Ignite Creation Date:
2025-12-24 @ 12:24 PM
Ignite Modification Date:
2026-02-02 @ 1:28 AM
Study NCT ID:
NCT02616861
Status:
COMPLETED
Last Update Posted:
2019-04-03
First Post:
2015-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of IW-1973 (A Stimulator of Soluble Guanylate Cyclase (sGC)) in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000631485', 'term': 'praliciguat'}]}}, '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': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-01', 'studyFirstSubmitDate': '2015-10-29', 'studyFirstSubmitQcDate': '2015-11-27', 'lastUpdatePostDateStruct': {'date': '2019-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment Emergent Adverse Events', 'timeFrame': '42 Days'}, {'measure': 'Maximum observed plasma concentration (Cmax)', 'timeFrame': '42 Days'}, {'measure': 'Blood Pressure', 'timeFrame': '42 days'}, {'measure': 'Area under the plasma concentration time curve during a dosing interval (AUC)', 'timeFrame': '42 Days'}, {'measure': 'Time of maximum observed plasma concentration (Tmax)', 'timeFrame': '42 Days'}, {'measure': 'Heart rate', 'timeFrame': '42 Days'}, {'measure': 'Serum cGMP', 'timeFrame': '42 Days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Stage 1: To assess the safety, tolerability, pharmacokinetic (PK) profile, and pharmacodynamic (PD) effects of the IW-1973 Tablet administered orally to healthy volunteers, in fed and fasted states, in a single-dose crossover study.\n\nStage 2: To assess the safety, tolerability, PK profile, and PD effects of a range of doses of IW-1973 Tablet administered orally to healthy subjects in a 21-day, multiple ascending-dose study with optional up-titration of dose level within cohort.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject is an ambulatory male or female between 18 and 55 years old at the Screening Visit\n* Subject's body mass index score is \\> 18.5 and \\< 30.0 kg/m2 at the Screening Visit\n* Women of childbearing potential must have a negative pregnancy test and must agree to use double-barrier contraception\n* Subject is in good health and has no clinically significant findings on a physical examination\n* Other inclusion criteria per protocol\n\nExclusion Criteria:\n\n* History of any clinically significant medical condition\n* Other exclusion criteria per protocol"}, 'identificationModule': {'nctId': 'NCT02616861', 'briefTitle': 'Trial of IW-1973 (A Stimulator of Soluble Guanylate Cyclase (sGC)) in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cyclerion Therapeutics'}, 'officialTitle': 'A 2-stage Phase 1 Study of Safety, Tolerability, PK, and PD of IW-1973 Tablet in Healthy Volunteers in an Open-label, Single-dose Stage, and a Randomized, Double Blind, Placebo-controlled, Multiple-ascending-dose Stage', 'orgStudyIdInfo': {'id': 'ICP-1973-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IW-1973', 'description': '1973 Escalating Doses', 'interventionNames': ['Drug: IW-1973']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching Placebo', 'interventionNames': ['Drug: Matching Placebo Tablet']}], 'interventions': [{'name': 'IW-1973', 'type': 'DRUG', 'description': 'IW-1973 Tablet', 'armGroupLabels': ['IW-1973']}, {'name': 'Matching Placebo Tablet', 'type': 'DRUG', 'description': 'Matching placebo tablet', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78209', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Ironwood Investigator', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'John Hanrahan, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ironwood Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cyclerion Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}