Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-31 @ 2:31 PM
Study NCT ID:
NCT06345794
Status:
COMPLETED
Last Update Posted:
2025-04-27
First Post:
2024-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess LY4100511 (DC-853) in Healthy Adult Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017964', 'term': 'Itraconazole'}, {'id': 'D015725', 'term': 'Fluconazole'}, {'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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-22', 'studyFirstSubmitDate': '2024-03-28', 'studyFirstSubmitQcDate': '2024-03-28', 'lastUpdatePostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY4100511 (DC-853)', 'timeFrame': 'Predose up to 26 Days'}, {'measure': 'PK: PK: Area Under the Concentration Versus Time Curve From Zero to Last Measurable Concentration (AUC[0-t]) of LY4100511 (DC-853)', 'timeFrame': 'Predose up to 26 Days'}, {'measure': 'PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of LY4100511 (DC-853)', 'timeFrame': 'Predose up to 26 Days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['DC-853', 'LY4100511'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to assess the effect of multiple doses of itraconazole, fluconazole, and carbamazepine on single dose pharmacokinetic of LY4100511 (DICE-853) in healthy participants. The study will also evaluate the safety and tolerability of LY4100511 (DICE-853) with itraconazole, fluconazole, and carbamazepine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a body mass index within the range of 18.0 to 32 kilograms per square meter (kg/m²)\n* Males who agree to follow contraceptive requirements and women of not childbearing potential\n* Have body weight greater than or equal to (\\>=) 50 Kilograms at screening.\n* Must have a negative Interferon-Gamma Release Assays (IGRA) testing at screening\n* Must have been stopped all the prescribed medication at least 14 days prior to admission to the clinical site\n* Ability and willingness to abstain from alcohol, caffeine, and methylxanthine-containing beverages or food 2 days prior to admission to the clinical site\n* Abstain from any strenuous physical exercise from 4 days prior to admission and during confinement at the clinical site\n\nExclusion Criteria:\n\n* Have a history of relevant drug and/or food allergies, or sensitivity to medications used in the current study\n* Females participants who are currently breastfeeding\n* Have History of alcohol abuse or drug addiction\n* Unable to abstain from tobacco products within the 2 days prior to admission and during confinement at the clinical site\n* Have Positive screen for hepatitis B surface antigen, hepatitis C virus (HCV) antibodies, or human immunodeficiency virus (HIV) 1 and 2 antibodies\n* Consumption of any nutrients known to modulate CYP450 enzymes activity\n* Are immunocompromised\n* Have received live vaccine(s) (including attenuated live vaccines) or Bacillus Calmette-Guérin within 28 days of screening or intend to receive them during the study\n* Have had any malignancy within the past 5 years'}, 'identificationModule': {'nctId': 'NCT06345794', 'briefTitle': 'A Study to Assess LY4100511 (DC-853) in Healthy Adult Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 1, Single-Center, Open-Label, 3-Cohort, Fixed-Sequence, Drug-Drug Interaction Study To Assess The Pharmacokinetics Of LY4100511 (DC-853) When Orally Administered Alone, When Coadministered With Itraconazole, Fluconazole, Or Carbamazepine In Healthy Adult Participants', 'orgStudyIdInfo': {'id': 'DCE853103'}, 'secondaryIdInfos': [{'id': 'J5C-MC-FOAG', 'type': 'OTHER', 'domain': 'DICE Therapeutics, a wholly owned subsidiary of Eli Lilly and Company'}, {'id': 'DCE853103', 'type': 'OTHER', 'domain': 'DICE Therapeutics, a wholly owned subsidiary of Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY4100511 (DC-853) + Itraconazole', 'description': 'Single oral doses of LY4100511 (DC-853) with single and multiple doses of Itraconazole administered orally.', 'interventionNames': ['Drug: LY4100511 (DC-853)', 'Drug: Itraconazole']}, {'type': 'EXPERIMENTAL', 'label': 'LY4100511 (DC-853) + Fluconazole', 'description': 'Single oral doses of LY4100511 (DC-853) with single and multiple doses of fluconazole administered orally.', 'interventionNames': ['Drug: LY4100511 (DC-853)', 'Drug: Fluconazole']}, {'type': 'EXPERIMENTAL', 'label': 'LY4100511 (DC-853) + Carbamazepine', 'description': 'Single oral doses of LY4100511 (DC-853) with single and multiple doses of Carbamazepine administered orally.', 'interventionNames': ['Drug: LY4100511 (DC-853)', 'Drug: Carbamazepine']}], 'interventions': [{'name': 'LY4100511 (DC-853)', 'type': 'DRUG', 'otherNames': ['DC-853'], 'description': 'Administered orally.', 'armGroupLabels': ['LY4100511 (DC-853) + Carbamazepine', 'LY4100511 (DC-853) + Fluconazole', 'LY4100511 (DC-853) + Itraconazole']}, {'name': 'Itraconazole', 'type': 'DRUG', 'description': 'Administered orally.', 'armGroupLabels': ['LY4100511 (DC-853) + Itraconazole']}, {'name': 'Fluconazole', 'type': 'DRUG', 'description': 'Administered orally.', 'armGroupLabels': ['LY4100511 (DC-853) + Fluconazole']}, {'name': 'Carbamazepine', 'type': 'DRUG', 'description': 'Administered orally.', 'armGroupLabels': ['LY4100511 (DC-853) + Carbamazepine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78209', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'ICON San Antonio Clinical Research Unit', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Contact Lilly at 1-800-LillyRx (1-800-545-5979)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}