Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-27 @ 11:26 PM
Study NCT ID:
NCT05860933
Status:
COMPLETED
Last Update Posted:
2024-11-08
First Post:
2023-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of the Effects of Itraconazole or Carbamazepine on LY3537982 in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017964', 'term': 'Itraconazole'}, {'id': 'D002220', 'term': 'Carbamazepine'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D003984', 'term': 'Dibenzazepines'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2023-08-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-07', 'studyFirstSubmitDate': '2023-05-08', 'studyFirstSubmitQcDate': '2023-05-08', 'lastUpdatePostDateStruct': {'date': '2024-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3537982 administered with or without itraconazole', 'timeFrame': 'Predose on day 1 up to 72 hours postdose on day 9', 'description': 'PK: Cmax of LY3537982 administered with or without itraconazole'}, {'measure': 'PK: Area Under the Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC[0-inf]) of LY3537982 administered with or without itraconazole', 'timeFrame': 'Predose on day 1 up to 72 hours postdose on day 9', 'description': 'PK: AUC\\[0-inf\\] of LY3537982 administered with or without itraconazole'}, {'measure': 'PK: AUC from Time 0 to time of the last measurable concentration (AUClast) of LY3537982 administered with or without itraconazole', 'timeFrame': 'Predose on day 1 up to 72 hours postdose on day 9', 'description': 'PK: AUClast of LY3537982 administered with or without itraconazole'}, {'measure': 'PK: Cmax of LY3537982 administered with or without carbamazepine', 'timeFrame': 'Predose on day 1 up to 72 hours postdose on day 13', 'description': 'PK: Cmax of LY3537982 administered with or without carbamazepine'}, {'measure': 'PK: AUC[0-inf] of LY3537982 administered with or without carbamazepine', 'timeFrame': 'Predose on day 1 up to 72 hours postdose on day 13', 'description': 'PK: AUC\\[0-inf\\] of LY3537982 administered with or without carbamazepine'}, {'measure': 'PK: AUClast of LY3537982 administered with or without carbamazepine', 'timeFrame': 'Predose on day 1 up to 72 hours postdose on day 13', 'description': 'PK: AUClast of LY3537982 administered with or without carbamazepine'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate the effect of itraconazole and carbamazepine on LY3537982 when administered as multiple doses by conducting the blood tests to measure how much LY3537982 is in the bloodstream and how the body handles and eliminates LY3537982 in adult healthy participants. The study will also evaluate the safety and tolerability of LY3537982. The study is conducted in two parts. Participants will stay in the research center during the study, which will last about 11 and 15 days for part 1 and part 2, respectively, 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': 'NCT05860933', 'briefTitle': 'A Study of the Effects of Itraconazole or Carbamazepine on LY3537982 in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 1 Study to Evaluate the Effects of Multiple Doses of Itraconazole or Carbamazepine on the Single-Dose Pharmacokinetics of LY3537982 in Healthy Adult Subjects', 'orgStudyIdInfo': {'id': 'LOXO-RAS-22002'}, 'secondaryIdInfos': [{'id': 'J3M-OX-JZQD', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY3537982 + Itraconazole (Part 1)', 'description': 'LY3537982 administered orally alone followed by LY3537982 administered in combination with itraconazole orally.', 'interventionNames': ['Drug: LY3537982', 'Drug: Itraconazole']}, {'type': 'EXPERIMENTAL', 'label': 'LY3537982 + Carbamazepine (Part 2)', 'description': 'LY3537982 administered orally alone followed by LY3537982 administered in combination with carbamazepine orally.', 'interventionNames': ['Drug: LY3537982', 'Drug: Carbamazepine']}], 'interventions': [{'name': 'LY3537982', 'type': 'DRUG', 'otherNames': ['Olomorasib'], 'description': 'Administered orally.', 'armGroupLabels': ['LY3537982 + Carbamazepine (Part 2)', 'LY3537982 + Itraconazole (Part 1)']}, {'name': 'Itraconazole', 'type': 'DRUG', 'description': 'Administered orally.', 'armGroupLabels': ['LY3537982 + Itraconazole (Part 1)']}, {'name': 'Carbamazepine', 'type': 'DRUG', 'description': 'Administered orally.', 'armGroupLabels': ['LY3537982 + Carbamazepine (Part 2)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78209', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'ICON Early Development Services', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84124', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'ICON Early Development Services', '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'}}}}