Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2025-12-30 @ 4:31 PM
Study NCT ID:
NCT06594159
Status:
COMPLETED
Last Update Posted:
2025-04-03
First Post:
2024-09-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of LY4065967 in Healthy Japanese Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Part A and B-Double-blinded Part A3 and D-Open-label'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-31', 'studyFirstSubmitDate': '2024-09-10', 'studyFirstSubmitQcDate': '2024-09-10', 'lastUpdatePostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part A: Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered to be Related to Study Drug Administration', 'timeFrame': 'Baseline to 7 Days', 'description': 'Part A: A summary of TEAEs and SAEs regardless of causality, will be reported in the Reported Adverse Events module'}, {'measure': 'Part B: Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered to be Related to Study Drug Administration', 'timeFrame': 'Baseline to 12 Days', 'description': 'Part B: A summary of TEAEs and SAEs regardless of causality, will be reported in the Reported Adverse Events module'}, {'measure': 'Part D: PK: Maximum Concentration (Cmax) of Rosuvastatin', 'timeFrame': 'Predose on Day 1 Through 72 Hours Post-Dose', 'description': 'Part D: PK: Cmax of Rosuvastatin'}, {'measure': 'Part D: PK: Area Under the Concentration Versus Time Curve (AUC) of Rosuvastatin', 'timeFrame': 'Predose on Day 1 Through 72 Hours Post-Dose', 'description': 'Part D: PK: AUC of Rosuvastatin'}], 'secondaryOutcomes': [{'measure': 'Part A : Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4065967', 'timeFrame': 'Predose on Day 1 Through 48 Hours Post-Dose', 'description': 'Part A: PK: Cmax of LY4065967'}, {'measure': 'Part B: PK: Cmax of LY4065967', 'timeFrame': 'Predose on Day 1 Through Day 9', 'description': 'Part B: PK: Cmax of LY4065967'}, {'measure': 'Part A and B: PK: Area Under the Concentration Versus Time Curve (AUC) of LY4065967', 'timeFrame': 'Predose on Day 1 Through 48 Hours Post-Dose', 'description': 'Part A and B: PK: AUC of LY4065967'}, {'measure': 'Part D: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4065967', 'timeFrame': 'Day 5 Through Day 11', 'description': 'Part D: PK: Cmax of LY4065967'}, {'measure': 'Part D: PK: Area Under the Concentration Versus Time Curve (AUC) of LY4065967', 'timeFrame': 'Day 5 Through Day 11', 'description': 'Part D: PK: AUC of LY4065967'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to obtain safety and tolerability data of the study drug known as LY4065967 and rosuvastatin in healthy Japanese participants. Blood tests will be performed to check how much LY4065967 and rosuvastatin get into the bloodstream and how long it takes the body to eliminate it. This is a 3-part study and will last approximately 2 weeks excluding screening period for each part.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Japanese participants who are overtly healthy as determined by medical evaluation including medical history and physical examination\n* Have a body mass index within the range 18 to 30 kilogram per square meter (kg/m2)\n* Have a body weight of:\n* ≥ 40 kilograms (kg) for individuals assigned female at birth\n* ≥ 50 kg for individuals assigned male at birth\n\nExclusion Criteria:\n\n* Have a history or presence of medical illness including, but not limited to, any cardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric or neurological disease, or convulsions that, in the judgment of the investigator, indicate a medical problem that would preclude study participation\n* Have an abnormality in the 12-lead echocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study\n* Have a history of clinically significant multiple or severe drug allergies or severe posttreatment hypersensitivity reactions, which in the opinion of the investigator may hamper participation in the study\n* Show evidence of hepatitis C and/or have a positive hepatitis C virus antibody test\n* Show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antigen and/or antibodies.\n* Show evidence of hepatitis B and/or positive hepatitis B surface antigen\n* Show evidence of syphilis or have a positive syphilis test.\n* Have an abnormal blood pressure (supine) as determined by the investigator\n* Are pregnant or intend to become pregnant or to breastfeed during the study.\n* Participants with a history of drug abuse which, in the opinion of the investigator, is clinically significant or who test positive for drugs of abuse at screening or admission\n* Have alcohol intake that exceeds recommended average weekly alcohol consumption limits per local regulation, or an amount deemed significant by the investigator\n* Smoke more than 10 cigarettes per day or the equivalent including electronic cigarettes\n* Are unwilling to comply with the dietary restrictions required for this study'}, 'identificationModule': {'nctId': 'NCT06594159', 'briefTitle': 'A Study of LY4065967 in Healthy Japanese Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 1 Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of LY4065967, to Evaluate the Effect of LY4065967 on the Pharmacokinetics of Rosuvastatin in Healthy Japanese Participants', 'orgStudyIdInfo': {'id': '18815'}, 'secondaryIdInfos': [{'id': 'J4X-JE-LWCA', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY4065967 Part A', 'description': 'A single dose of LY4065967 administered orally', 'interventionNames': ['Drug: LY4065967']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Part A', 'description': 'Placebo administered orally', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'LY4065967 Part B', 'description': 'Multiple doses of LY4065967 administered orally', 'interventionNames': ['Drug: LY4065967']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Part B', 'description': 'Placebo administered orally', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'LY4065967 and Rosuvastatin Part D', 'description': 'LY4065967 and Rosuvastatin administered orally', 'interventionNames': ['Drug: LY4065967', 'Drug: Rosuvastatin']}], 'interventions': [{'name': 'LY4065967', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['LY4065967 Part A', 'LY4065967 Part B', 'LY4065967 and Rosuvastatin Part D']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Placebo Part A', 'Placebo Part B']}, {'name': 'Rosuvastatin', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['LY4065967 and Rosuvastatin Part D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '813-0017', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Souseikai Fukuoka Mirai Hospital', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}