Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-24 @ 4:54 PM
Study NCT ID:
NCT04156750
Status:
COMPLETED
Last Update Posted:
2020-08-19
First Post:
2019-11-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of LY3556050 in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007472', 'term': 'Iohexol'}, {'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D014283', 'term': 'Triiodobenzoic Acids'}, {'id': 'D007463', 'term': 'Iodobenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Part A - Double-blind. Part B - Open label.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Part A - Parallel design. Part B - Open label design.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08-15', 'completionDateStruct': {'date': '2020-08-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-18', 'studyFirstSubmitDate': '2019-11-06', 'studyFirstSubmitQcDate': '2019-11-06', 'lastUpdatePostDateStruct': {'date': '2020-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration', 'timeFrame': 'Baseline through Final Follow-up (up to Week 9)]', 'description': 'A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3556050', 'timeFrame': 'Baseline through Day 17', 'description': 'PK: Cmax of LY3556050'}, {'measure': 'PK: Area Under the Concentration Versus Time Curve During 1 Dosing Interval (AUCτ)', 'timeFrame': 'Baseline through Day 17', 'description': 'PK: AUCτ of LY3556050'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to learn more about the safety of LY3556050 after it is given by mouth to healthy participants. Blood tests will be performed to check how much LY3556050 gets into the bloodstream and how long the body takes to get rid of it. Each enrolled participant will receive multiple doses of LY3556050 or placebo and will remain in the study for up to 31 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy males or females of nonchild bearing potential, as determined by medical history\n* Have safety laboratory results within normal references ranges\n* Weight at least 50 kilograms (kg)\n\nExclusion Criteria:\n\n* Have known allergies to LY3556050, iodine, metformin and related compounds\n* Abnormal electrocardiogram (ECG) or blood pressure at screening\n* Significant history of current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or endocrine disorders\n* Show evidence of active renal disease with estimated glomerular filtration rate (GFR) \\<90 milliliters per minute per 1.73 meters squared'}, 'identificationModule': {'nctId': 'NCT04156750', 'briefTitle': 'A Study of LY3556050 in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Multiple-Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study With LY3556050 in Healthy Subjects', 'orgStudyIdInfo': {'id': '17612'}, 'secondaryIdInfos': [{'id': 'J2P-MC-LXBA', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY3556050 (Part A)', 'description': 'LY3556050 administered orally.', 'interventionNames': ['Drug: LY3556050']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (Part A)', 'description': 'Placebo administered orally.', 'interventionNames': ['Drug: Placebo']}, {'type': 'OTHER', 'label': 'Iohexol (Part B)', 'description': 'Iohexol given intravenously (IV). (Part B is optional.)', 'interventionNames': ['Drug: Iohexol']}, {'type': 'OTHER', 'label': 'Metformin (Part B)', 'description': 'Metformin given orally. (Part B is optional.)', 'interventionNames': ['Drug: Metformin']}, {'type': 'EXPERIMENTAL', 'label': 'LY3556050+ Iohexol (Part B)', 'description': 'Iohexol given intravenously (IV) coadministered with oral doses of LY3556050. (Part B is optional.)', 'interventionNames': ['Drug: LY3556050', 'Drug: Iohexol']}, {'type': 'EXPERIMENTAL', 'label': 'LY3556050 + Metformin (Part B)', 'description': 'Metformin given orally coadministered with oral doses of LY3556050. (Part B is optional.)', 'interventionNames': ['Drug: LY3556050', 'Drug: Metformin']}], 'interventions': [{'name': 'LY3556050', 'type': 'DRUG', 'description': 'Administered orally.', 'armGroupLabels': ['LY3556050 (Part A)', 'LY3556050 + Metformin (Part B)', 'LY3556050+ Iohexol (Part B)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered orally.', 'armGroupLabels': ['Placebo (Part A)']}, {'name': 'Iohexol', 'type': 'DRUG', 'description': 'Administered IV.', 'armGroupLabels': ['Iohexol (Part B)', 'LY3556050+ Iohexol (Part B)']}, {'name': 'Metformin', 'type': 'DRUG', 'description': 'Administered orally.', 'armGroupLabels': ['LY3556050 + Metformin (Part B)', 'Metformin (Part B)']}]}, 'contactsLocationsModule': {'locations': [{'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'}}}}