Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2025-12-29 @ 2:45 AM
Study NCT ID:
NCT07247357
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of LY4064809 in Healthy Adult Chinese Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-10-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2025-11-18', 'studyFirstSubmitQcDate': '2025-11-18', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4064809', 'timeFrame': 'Predose on Day 1 Through Day 14', 'description': 'PK: Cmax of LY4064809'}, {'measure': 'PK: Area Under the Concentration Versus Time Curve (AUC) of LY4064809', 'timeFrame': 'Predose on Day 1 Through Day 14', 'description': 'PK: AUC of LY4064809'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to measure how much LY4064809 gets into the bloodstream and how long it takes the body to eliminate it in healthy participants. It also looks at safety and tolerability in healthy participants. The study drug will be administered orally. The study will last approximately 21 days, excluding screening.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Are native Chinese. To qualify as a native Chinese for the purpose of this study, all 4 of the participant's biological grandparents must be of exclusive Chinese descent and born in China\n* Are overtly healthy as determined by medical evaluation, including medical history, physical examination, vital signs, and electrocardiogram (ECG) at screening and admission\n* Have clinical laboratory test results within the normal range for the population or investigative site, or with abnormalities deemed not clinically significant by the investigator at screening\n* Have a body mass index within the range 18 to 32 kilogram per square meter (kg/m²)\n\nExclusion Criteria:\n\n* History or presence of any of the following conditions, deemed clinically significant by the investigator (or designee), which may significantly alter the absorption, metabolism, or elimination of drugs, constitute a risk when taking the study intervention, or interfere with the data interpretation:\n\n * metabolic disease, including congenital non-hemolytic hyperbilirubinemia, for example, Gilbert syndrome\n * bile duct disease, including removal of the gall bladder\n * digestive system disease\n * blood disease\n * disease of the nervous system\n * significant history of, or presence of, liver disease, including any abnormal liver function tests, as defined by aspartate aminotransferase, alanine transaminase, or transducin beta-like above the 1.5× upper limit of normal range per the laboratory's reference ranges at screening, or\n * clinically significant, active cardiovascular disease or history of heart attack within 6 months prior to the planned start of LY4064809\n* Have a 12-lead ECG abnormality at screening or admission\n* History of a major surgical procedure within 30 days prior to screening\n* Diagnosed or treated cancer within 5 years prior to screening\n* Have known allergies to LY4064809 or related compounds"}, 'identificationModule': {'nctId': 'NCT07247357', 'briefTitle': 'A Study of LY4064809 in Healthy Adult Chinese Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 1, Open-Label Study of the Pharmacokinetics of LY4064809 in Healthy Adult Chinese Participants', 'orgStudyIdInfo': {'id': '27745'}, 'secondaryIdInfos': [{'id': 'J6M-MC-JSGE', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY4064809', 'description': 'LY4064809 administered orally', 'interventionNames': ['Drug: LY4064809']}], 'interventions': [{'name': 'LY4064809', 'type': 'DRUG', 'description': 'administered orally', 'armGroupLabels': ['LY4064809']}]}, 'contactsLocationsModule': {'locations': [{'zip': '138623', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Lilly Centre for Clinical Pharmacology', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], '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'}, 'collaborators': [{'name': 'Scorpion Therapeutics, a wholly owned subsidiary of Eli Lilly and Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}