Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-26 @ 2:41 AM
Study NCT ID:
NCT05341102
Status:
COMPLETED
Last Update Posted:
2022-04-22
First Post:
2022-04-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Single and Repeated Doses of LY3556050 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'], 'maskingDescription': 'All the participants will be double blinded except for LY3556050 (Part 1) - Cohort 7 which will be open label.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2017-06-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-18', 'studyFirstSubmitDate': '2022-04-18', 'studyFirstSubmitQcDate': '2022-04-18', 'lastUpdatePostDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration', 'timeFrame': 'Baseline through Day 30', 'description': 'A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module'}, {'measure': 'Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3556050 (Part 1)', 'timeFrame': 'Predose on day 1 until Day 3 (Cohorts 1 to 7), and Predose on Day 8 until Day 10 (Only for Cohort 7)', 'description': 'PK: Cmax of LY3556050 (Part 1)'}, {'measure': 'PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3556050 (Part 1)', 'timeFrame': 'Predose on day 1 until Day 3 (Cohorts 1 to 7), and Predose on Day 8 until Day 10 (Only for Cohort 7)', 'description': 'PK: AUC\\[0-∞\\] of LY3556050 (Part 1)'}, {'measure': 'PK: Fraction of LY3556050 Excreted in 48-hour Urine (fe[0-48]) (Part 1)', 'timeFrame': 'Predose on day 1 until Day 3 (Cohort 7), and Predose on Day 8 until Day 10 (Cohort 7)', 'description': 'PK: fe\\[0-48\\] of LY3556050 (Part 1)'}, {'measure': 'PK: Cmax of LY3556050 (Part 2)', 'timeFrame': 'Predose up to Postdose on Day 10', 'description': 'PK: Cmax of LY3556050 (Part 2)'}, {'measure': 'PK: Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC[0-24]) of LY3556050 (Part 2)', 'timeFrame': 'Predose up to Postdose on Day 10', 'description': 'PK: AUC\\[0-24\\] of LY3556050 (Part 2)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to conduct blood tests to measure how much LY3556050 is in the bloodstream and to determine if any age, gender, or food effects exist. The study will also evaluate the safety of LY3556050. This is a 2-part study. In Part 1, single increasing doses of LY3556050 will be given orally and participants will be confined for a 5-day period. In Part 2, multiple increasing doses of LY3556050 will be given orally and participants will be confined for a 14-day period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Are overtly healthy as determined by medical evaluation.\n* Participants with a body mass index (BMI) of 18.0 to 35.0 kilograms per square meter (kg/m²) and have body weight of 50 kg or more.\n\nExclusion Criteria:\n\n* Has any history of or active cardiac disease, including congestive heart failure, angina, any arrhythmia, or clinically significant findings on Electrocardiogram (ECG).\n* Has diabetes mellitus, acromegaly, clinically active thyroid disease, or other active endocrinopathy.\n* Has asthma or other severe respiratory disease.\n* Is pregnant, lactating, or planning a pregnancy.\n* Has active alcohol or substance abuse or history of alcohol or substance abuse within the 6 months prior to randomization.\n* Any abnormal laboratory finding or vital signs outside specified parameters.'}, 'identificationModule': {'nctId': 'NCT05341102', 'briefTitle': 'A Study of Single and Repeated Doses of LY3556050 in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Study to Evaluate the Safety and Pharmacokinetics of Single and Repeated Doses of CNTX-0290 in Healthy Subjects', 'orgStudyIdInfo': {'id': '18327'}, 'secondaryIdInfos': [{'id': 'J2P-MC-LXBB', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY3556050 (Part 1)', 'description': 'Participants will receive single ascending doses of LY3556050 orally.', 'interventionNames': ['Drug: LY3556050']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo (Part 1)', 'description': 'Participants will receive placebo orally.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'LY3556050 (Part 2)', 'description': 'Participants will receive multiple ascending doses of LY3556050 orally.', 'interventionNames': ['Drug: LY3556050']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo (Part 2)', 'description': 'Participants will receive placebo orally.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'LY3556050', 'type': 'DRUG', 'otherNames': ['CNTX-0290'], 'description': 'Administered orally.', 'armGroupLabels': ['LY3556050 (Part 1)', 'LY3556050 (Part 2)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered orally.', 'armGroupLabels': ['Placebo (Part 1)', 'Placebo (Part 2)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45227', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Medpace Clinical Pharmacology, LLC', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], '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'}}}}