous injections on the pharmacokinetics of a single oral dose of warfarin in healthy adult subjects.'}], 'secondaryOutcomes': [{'measure': 'The safety of ISIS 681257 by the incidence of treatment-emergent adverse events.', 'timeFrame': '45 days', 'description': 'To evaluate the safety and tolerability of multiple doses of ISIS 681257 40 mg subcutaneous injections when coadministered with a single oral dose of warfarin in healthy adult subjects.'}, {'measure': 'Prothrombin Time will be measured by testing blood samples at each individual time point.', 'timeFrame': 'Each day for days 1-7 and 15-21', 'description': 'To evaluate the effect of multiple doses of ISIS 681257 40 mg subcutaneous injections on the pharmacodynamics (anticoagulant activity) of a single oral dose of warfarin in healthy adult subjects.'}, {'measure': 'International normalized ratio will be measured at each individual time point by comparing prothrombin time to the normal mean prothrombin time.', 'timeFrame': 'Each day for days 1-7 and 15-21', 'description': 'To evaluate the effect of multiple doses of ISIS 681257 40 mg subcutaneous injections on the pharmacodynamics (anticoagulant activity) of a single oral dose of warfarin in healthy adult subjects.'}, {'measure': 'Activated partial thromboplastin time will be measured by testing blood samples at each individual time point.', 'timeFrame': 'Each day for days 1-7 and 15-21', 'description': 'To evaluate the effect of multiple doses of ISIS 681257 40 mg subcutaneous injections on the pharmacodynamics (anticoagulant activity) of a single oral dose of warfarin in healthy adult subjects.'}, {'measure': 'The plasma concentrations of warfarin and ISIS 681257 will be measured at each individual time point.', 'timeFrame': 'Each day for days 1-10 and 15-45', 'description': 'To evaluate the effect of a single dose of warfarin on the pharmacokinetics of a single subcutaneous 40 mg injection of ISIS 681257 in healthy adult subjects.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Elevated Lipoprotein(a)', 'Cardiovascular Diseases']}, 'referencesModule': {'references': [{'pmid': '37070852', 'type': 'DERIVED', 'citation': 'Milosavljevic MN, Stefanovic SM, Pejcic AV. Potential Novel RNA-Targeting Agents for Effective Lipoprotein(a) Lowering: A Systematic Assessment of the Evidence From Completed and Ongoing Developmental Clinical Trials. J Cardiovasc Pharmacol. 2023 Jul 1;82(1):1-12. doi: 10.1097/FJC.0000000000001429.'}]}, 'descriptionModule': {'briefSummary': 'This is a single center, open label, single sequence, two-treatment, two-period drug-drug interaction study to evaluate the effect of multiple doses of ISIS 681257 on the pharmacokinetics of a single dose of warfarin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Motivated and available for duration of study and willing to adhere to protocol\n* Males who are unable to procreate or agree to contraception throughout study\n* Females who are postmenopausal or surgically sterile\n* BMI between 18.5 and 30 kg/m2\n* Weighing greater than or equal to 50kg\n* Normal lab results\n* No known diseases or significant findings on physical exam\n\nExclusion Criteria:\n\n* Females of childbearing potential\n* Reactions/infection at injection site\n* Hypersensitivity to any drugs or similar drugs to those used in the study\n* Conditions or disease that may interfere with study drug\n* Any significant diseases\n* Known history or familial history of bleeding disorders\n* Drug dependency or abuse\n* Illness within 28 days\n* Previous exposure to other investigational drug within 28 days\n* Blood donations within 28 days'}, 'identificationModule': {'nctId': 'NCT03426033', 'briefTitle': 'Drug-drug Interaction Study to Evaluate the Effect of ISIS 681257 on Warfarin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Akcea Therapeutics'}, 'officialTitle': 'Phase 1, Drug-Drug Interaction Study To Evaluate The Effect Of Multiple Doses Of ISIS 681257 40 mg Subcutaneous Injections On The Pharmacokinetics And Pharmacodynamics Of Warfarin In Healthy Subjects', 'orgStudyIdInfo': {'id': 'ISIS 681257-CS10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single dose of warfarin', 'description': 'Single dose of warfarin administered to obtain pharmacokinetic information.', 'interventionNames': ['Drug: Warfarin']}, {'type': 'EXPERIMENTAL', 'label': 'Warfarin in combination with ISIS 681257', 'description': 'ISIS 681257 administered and pharmacokinetic assessments are taken. Then ISIS 681257 is administered with warfarin and additional pharmacokinetic information is obtained.', 'interventionNames': ['Drug: ISIS 681257', 'Drug: Warfarin']}], 'interventions': [{'name': 'ISIS 681257', 'type': 'DRUG', 'description': 'Xmg dose administered as a subcutaneous injection', 'armGroupLabels': ['Warfarin in combination with ISIS 681257']}, {'name': 'Warfarin', 'type': 'DRUG', 'description': '25mg tablet administered orally', 'armGroupLabels': ['Single dose of warfarin', 'Warfarin in combination with ISIS 681257']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3P 3H5', 'city': 'Mount Royal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Clinical Site', 'geoPoint': {'lat': 45.51675, 'lon': -73.64918}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Akcea Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}