Ignite Creation Date:
2025-12-24 @ 4:23 PM
Ignite Modification Date:
2026-01-05 @ 3:05 AM
Study NCT ID:
NCT04783766
Status:
COMPLETED
Last Update Posted:
2025-01-24
First Post:
2021-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability and Pharmacokinetics Study of CK-3773274
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002312', 'term': 'Cardiomyopathy, Hypertrophic'}], 'ancestors': [{'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001020', 'term': 'Aortic Stenosis, Subvalvular'}, {'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2021-08-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-22', 'studyFirstSubmitDate': '2021-03-03', 'studyFirstSubmitQcDate': '2021-03-04', 'lastUpdatePostDateStruct': {'date': '2025-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subject incidence of Adverse Event (AE), Serious Adverse Event (SAE)', 'timeFrame': 'SAD cohorts: Day-1 - Day10; MD cohort: Day-1 - Day 23'}, {'measure': 'Reduced Left Ventricular Ejection Fraction (LVEF)', 'timeFrame': 'SAD cohorts: Day-1 - Day10; MD cohort: Day-1 - Day 23'}], 'secondaryOutcomes': [{'measure': 'Cmax of CK-3773274 after single and multiple ascending doses', 'timeFrame': 'SAD Cohorts: Day-1 - Day10; MD Cohort: Day-1 - Day 23'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CK-274', 'Obstructive hypertrophic cardiomyopathy', 'CK-3773274', 'oHCM', 'aficamten'], 'conditions': ['Obstructive Hypertrophic Cardiomyopathy', 'Healthy Adult Subjects']}, 'referencesModule': {'references': [{'pmid': '37680714', 'type': 'DERIVED', 'citation': 'Zhao X, Liu H, Tian W, Fang L, Yu M, Wu X, Liu A, Wan R, Li L, Luo J, Li Y, Liu B, He Y, Chen X, Li Y, Xu D, Wang H, Han X. Safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of aficamten in healthy Chinese participants: a randomized, double-blind, placebo-controlled, phase 1 study. Front Pharmacol. 2023 Aug 23;14:1227470. doi: 10.3389/fphar.2023.1227470. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': 'The purposes of this study are to:\n\n1. Learn about the safety of CK-3773274 after a single dose and multiple doses in Chinese healthy adult subjects.\n2. Learn how healthy subjects tolerate CK-3773274 after a single dose and multiple doses.\n3. Find out how much CK-3773274 is in the blood after a single dose and multiple doses.\n4. Determine the effect of doses of CK-3773274 on the pumping function of the heart.\n5. Evaluate the effect CYP2D6 genetic polymorphisms on how the body metabolizes CK-3773274.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy Chinese males and females between 18 and 45 years of age, inclusive\n2. Body weight ≥50kg and body mass index (BMI) within 18 to 26 kg/m2, inclusive\n3. Acoustic windows adequate for accurate transthoracic echocardiograms\n4. Normal cardiac structure and function, as determined by the cardiologist, or if abnormalities are present, the finding is not clinically significant as determined by the cardiologist\n5. LVEF ≥65 percent at screening, and LVEF ≥60 percent at Day-1\n6. Normal ECG\n\nExclusion Criteria:\n\n1. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs\n2. Subjects with breast implants that may impede echocardiography\n3. A clinically significant illness within 4 weeks prior to admission to the CRU\n4. Inability to swallow tablets\n5. Use of alcohol-containing, grapefruit-containing, or caffeine-containing foods or beverages within 48 hours prior to admission to the CRU\n6. Poor peripheral venous access\n7. Any blood donation within 60 days prior to admission to the CRU, or any plasma donation within 30 days prior to admission to the CRU, or receipt of blood products within 2 months prior to admission to the CRU'}, 'identificationModule': {'nctId': 'NCT04783766', 'briefTitle': 'Safety, Tolerability and Pharmacokinetics Study of CK-3773274', 'organization': {'class': 'INDUSTRY', 'fullName': 'Corxel Pharmaceuticals'}, 'officialTitle': 'A Phase 1, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of CK-3773274 in Healthy Chinese Subjects', 'orgStudyIdInfo': {'id': 'JX01001'}, 'secondaryIdInfos': [{'id': 'CTR20210291', 'type': 'OTHER', 'domain': 'China CDE clinical trial registration'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CK-3773274 for Single Ascending Dose (SAD) Cohorts', 'description': 'Subjects will be assigned to one of 2 planned dose cohorts and receive single doses of CK-3773274', 'interventionNames': ['Drug: CK-3773274']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo comparator for SAD Cohorts', 'description': 'Subjects will be assigned to one of 2 planned dose cohorts and receive single doses of placebo comparator', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'CK-3773274 for Multiple Dose (MD) Cohort', 'description': 'Subjects will receive multiple doses of CK-3773274', 'interventionNames': ['Drug: CK-3773274']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo comparator for MD Cohort', 'description': 'Subjects will receive multiple doses of placebo comparator', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'CK-3773274', 'type': 'DRUG', 'description': 'CK-3773274- Tablets', 'armGroupLabels': ['CK-3773274 for Multiple Dose (MD) Cohort', 'CK-3773274 for Single Ascending Dose (SAD) Cohorts']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo- Tablets', 'armGroupLabels': ['Placebo comparator for MD Cohort', 'Placebo comparator for SAD Cohorts']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100032', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Clinical Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Chen, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Corxel Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corxel Pharmaceuticals', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Cytokinetics', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}