Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2026-02-02 @ 12:01 PM
Study NCT ID:
NCT02562768
Status:
COMPLETED
Last Update Posted:
2017-03-21
First Post:
2015-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of LY3154207 in Healthy Participants and Participants With Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000707472', 'term': 'LY3154207'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-20', 'studyFirstSubmitDate': '2015-09-28', 'studyFirstSubmitQcDate': '2015-09-28', 'lastUpdatePostDateStruct': {'date': '2017-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03-03', '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 study completion (Day 15) in each part.'}], 'secondaryOutcomes': [{'measure': 'Plasma (blood) Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3154207', 'timeFrame': 'At multiple time points from baseline through day 15 in each part'}, {'measure': 'Plasma (blood) Pharmacokinetics: Maximum Concentration (Cmax) of LY3154207', 'timeFrame': 'At multiple time points from baseline through day 15 in each part'}, {'measure': 'Plasma (blood) Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3154207 after a High-Calorie Meal', 'timeFrame': 'Baseline through 24 hours after administration of study drug on Day 10 in Part A.'}, {'measure': 'Plasma (blood) Pharmacokinetics: Maximum Concentration (Cmax) of LY3154207 after a High-Calorie Meal', 'timeFrame': 'Baseline through 24 hours after administration of study drug on Day 10 in Part A.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ["Parkinson's Disease"]}, 'referencesModule': {'references': [{'pmid': '34664427', 'type': 'DERIVED', 'citation': 'Wilbraham D, Biglan KM, Svensson KA, Tsai M, Pugh M, Ardayfio P, Kielbasa W. Safety, Tolerability, and Pharmacokinetics of Mevidalen (LY3154207), a Centrally Acting Dopamine D1 Receptor-Positive Allosteric Modulator, in Patients With Parkinson Disease. Clin Pharmacol Drug Dev. 2022 Mar;11(3):324-332. doi: 10.1002/cpdd.1039. Epub 2021 Oct 19.'}, {'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.'}], 'seeAlsoLinks': [{'url': "http://www.lillytrialguide.com/en-US/studies/parkinson's-disease/HBEC#?postal=", 'label': "Click here for more information about this study: A Study of LY3154207 in Participants With Parkinson's Disease (Part B)"}]}, 'descriptionModule': {'briefSummary': "This two-part study will evaluate how safe LY3154207 is and the effects it has on the body.\n\nPart A will include healthy participants. Each participant will receive daily doses of LY3154207 or placebo for 14 days. Part A will last approximately 4 weeks including a 17 day stay in the clinical research unit (CRU) and follow-up.\n\nPart B is contingent on the results of Part A. Part B will include participants with Parkinson's disease. Each participant will receive daily doses of LY3154207 or placebo for 14 days. Part B will last approximately 4 weeks including a 17 day stay in the CRU and follow-up.\n\nBoth Part A and Part B will require screening within 30 days prior to the start of the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nPart A:\n\n* Overtly healthy males or females, as determined by medical history and physical examination\n* Female participants not of child-bearing potential\n\nPart B:\n\n* Have a clinical diagnosis of idiopathic Parkinson's disease for at least 1 year and on stable medication for at least 4 weeks\n\nPart A and B\n\n* Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures\n* Have given written informed consent\n* Have a body mass index (BMI) of 18.0 to 29.9 kilograms per square meter (kg/m²)\n\nExclusion Criteria:\n\n* Have participated, in the last 30 days, in a clinical trial involving an investigational product\n* Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders capable of significantly altering the absorption, metabolism or elimination of drugs; or constituting a risk when taking the study medication; or interfering with the interpretation of study data"}, 'identificationModule': {'nctId': 'NCT02562768', 'briefTitle': "A Study of LY3154207 in Healthy Participants and Participants With Parkinson's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': "Multiple-Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study of LY3154207 in Healthy Subjects and Subjects With Parkinson's Disease", 'orgStudyIdInfo': {'id': '15512'}, 'secondaryIdInfos': [{'id': 'I7S-EW-HBEC', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY3154207', 'description': 'LY3154207 administered orally once daily in multiple-ascending dose cohorts for 14 days.', 'interventionNames': ['Drug: LY3154207']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo matching LY3154207 administered once daily for 14 days.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'LY3154207', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['LY3154207']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91206', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Parexel International LLC', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '32806', 'city': 'Orlanda', 'state': 'Florida', 'country': 'United States', 'facility': 'Compass Research'}, {'zip': '32162', 'city': 'The Villages', 'state': 'Florida', 'country': 'United States', 'facility': 'Compass Research', 'geoPoint': {'lat': 28.93408, 'lon': -81.95994}}], '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'}}}}