Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2026-01-01 @ 8:53 PM
Study NCT ID:
NCT04240158
Status:
TERMINATED
Last Update Posted:
2024-08-16
First Post:
2020-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IW-6463 Safety Study in Healthy Elderly Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'whyStopped': 'Some subjects could not complete the second crossover period due to COVID-19-related site closure. The study was closed to allow analysis of all collected data.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2020-05-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-13', 'studyFirstSubmitDate': '2020-01-21', 'studyFirstSubmitQcDate': '2020-01-21', 'lastUpdatePostDateStruct': {'date': '2024-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Cerebral Blood Flow (CBF) at Day 15', 'timeFrame': 'Baseline, 15 days', 'description': 'Change from baseline in CBF as measured by magnetic resonance imaging (MRI) and arterial spin labeling (ASL) after administration of IW-6463 vs. placebo'}, {'measure': 'Number of Participants With ≥1 Treatment-Emergent Adverse Events (TEAEs)', 'timeFrame': 'Up to 42 days'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Other']}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-blind, placebo-controlled, 2-way cross-over study in healthy male and female elderly participants.', 'detailedDescription': 'Participants will receive up to a total of 30 daily doses of study drug (15 days of daily IW-6463, only; 15 days of daily placebo, only) administered across two 15-day dosing periods (Period 1 and Period 2). The dosing periods will be separated by a 27-day washout. Participants will be randomized to a sequence of receiving IW-6463 for Period 1 and then placebo for Period 2, or vice versa.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is an ambulatory adult at least 65 years old at the screening visit\n* Subject is in good health and has no clinically significant findings on physical examination\n* Female participants must be postmenopausal. A postmenopausal state is defined as no menses for ≥12 consecutive months without an alternative medical cause. A high follicle-stimulating hormone (FSH) level at screening (\\>40 IU/L or mIU/mL) in the postmenopausal range may be used to confirm a postmenopausal state.\n* Male participants who have not been surgically sterilized by vasectomy (conducted ≥60 days before the Screening Visit or confirmed via sperm analysis) must agree contraceptive use per protocol\n* Men must also agree to not donate sperm throughout the study and for 3 months after the final dose of study drug\n* Other inclusion criteria per protocol\n\nExclusion Criteria:\n\n* Any active or unstable clinically significant medical condition\n* Other exclusion criteria per protocol'}, 'identificationModule': {'nctId': 'NCT04240158', 'briefTitle': 'IW-6463 Safety Study in Healthy Elderly Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tisento Therapeutics'}, 'officialTitle': 'Evaluating the Safety, Tolerability, and Pharmacodynamic Properties of IW-6463 in Healthy Elderly Subjects', 'orgStudyIdInfo': {'id': 'C6463-102'}, 'secondaryIdInfos': [{'id': 'CY6463', 'type': 'OTHER', 'domain': 'Cyclerion Therapeutics'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IW-6463', 'description': 'IW-6463 tablets administered orally', 'interventionNames': ['Drug: IW-6463']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching placebo tablets administered orally', 'interventionNames': ['Drug: Matching Placebo']}], 'interventions': [{'name': 'IW-6463', 'type': 'DRUG', 'otherNames': ['CY6463', 'zagociguat'], 'description': 'IW-6463 Tablet', 'armGroupLabels': ['IW-6463']}, {'name': 'Matching Placebo', 'type': 'DRUG', 'description': 'Matching Placebo Tablet', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Centre for Human Drug Research (CHDR)', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}], 'overallOfficials': [{'name': 'Chad Glasser, PharmD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cyclerion Therapeutics, Inc'}, {'name': 'Geert Jan Groeneveld, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre for Human Drug Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tisento Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}