Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-01-05 @ 5:18 PM
Study NCT ID:
NCT03551769
Status:
COMPLETED
Last Update Posted:
2019-05-29
First Post:
2018-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of Tricaprilin Including Food Effect on Ketone Body Production
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C003637', 'term': 'tricaprylin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2018-08-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-27', 'studyFirstSubmitDate': '2018-05-17', 'studyFirstSubmitQcDate': '2018-05-29', 'lastUpdatePostDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total ketones', 'timeFrame': '1 day', 'description': 'Area Under the Curve (AUC) AUC 0-last'}, {'measure': 'Total ketones', 'timeFrame': '1 day', 'description': 'AUC 0 - 4'}, {'measure': 'Total ketones', 'timeFrame': '1 day', 'description': 'AUC 0 - 6'}, {'measure': 'Total ketones', 'timeFrame': '1 day', 'description': 'AUC 0-8'}, {'measure': 'Total ketones', 'timeFrame': '1 day', 'description': 'Maximum Plasma Concentration (Cmax)'}, {'measure': 'B-hydrodxybutyrate', 'timeFrame': '1 day', 'description': 'AUC 0-last'}, {'measure': 'B-hydroxybutyrate', 'timeFrame': '1 day', 'description': 'AUC 0-4'}, {'measure': 'B-hydroxybutyrate', 'timeFrame': '1 day', 'description': 'AUC 0-6'}, {'measure': 'B-hydroxybutyrate', 'timeFrame': '1 day', 'description': 'AUC 0-8'}, {'measure': 'B-hydroxybutyrate', 'timeFrame': '1 day', 'description': 'Cmax'}, {'measure': 'Acetoacetate', 'timeFrame': '1 day', 'description': 'AUC 0-last'}, {'measure': 'Acetoacetate', 'timeFrame': '1 day', 'description': 'AUC 0-4'}, {'measure': 'Acetoacetate', 'timeFrame': '1 day', 'description': 'AUC 0-6'}, {'measure': 'Acetoacetate', 'timeFrame': '1 day', 'description': 'AUC 0-8'}, {'measure': 'Acetoacetate', 'timeFrame': '1 day', 'description': 'Cmax'}], 'secondaryOutcomes': [{'measure': 'tricaprilin', 'timeFrame': '1 day', 'description': 'AUC 0 - last'}, {'measure': 'tricaprilin', 'timeFrame': '1 day', 'description': 'AUC 0 - 4'}, {'measure': 'tricaprilin', 'timeFrame': '1 day', 'description': 'AUC 0 - 6'}, {'measure': 'tricaprilin', 'timeFrame': '1 day', 'description': 'AUC 0 - 8'}, {'measure': 'tricaprilin', 'timeFrame': '1 day', 'description': 'Time to maximum concentration (Tmax)'}, {'measure': 'tricaprilin', 'timeFrame': '1 day', 'description': 'Cmax'}, {'measure': 'octanoic acid', 'timeFrame': '1 day', 'description': 'AUC 0 - last'}, {'measure': 'octanoic acid', 'timeFrame': '1 day', 'description': 'AUC 0 - 4'}, {'measure': 'octanoic acid', 'timeFrame': '1 day', 'description': 'AUC 0 - 6'}, {'measure': 'octanoic acid', 'timeFrame': '1 day', 'description': 'AUC 0 - 8'}, {'measure': 'octanoic acid', 'timeFrame': '1 day', 'description': 'Tmax'}, {'measure': 'octanoic acid', 'timeFrame': '1 day', 'description': 'Cmax'}, {'measure': 'Computerized Cognitive Battery - Attention', 'timeFrame': '1 day', 'description': 'Rapid Visual Information Processing Test'}, {'measure': 'Computerized Cognitive Battery - Episodic Memory', 'timeFrame': '1 day', 'description': 'Paired Associates Learning Test'}, {'measure': 'Computerized Cognitive Battery - Working Memory', 'timeFrame': '1 day', 'description': 'Spatial Working Memory Test'}, {'measure': 'Computerized Cognitive Battery - Psychomotor Function', 'timeFrame': '1 day', 'description': 'Reaction Time Test'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alzheimer Disease']}, 'descriptionModule': {'briefSummary': 'This is a Phase I, single center, open label, fixed-order, crossover, food-effect, pharmacokinetic (PK) study recruiting healthy, adult, male subjects.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adult male, ages 18 - 55\n* Able to consume a regular diet and one high fat meal; no specific dietary requirements\n* Cohort 2 (Asian subject population) restricted to being of Japanese or Chinese heritage\n\nExclusion Criteria:\n\n* Presence of any illness or condition that, in the opinion of the investigator might confound the study results or poses risk to the subject\n* Has been on a ketogenic diet as supported by review of a food diary\n* Has positive Urine Drug Screen or alcohol results at Screening'}, 'identificationModule': {'nctId': 'NCT03551769', 'briefTitle': 'Pharmacokinetics of Tricaprilin Including Food Effect on Ketone Body Production', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cerecin'}, 'officialTitle': 'A Phase I, Open-label, Fixed-order, Single-dose, 2-Part, Crossover Study to Evaluate the Pharmacokinetics of a Formulation of Tricaprilin (AC-SD-01) Including the Effect of Food on Ketone Body Production in Caucasians and Asians', 'orgStudyIdInfo': {'id': 'AC-18-016_FE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1, Period 1', 'description': 'Study drug administered concurrently with a standard meal', 'interventionNames': ['Drug: tricaprilin', 'Other: standard meal']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 1, Period 2', 'description': 'Study drug administered 30 minutes after a standard meal', 'interventionNames': ['Drug: tricaprilin', 'Other: standard meal']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 1, Period 3', 'description': 'Study drug administered 30 minutes after a high-fat meal', 'interventionNames': ['Drug: tricaprilin', 'Other: high-fat meal']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 1, Period 4', 'description': 'Study drug administered after an overnight fast', 'interventionNames': ['Drug: tricaprilin']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2, Period 1', 'description': 'Study drug administered 30 minutes after a standard meal (Asian)', 'interventionNames': ['Drug: tricaprilin', 'Other: standard meal']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2, Period 2', 'description': 'Study drug administered after an overnight fast (Asian)', 'interventionNames': ['Drug: tricaprilin', 'Other: overnight fast']}], 'interventions': [{'name': 'tricaprilin', 'type': 'DRUG', 'description': 'Tricaprilin formulated as AC-SD-01', 'armGroupLabels': ['Cohort 1, Period 1', 'Cohort 1, Period 2', 'Cohort 1, Period 3', 'Cohort 1, Period 4', 'Cohort 2, Period 1', 'Cohort 2, Period 2']}, {'name': 'standard meal', 'type': 'OTHER', 'description': 'standard meal', 'armGroupLabels': ['Cohort 1, Period 1', 'Cohort 1, Period 2', 'Cohort 2, Period 1']}, {'name': 'high-fat meal', 'type': 'OTHER', 'description': 'high-fat meal', 'armGroupLabels': ['Cohort 1, Period 3']}, {'name': 'overnight fast', 'type': 'OTHER', 'description': 'fasting for at least 9 hours', 'armGroupLabels': ['Cohort 2, Period 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Nucleus Network', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cerecin', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}