Ignite Creation Date:
2025-12-24 @ 2:03 PM
Ignite Modification Date:
2026-02-20 @ 6:38 PM
Study NCT ID:
NCT03616795
Status:
COMPLETED
Last Update Posted:
2018-11-26
First Post:
2018-08-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of LY3154207 in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000707472', 'term': 'LY3154207'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-11-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-21', 'studyFirstSubmitDate': '2018-08-01', 'studyFirstSubmitQcDate': '2018-08-01', 'lastUpdatePostDateStruct': {'date': '2018-11-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urinary Excretion of LY3154207 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered', 'timeFrame': 'Baseline through 552 hours after administration of study drug', 'description': 'Urinary Excretion of LY3154207 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered'}, {'measure': 'Fecal Excretion of LY3154207 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered', 'timeFrame': 'Baseline through 552 hours after administration of study drug', 'description': 'Fecal Excretion of LY3154207 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics: Maximum Concentration (Cmax) of LY3154207', 'timeFrame': 'Predose through 144 hours after administration of study drug', 'description': 'Pharmacokinetics: Cmax of LY3154207'}, {'measure': 'Pharmacokinetics: Area Under the Concentration Time Curve From Time Zero to Infinity (AUC[0-∞])', 'timeFrame': 'Predose through 144 hours after administration of study drug', 'description': 'Pharmacokinetics: AUC(0-∞)'}, {'measure': 'Total Number of Metabolites', 'timeFrame': 'Baseline through 552 hours after administration of study drug', 'description': 'Total Number of Metabolites'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '33029934', 'type': 'DERIVED', 'citation': 'Wilbraham D, Biglan KM, Svensson KA, Tsai M, Kielbasa W. Safety, Tolerability, and Pharmacokinetics of Mevidalen (LY3154207), a Centrally Acting Dopamine D1 Receptor-Positive Allosteric Modulator (D1PAM), in Healthy Subjects. Clin Pharmacol Drug Dev. 2021 Apr;10(4):393-403. doi: 10.1002/cpdd.874. Epub 2020 Oct 7.'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to measure how much of the study drug gets into the bloodstream and how long it takes the body to get rid of it. This study will involve a single dose of 14C radiolabelled LY3154207. This means that a radioactive substance C14 will be incorporated into the study drug, to investigate the study drug and its breakdown products, to find out how much of these pass from blood into urine, feces and expired air. The study will last about 4 weeks. Screening is required within 28 days prior to the start of the study and follow up is required approximately 7 days after discharge.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a body mass index (BMI) of 19 to 32.0 kilogram per meter square (kg/m²)\n* Are 18 to 50 years old, inclusive, at the time of screening\n\nExclusion Criteria:\n\n* Are currently or have been smokers or users of tobacco or nicotine replacement products within the 3 months prior to admission and/or have positive cotinine at screening or check-in\n* Are unwilling to refrain from consuming caffeine- or xanthine-containing food and drink from 48 hours prior to admission and while resident in the CRU\n* Have consumed grapefruits or grapefruit-containing products, Seville oranges or Seville orange-containing products, star fruits or star fruit-containing products within 7 days prior to dosing or intend to consume during the study\n* Have participated in a \\[14C\\]-study within the last 4 to 6 months prior to admission for this study. The total 12-month exposure from this study and a maximum of 1 other previous \\[14C\\]-study within 6 to 12 months of this study (if the previous studies\' radiation exposure is not known) or a maximum of 2 other previous \\[14C\\]-studies within 4 to 12 months of this study\n* Have a history of clinically significant adverse drug reactions or "drug allergy" to more than 3 types of systemically administered medications (all penicillins and cephalosporins may be considered 1 type of medication for this purpose)'}, 'identificationModule': {'nctId': 'NCT03616795', 'briefTitle': 'Study of LY3154207 in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Disposition of [14C]-LY3154207 Following Oral Administration in Healthy Male Subjects', 'orgStudyIdInfo': {'id': '16303'}, 'secondaryIdInfos': [{'id': 'I7S-MC-HBEE', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY3154207 and [14C]-LY3154207', 'description': 'A single dose of LY3154207 and \\[14C\\]-LY3154207administered orally.', 'interventionNames': ['Drug: LY3154207', 'Drug: [14C]-LY3154207']}], 'interventions': [{'name': 'LY3154207', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['LY3154207 and [14C]-LY3154207']}, {'name': '[14C]-LY3154207', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['LY3154207 and [14C]-LY3154207']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53704', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Covance Clinical Research Inc', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], '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'}}}}