Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:56 PM
Study NCT ID:
NCT05824858
Status:
COMPLETED
Last Update Posted:
2023-09-29
First Post:
2023-04-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of the Effect of Food on LY3537982 in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-06-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-28', 'studyFirstSubmitDate': '2023-04-11', 'studyFirstSubmitQcDate': '2023-04-11', 'lastUpdatePostDateStruct': {'date': '2023-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC[0-inf])', 'timeFrame': 'Day 1 and Day 4 of each study period', 'description': 'PK: AUC(0-inf)'}, {'measure': 'PK: Maximum Observed Concentration (Cmax) of LY3537982', 'timeFrame': 'Day 1 and Day 4 of each study period', 'description': 'PK: Cmax of LY3537982'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to conduct blood tests to measure how much LY3537982 is in the bloodstream and how the body handles and eliminates LY3537982 after meals and on an empty stomach. The study will also evaluate the safety and tolerability of LY3537982. Participants will stay in the research center during the study, which will last about one week, not including screening.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy status as defined by the absence of evidence of any clinically significant active or chronic disease\n* Body mass index (BMI): 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive\n\nExclusion Criteria:\n\n* Females who are lactating or of childbearing potential\n* Clinically significant history of any drug sensitivity, drug allergy, or food allergy'}, 'identificationModule': {'nctId': 'NCT05824858', 'briefTitle': 'A Study of the Effect of Food on LY3537982 in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 1 Study to Evaluate the Effect of Food on the LY3537982 Pharmacokinetics in Health Adult Subjects', 'orgStudyIdInfo': {'id': 'LOXO-RAS-23006'}, 'secondaryIdInfos': [{'id': 'J3M-OX-JZQI', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY3537982 (High-Fat Meal)', 'description': 'LY3537982 administered orally under fasting conditions in one study period and under fed conditions (i.e., a standard high-fat meal) in the other study period.', 'interventionNames': ['Drug: LY3537982']}, {'type': 'EXPERIMENTAL', 'label': 'LY3537982 (Low-Fat Meal)', 'description': 'LY3537982 administered orally under fasting conditions in one study period and under fed conditions (i.e., a standard low-fat meal) in the other study period.', 'interventionNames': ['Drug: LY3537982']}], 'interventions': [{'name': 'LY3537982', 'type': 'DRUG', 'description': 'Administered orally.', 'armGroupLabels': ['LY3537982 (High-Fat Meal)', 'LY3537982 (Low-Fat Meal)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84124', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'ICON', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Yingying Guo-Avrutin, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Loxo Oncology, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Loxo Oncology, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}