Ignite Creation Date:
2025-12-24 @ 7:08 PM
Ignite Modification Date:
2025-12-28 @ 4:47 PM
Study NCT ID:
NCT00688857
Status:
COMPLETED
Last Update Posted:
2010-11-08
First Post:
2008-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open-label Pharmacokinetic Study of Diazoxide Choline Coated vs. Uncoated Formulations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015228', 'term': 'Hypertriglyceridemia'}], 'ancestors': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-04', 'studyFirstSubmitDate': '2008-05-28', 'studyFirstSubmitQcDate': '2008-05-29', 'lastUpdatePostDateStruct': {'date': '2010-11-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare the pharmacokinetic (PK) profiles of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers under fed conditions.', 'timeFrame': '16 days'}], 'secondaryOutcomes': [{'measure': 'Assess diazoxide choline pharmacokinetic (PK) parameters under fasted conditions', 'timeFrame': 'Study days 8 and 16'}, {'measure': 'Assess the safety and tolerability of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers.', 'timeFrame': 'Entire study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypertriglyceridemia']}, 'descriptionModule': {'briefSummary': 'This is a single-center, randomized, open-label, multi-dose crossover study assessing the pharmacokinetic profiles of diazoxide choline coated versus uncoated formulations in healthy volunteers. The primary objective is to compare the pharmacokinetic (PK) profiles of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers under fed conditions. Secondary objectives are to assess diazoxide choline pharmacokinetic (PK) parameters under fasted conditions, and to assess the safety and tolerability of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent\n* Healthy male and female subjects 18 to 75 years of age\n* Body mass index (BMI) between 22-35 kg/m2\n* Fasting glucose ≤ 125 mg/dL and HbA1C ≤ 6.5.\n* Fasting triglyceride ≥100 mg/dL and ≤ 500 mg/dL\n* Not pregnant\n\nExclusion Criteria:\n\n* Significant underlying medical conditions\n* Clinical laboratory test values outside the accepted range\n* Smokers, tobacco users, or subjects currently using nicotine products\n* Substance abuse\n* History of allergic response(s) to diazoxide or related drugs\n* Recent significant weight loss\n* Use of medication affecting body weight, lipid or glucose metabolism\n* Unable to comply with study procedures'}, 'identificationModule': {'nctId': 'NCT00688857', 'briefTitle': 'Open-label Pharmacokinetic Study of Diazoxide Choline Coated vs. Uncoated Formulations', 'organization': {'class': 'INDUSTRY', 'fullName': 'Essentialis, Inc.'}, 'officialTitle': 'A Randomized, Open-label, Multi-dose Crossover Study Assessing the Pharmacokinetic Profiles of Diazoxide Choline Coated Versus Uncoated Formulations in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'PK008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Diazoxide choline controlled-release coated tablets administered orally once daily (Days 1 through 8). Diazoxide choline controlled-release uncoated tablets administered orally once daily (Days 9 through 16).', 'interventionNames': ['Drug: Diazoxide choline']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'description': 'Diazoxide choline controlled-release uncoated tablets administered orally once daily (Days 1 through 8). Diazoxide choline controlled-release coated tablets administered orally once daily (Days 9 through 16)', 'interventionNames': ['Drug: Diazoxide choline']}], 'interventions': [{'name': 'Diazoxide choline', 'type': 'DRUG', 'description': 'Diazoxide choline controlled-release coated tablets versus Diazoxide choline controlled-release uncoated tablets administered orally once daily', 'armGroupLabels': ['A']}, {'name': 'Diazoxide choline', 'type': 'DRUG', 'description': 'Diazoxide choline controlled-release uncoated tablets versus Diazoxide choline controlled-release coated tablets administered orally once daily', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58104', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'PRACS Institute, Ltd. - Cetero Research', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}], 'overallOfficials': [{'name': 'Alan K. Copa, Pharm. D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PRACS Institute, Ltd. - Cetero Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Essentialis, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Cetero Research, San Antonio', 'class': 'NETWORK'}], 'responsibleParty': {'oldNameTitle': 'Neil M Cowen, PhD/Chief Scientific Officer', 'oldOrganization': 'Essentialis, Inc'}}}}