Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2026-03-04 @ 10:56 PM
Study NCT ID:
NCT02893618
Status:
UNKNOWN
Last Update Posted:
2016-09-09
First Post:
2016-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A 5 Treatment Period Pharmacokinetic Study Evaluating Dose Proportionality and Food Effects of Diazoxide Choline Controlled-Release Tablet (DCCR)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011218', 'term': 'Prader-Willi Syndrome'}], 'ancestors': [{'id': 'D008607', 'term': 'Intellectual Disability'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D025063', 'term': 'Chromosome Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D000096803', 'term': 'Imprinting Disorders'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-09-07', 'studyFirstSubmitDate': '2016-08-30', 'studyFirstSubmitQcDate': '2016-09-02', 'lastUpdatePostDateStruct': {'date': '2016-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic parameters: Cmax', 'timeFrame': 'up to 24 hours', 'description': 'Cmax derived from PK samples taken at 0, 1, 3, 6, 9, 12, 15, 18, 21 and 24 hours post-dose'}, {'measure': 'Pharmacokinetic parameters: AUC0-24', 'timeFrame': 'up to 24 hours', 'description': 'AUC0-24 derived from PK samples taken at 0, 1, 3, 6, 9, 12, 15, 18, 21 and 24 hours'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic parameters: CL/F', 'timeFrame': 'up to 24 hours', 'description': 'CL/F derived from PK samples taken at 0, 1, 3, 6, 9, 12, 15, 18, 21 and 24 hours'}, {'measure': 'Pharmacokinetic parameters: Tmax', 'timeFrame': 'up to 24 hours', 'description': 'Tmax derived from PK samples taken at 0, 1, 3, 6, 9, 12, 15, 18, 21 and 24 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Prader-Willi Syndrome']}, 'descriptionModule': {'briefSummary': 'Open label, parallel-group, single site, 5 treatment-period study with 4 dose levels of DCCR, 1 of which is administered both with and without food.', 'detailedDescription': 'Open label, parallel-group, single site, 5 treatment-period study with 4 dose levels of DCCR, 1 of which is administered both with and without food, with a 10 Day washout period between treatments. There will be 8 treatment sequences with 4 subjects randomized to each.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to follow verbal and written instructions\n* Informed consent form signed by the subject\n* Completed screening within 7 days prior to dosing\n* BMI between 18.5 and 35 kg/m2\n* Generally healthy\n* fasting glucose less than or equal to 100 mg/dL\n* HbA1c less than or equal to 6%\n\nExclusion Criteria:\n\n* Pregnancy or breast feeding\n* absence of contraception\n* administration of investigational drug within 1 month prior to screening\n* anticipated requirement for prohibited medication (systemic corticosteroids or anti-diabetic medications)\n* allergic reaction to or significant intolerance of diazoxide, thiazides or sulfonamides\n* known type 1 or type 2 diabetes mellitus\n* congestive heart failure\n* gastric bypass surgery\n* history of drug or alcohol abuse'}, 'identificationModule': {'nctId': 'NCT02893618', 'briefTitle': 'A 5 Treatment Period Pharmacokinetic Study Evaluating Dose Proportionality and Food Effects of Diazoxide Choline Controlled-Release Tablet (DCCR)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Essentialis, Inc.'}, 'officialTitle': 'A 5 Treatment Period Crossover Pharmacokinetic Study Evaluating Dose Proportionality and Food Effects of Diazoxide Choline Controlled-Release Tablet (DCCR)', 'orgStudyIdInfo': {'id': 'PK024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DCCR 75 mg fasted', 'description': 'Administered a single 75 mg dose of DCCR after an overnight fast followed by 4 hours of fasting', 'interventionNames': ['Drug: Diazoxide choline controlled-release tablet']}, {'type': 'EXPERIMENTAL', 'label': 'DCCR 150 mg fasted', 'description': 'Administered a single 150 mg dose of DCCR after an overnight fast followed by 4 hours of fasting', 'interventionNames': ['Drug: Diazoxide choline controlled-release tablet']}, {'type': 'EXPERIMENTAL', 'label': 'DCCR 300 mg fasted', 'description': 'Administered a single 300 mg dose of DCCR after an overnight fast followed by 4 hours of fasting', 'interventionNames': ['Drug: Diazoxide choline controlled-release tablet']}, {'type': 'EXPERIMENTAL', 'label': 'DCCR 450 mg fasted', 'description': 'Administered a single 450 mg dose of DCCR after an overnight fast followed by 4 hours of fasting', 'interventionNames': ['Drug: Diazoxide choline controlled-release tablet']}, {'type': 'EXPERIMENTAL', 'label': 'DCCR 300 mg fed', 'description': 'Administered a single 300 mg dose of DCCR after a standardized meal', 'interventionNames': ['Drug: Diazoxide choline controlled-release tablet']}], 'interventions': [{'name': 'Diazoxide choline controlled-release tablet', 'type': 'DRUG', 'otherNames': ['DCCR'], 'description': 'QD tablet formulation of choline salt of diazoxide', 'armGroupLabels': ['DCCR 150 mg fasted', 'DCCR 300 mg fasted', 'DCCR 300 mg fed', 'DCCR 450 mg fasted', 'DCCR 75 mg fasted']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Essentialis, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}