Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-25 @ 5:36 PM
Study NCT ID:
NCT06193304
Status:
COMPLETED
Last Update Posted:
2024-01-05
First Post:
2023-12-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Pharmacokinetic Parameters and Safety of Eliglustat Absorption Through the Mouth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005776', 'term': 'Gaucher Disease'}], 'ancestors': [{'id': 'D013106', 'term': 'Sphingolipidoses'}, {'id': 'D020140', 'term': 'Lysosomal Storage Diseases, Nervous System'}, {'id': 'D020739', 'term': 'Brain Diseases, Metabolic, Inborn'}, {'id': 'D001928', 'term': 'Brain Diseases, Metabolic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008064', 'term': 'Lipidoses'}, {'id': 'D008052', 'term': 'Lipid Metabolism, Inborn Errors'}, {'id': 'D016464', 'term': 'Lysosomal Storage Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C522917', 'term': 'eliglustat'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2014-09-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-21', 'studyFirstSubmitDate': '2023-12-21', 'studyFirstSubmitQcDate': '2023-12-21', 'lastUpdatePostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-09-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma pharmacokinetic (PK) parameter: Cmax', 'timeFrame': 'Multiple timepoints on Day 1', 'description': 'Maximum plasma concentration observed (Cmax)'}, {'measure': 'Plasma pharmacokinetic (PK) parameter tmax', 'timeFrame': 'Multiple timepoints on Day 1', 'description': 'Time to reach Cmax (tmax)'}, {'measure': 'Plasma pharmacokinetic (PK) parameter AUClast', 'timeFrame': 'Multiple timepoints on Day 1', 'description': 'Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to the real time tlast (AUClast)'}, {'measure': 'Plasma pharmacokinetic (PK) parameter AUC 0-2h', 'timeFrame': 'Multiple timepoints on Day 1', 'description': 'Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to 2 hours (h) post dose (AUC0-2h)'}, {'measure': 'Plasma pharmacokinetic (PK) parameter AUC 2-4h', 'timeFrame': 'Multiple timepoints on Day 1', 'description': 'Area under the plasma concentration versus time curve calculated using the trapezoidal method from time 2 hours post dose to 4 hours post dose (AUC2-4h)'}, {'measure': 'Plasma pharmacokinetic (PK) parameter AUC 4-6h', 'timeFrame': 'Multiple timepoints on Day 1', 'description': 'Area under the plasma concentration versus time curve calculated using the trapezoidal method from time 4 hours post dose to 6 hours post dose (AUC4-6h)'}, {'measure': 'Plasma pharmacokinetic (PK) parameter tlast', 'timeFrame': 'Multiple timepoints on Day 1'}], 'secondaryOutcomes': [{'measure': 'Treatment emergent adverse events during the study', 'timeFrame': 'Up to Day 3'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Gaucher's Disease"]}, 'descriptionModule': {'briefSummary': 'A study to assess the absorption of eliglustat through the mouth in healthy subjects and the safety of any systemic exposure resulting from oral surface absorption of eliglustat in healthy subjects.', 'detailedDescription': 'Duration of the study for each subject, not including screening, will be 3 days including follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nBody weight between 50.0 and 100.0 kg, inclusive, for males, and between 40.0 and 90.0 kg, inclusive, for females, body mass index between 18.0 and 30.0 kg/m2, inclusive.\n\nHaving given written informed consent prior to undertaking any study-related procedure.\n\nCertified as healthy by a comprehensive clinical assessment (detailed medical history, complete physical examination, laboratory parameters, and ecg).\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\nAny history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness.\n\nAny subject who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.\n\nThe above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.'}, 'identificationModule': {'nctId': 'NCT06193304', 'acronym': 'Acronym', 'briefTitle': 'A Study to Evaluate Pharmacokinetic Parameters and Safety of Eliglustat Absorption Through the Mouth', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'An Open-label Study to Assess the Absorption Through the Mouth After Three Repeated 50 mg Doses of Eliglustat Solution, Separated by 2-hour Intervals, Held in the Mouth for 30 Seconds With Swishing But Without Ingestion, in Healthy Subjects', 'orgStudyIdInfo': {'id': 'PKM14187'}, 'secondaryIdInfos': [{'id': 'U1111-1294-8055', 'type': 'REGISTRY', 'domain': 'ICTRP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Eliglustat', 'description': 'Three repeated doses of eliglustat solution, separated by 2-hour intervals, held in the mouth for 30 seconds with swishing but without ingestion', 'interventionNames': ['Drug: Eliglustat']}], 'interventions': [{'name': 'Eliglustat', 'type': 'DRUG', 'otherNames': ['GZ385660', 'CERDELGA'], 'description': 'Pharmaceutical form:solution -Route of administration: Oral wihtout ingestion', 'armGroupLabels': ['Eliglustat']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47710', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Covance Clinical Researsh Unit', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}