Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2026-02-25 @ 6:31 PM
Study NCT ID:
NCT02818335
Status:
COMPLETED
Last Update Posted:
2016-11-04
First Post:
2016-06-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of LY3023414 Formulations and the Effect of Food
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-03', 'studyFirstSubmitDate': '2016-06-28', 'studyFirstSubmitQcDate': '2016-06-28', 'lastUpdatePostDateStruct': {'date': '2016-11-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics (PK): Area under the concentration versus time curve (AUC) from time zero to infinity (AUC[0-inf]) of LY3023414', 'timeFrame': 'Pre-dose through 2 days post-dose in each period'}, {'measure': 'Pharmacokinetics (PK): Area under the concentration from time zero to time t, where t is the last time point with a measurable concentration (AUC [0-tlast]) of LY3023414', 'timeFrame': 'Pre-dose through 2 days post-dose in each period'}, {'measure': 'Pharmacokinetics (PK): Maximum observed drug concentration (Cmax) of LY3023414', 'timeFrame': 'Pre-dose through 2 days post-dose in each period'}, {'measure': 'Pharmacokinetics (PK): Observed time of maximum concentration (tmax)', 'timeFrame': 'Pre-dose through 2 days post-dose in each period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to measure how much LY3023414 (a test formulation and a reference formulation) gets into the blood stream and how long it takes the body to get rid of it.\n\nThe study will also evaluate the effects of a high fat meal on LY3023414 compared to taking LY3023414 on an empty stomach. In addition, the tolerability of the study drug formulations will be evaluated. Information about any side effects that may occur will be collected.\n\nThis study includes 3 periods. Participants will be admitted to the clinical research unit (CRU) one day before dosing in each period. Total study duration is about 21 days, including follow-up. Screening may occur up to 30 days before the first dose of study drug.\n\nThis study is for research purposes only and is not intended to treat any medical conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy surgically sterile or postmenopausal females and sterile males\n* Have a body mass index (BMI) between 18.5 and 32.0 kilograms per meter squared (kg/m²), inclusive at screening\n\nExclusion Criteria:\n\n* Cannot be investigative site personnel directly affiliated with this study or their immediate families. Immediate family is defined as a spouse, biological or legal guardian, child, or sibling\n* Cannot be Lilly employees\n* Have known allergies to LY3023414, related compounds, or any components of the formulation\n* Regularly use known drugs of abuse and/or show positive findings on urinary drug screening\n* Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies\n* Show evidence of hepatitis C and/or positive hepatitis C antibody\n* Show evidence of hepatitis B and/or positive hepatitis B surface antigen'}, 'identificationModule': {'nctId': 'NCT02818335', 'briefTitle': 'A Study of LY3023414 Formulations and the Effect of Food', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Relative Bioavailability and the Effect of Food on the Bioavailability of LY3023414 in Healthy Subjects', 'orgStudyIdInfo': {'id': '15696'}, 'secondaryIdInfos': [{'id': 'I6A-EW-CBBB', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY3023414 Reference Fasted', 'description': 'Single oral dose of LY3023414 (Reference) on day one fasting.', 'interventionNames': ['Drug: LY3023414 Reference Fasted']}, {'type': 'EXPERIMENTAL', 'label': 'LY3023414 Test Fasted', 'description': 'Single oral dose of LY3023414 (Test) on day one fasting.', 'interventionNames': ['Drug: LY3023414 Test Fasted']}, {'type': 'EXPERIMENTAL', 'label': 'LY3023414 Test Fed', 'description': 'Single oral dose of LY3023414 (Test) on day one after a meal.', 'interventionNames': ['Drug: LY3023414 Test Fed']}], 'interventions': [{'name': 'LY3023414 Reference Fasted', 'type': 'DRUG', 'description': 'Administered Orally', 'armGroupLabels': ['LY3023414 Reference Fasted']}, {'name': 'LY3023414 Test Fasted', 'type': 'DRUG', 'description': 'Administered Orally', 'armGroupLabels': ['LY3023414 Test Fasted']}, {'name': 'LY3023414 Test Fed', 'type': 'DRUG', 'description': 'Administered Orally', 'armGroupLabels': ['LY3023414 Test Fed']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32117', 'city': 'Daytona Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Covance Clinical Research Inc', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}], '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'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}