Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 9:05 PM
Study NCT ID:
NCT07439250
Status:
RECRUITING
Last Update Posted:
2026-03-23
First Post:
2026-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Olomorasib (LY3537982) in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015725', 'term': 'Fluconazole'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-19', 'studyFirstSubmitDate': '2026-02-24', 'studyFirstSubmitQcDate': '2026-02-24', 'lastUpdatePostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Olomorasib', 'timeFrame': 'Baseline, Day 12', 'description': 'PK: Area Under the Concentration Versus Time Curve (AUC) of olomorasib'}, {'measure': 'Pharmacokinetics (PK): Maximum Concentration (Cmax) of Olomorasib', 'timeFrame': 'Baseline, Day 12', 'description': 'PK: Cmax of Olomorasib'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study in healthy participants is to determine the effect of fluconazole on the amount of study drug that gets into the bloodstream and how long it takes the body to get rid of it. For each participant, the study will last up to approximately 7 weeks and will require 12 overnight stays in the research center.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.\n* Must have a Body Mass Index (BMI) within the range of 18.0 to 30.0 kilograms per square meter (kg/m2)\n* Participants assigned male at birth (AMAB) or participants assigned female at birth (AFAB) who are individuals not of childbearing potential (INOCBP).\n\nExclusion Criteria:\n\n* History or presence of the following conditions:\n\n * metabolic disease\n * biliary disease\n * gastrointestinal disease\n * hematological disease\n * neurological disease\n * significant history of hepatic disease\n * clinically significant, active cardiovascular disease or history of myocardial infarction within 6 months prior to Day 1\n* Abnormal blood pressure or pulse rate\n* Have a 12-lead electrocardiogram (ECG) abnormality, in the opinion of the investigator, increases the risks associated with participating in the study, or may confound ECG analysis\n* History of malignancy within 5 years prior to screening, except for basal cell or squamous epithelial carcinomas of the skin or in situ carcinoma of the cervix, that have been resected with no evidence of metastatic disease for 3 years.\n* Show evidence of Human Immunodeficiency Virus (HIV) infection or positive HIV antibodies\n* Have a positive hepatitis C antibody test\n* Have evidence of hepatitis B at screening, that is, positive test for hepatitis B surface antigen, Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA), or both.\n* Have alcohol intake that exceeds recommended average weekly alcohol consumption limits per local regulation\n* Use of tobacco, smoking-cessation products, electronic (e)-cigarettes (nicotine and non-nicotine), or nicotine products within 90 days prior to first olomorasib administration and through the end of trial'}, 'identificationModule': {'nctId': 'NCT07439250', 'briefTitle': 'A Study of Olomorasib (LY3537982) in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 1, Open-Label, Fixed-Sequence Study to Investigate the Effect of Fluconazole on the Pharmacokinetics of Olomorasib (LY3537982) in Healthy Participants', 'orgStudyIdInfo': {'id': '27768'}, 'secondaryIdInfos': [{'id': 'J3M-MC-JZQM', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Olomorasib + Fluconazole', 'description': 'Administered orally', 'interventionNames': ['Drug: Olomorasib', 'Drug: Fluconazole']}, {'type': 'OTHER', 'label': 'Olomorasib', 'description': 'Administered orally', 'interventionNames': ['Drug: Olomorasib']}], 'interventions': [{'name': 'Olomorasib', 'type': 'DRUG', 'otherNames': ['LY3537982'], 'description': 'Administered orally', 'armGroupLabels': ['Olomorasib', 'Olomorasib + Fluconazole']}, {'name': 'Fluconazole', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Olomorasib + Fluconazole']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32117-5116', 'city': 'Daytona Beach', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Fortrea Clinical Research Unit - Daytona Beach', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}], 'centralContacts': [{'name': 'There may be multiple sites in this clinical trial. (Add "This 1-877-CTLILLY (1-877-285-4559) or', 'role': 'CONTACT', 'email': 'clinical_inquiry_hub@lilly.com', 'phone': '1-317-615-4559'}], 'overallOfficials': [{'name': 'Contact Lilly at 1-877-CTLILLY (1-877-285-4559) or', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}