Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2026-03-05 @ 7:53 PM
Study NCT ID:
NCT03913260
Status:
COMPLETED
Last Update Posted:
2019-10-11
First Post:
2019-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Different Injectable Formulations of LY3375880 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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Part A is a crossover design. Part B is a parallel design.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-09', 'studyFirstSubmitDate': '2019-04-11', 'studyFirstSubmitQcDate': '2019-04-11', 'lastUpdatePostDateStruct': {'date': '2019-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale (VAS) Pain Score', 'timeFrame': 'Part A: Within 1-minute post injection', 'description': "The pain VAS is a participant administered single item scale designed to measure pain using a 0-100 millimeter (mm) horizontal VAS. Overall severity of participant's pain is indicated by placing a single mark on the scale from 0 mm (no pain) to 100 mm (severe pain)."}, {'measure': 'Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3375880', 'timeFrame': 'Part B: Predose through Day 85', 'description': 'PK: Cmax of LY3375880'}, {'measure': 'PK: Area Under the Concentration Versus Time Curve (AUC) of LY3375880', 'timeFrame': 'Part B: Predose through Day 85', 'description': 'PK: AUC of LY3375880'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The main purposes of this study are: 1. To learn more about the safety and side effects of different formulations of LY3375880 and 2. To measure how much LY3375880 gets into the blood stream and how long it takes to get out of the body. The study will last about 85 days. Screening may occur up to 28 days prior to enrollment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Are overtly healthy males or females, as determined by medical history and physical examination\n* Have a body mass index of 18.0 to 32.0 kilograms per meter squared (kg/m²) inclusive\n* Females who are not of child-bearing potential\n* Males who agree to use a reliable method of birth control during the study and for 120 days following the final administration of LY3375880\n* Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures\n\nExclusion Criteria:\n\n* Have known allergies to LY3375880, related compounds or any components of the formulation, or history of significant atopy\n* Have participated or are currently enrolled in clinical trials with LY3375880\n* Have infections or evidence of infections\n* Are pregnant, lactating or breast feeding'}, 'identificationModule': {'nctId': 'NCT03913260', 'briefTitle': 'A Study of Different Injectable Formulations of LY3375880 in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Safety, Tolerability, and Pharmacokinetic Study of Different Solution Formulations of LY3375880 Using Investigational Injection Devices in Healthy Subjects', 'orgStudyIdInfo': {'id': '17212'}, 'secondaryIdInfos': [{'id': 'I9N-MC-FCAC', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A: LY3375880 Formulation A', 'description': 'LY3375880 Formulation A administered subcutaneously (SC).', 'interventionNames': ['Drug: LY3375880', 'Device: Autoinjector (AI)']}, {'type': 'EXPERIMENTAL', 'label': 'Part A: LY3375880 Formulation B', 'description': 'LY3375880 Formulation B administered subcutaneously SC.', 'interventionNames': ['Drug: LY3375880', 'Device: Autoinjector (AI)']}, {'type': 'EXPERIMENTAL', 'label': 'Part A: LY3375880 Formulation C', 'description': 'LY3375880 Formulation C administered SC.', 'interventionNames': ['Drug: LY3375880', 'Device: Autoinjector (AI)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part A: Positive Control', 'description': 'Positive Control (buffer matrix, only) administered SC.', 'interventionNames': ['Drug: Buffer Matrix (No LY3375880)', 'Device: Autoinjector (AI)']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: LY3375880 Test 1', 'description': 'LY3375880 Test 1 Formulation administered SC.', 'interventionNames': ['Drug: LY3375880', 'Device: Manual Syringe']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: LY3375880 Test 2', 'description': 'LY3375880 Test 2 Formulation administered SC.', 'interventionNames': ['Drug: LY3375880', 'Device: Manual Syringe']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: LY3375880 Test 3', 'description': 'LY3375880 Test 3 Formulation administered SC.', 'interventionNames': ['Drug: LY3375880', 'Device: Manual Syringe']}], 'interventions': [{'name': 'LY3375880', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['Part A: LY3375880 Formulation A', 'Part A: LY3375880 Formulation B', 'Part A: LY3375880 Formulation C', 'Part B: LY3375880 Test 1', 'Part B: LY3375880 Test 2', 'Part B: LY3375880 Test 3']}, {'name': 'Buffer Matrix (No LY3375880)', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['Part A: Positive Control']}, {'name': 'Autoinjector (AI)', 'type': 'DEVICE', 'description': 'AI used to administer LY3375880 or Buffer Matrix', 'armGroupLabels': ['Part A: LY3375880 Formulation A', 'Part A: LY3375880 Formulation B', 'Part A: LY3375880 Formulation C', 'Part A: Positive Control']}, {'name': 'Manual Syringe', 'type': 'DEVICE', 'description': 'Manual syringe used to inject LY3375880', 'armGroupLabels': ['Part B: LY3375880 Test 1', 'Part B: LY3375880 Test 2', 'Part B: LY3375880 Test 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32117', 'city': 'Daytona Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Covance Clinical Research Inc', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}, {'zip': '75247', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Covance', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], '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'}, 'responsibleParty': {'type': 'SPONSOR'}}}}