Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-28 @ 12:01 AM
Study NCT ID:
NCT01211860
Status:
COMPLETED
Last Update Posted:
2014-01-10
First Post:
2010-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Study of Diazoxide Choline in Hypertriglyeridemic Subjects
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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-09', 'studyFirstSubmitDate': '2010-09-28', 'studyFirstSubmitQcDate': '2010-09-29', 'lastUpdatePostDateStruct': {'date': '2014-01-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Steady-state Pharmacokinetic profile of DCCR', 'timeFrame': '10 days', 'description': '* Mean concentration-time profile for diazoxide\n* Steady-state pharmacokinetic parameters of diazoxide (Cmax(ss), AUC0-inf(ss), and CL/F)\n* Terminal elimination half-life (t½) of diazoxide'}], 'secondaryOutcomes': [{'measure': 'Concentration-Time profile of major metabolite', 'timeFrame': '10 days', 'description': '* Steady-state pharmacokinetic parameters (Cmax(ss) and AUC0-inf(ss)) of the major metabolite of diazoxide\n* Terminal elimination half-life (t½) of the major metabolite of diazoxide\n* Metabolite-to-parent ratios at steady-state in terms of Cmax(ss) and AUC0-inf(ss)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['DCCR', 'Diazoxide Chonline Controlled-Release Tablet = DCCR', 'Hypertriglyceridemia', 'Triglycerides', 'Pharmacokinetics'], 'conditions': ['Hypertriglyceridmia']}, 'descriptionModule': {'briefSummary': 'Once a day oral administration with DCCR is the optimal dosing regimen', 'detailedDescription': 'POPULATION The population will consist of generally healthy subjects with elevated fasting triglyceride levels in the range of ≥ 150 mg/dL and ≤ 1500 mg/dL at the Screening Visit.\n\nNumber of Subjects A total of 10 subjects will be enrolled in the study at 1 site in the USA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nBasic requirements\n\n1. Healthy male and female subjects 18 to 75 years of age, inclusive at the time of dosing\n2. Body mass index (BMI) between 22 and 35 kg/m2\n\n Specific laboratory test results\n3. Fasting triglyceride ≥ 150 mg/dL and ≤ 1500 mg/dL\n4. Fasting glucose ≤ 110 mg/dL\n5. HbA1c ≤ 6.0 %\n\nExclusion Criteria:\n\nMedications: recent, current, anticipated\n\n1. Thyroid hormones or preparations within 1 month prior to Screening Visit (except in subjects on stable dose of replacement therapy for at least 1 month)\n2. Thiazide diuretics within 2 weeks prior to Screening Visit\n\n History of allergic reaction or significant intolerance to:\n3. Diazoxide\n4. Thiazides\n5. Sulfonamides\n\n Lifestyle changes\n6. Subjects intending to change exercise habits, and/or quit smoking\n\n Specific diagnoses, medical conditions and history\n7. Known type I or III hyperlipidemia\n8. Known type 1 DM\n9. Known type 2 DM\n10. Any other clinically significant endocrine, cardiovascular, pulmonary, neurological, psychiatric, hepatic, gastrointestinal, hematological, renal, or dermatological disease interfering with the assessments of the investigational drug, according to the Investigator\n\n Specific laboratory test results\n11. Any relevant biochemical abnormality interfering with the assessments of the investigational drug'}, 'identificationModule': {'nctId': 'NCT01211860', 'briefTitle': 'Pharmacokinetic Study of Diazoxide Choline in Hypertriglyeridemic Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Essentialis, Inc.'}, 'officialTitle': 'A Multiple-Dose Pharmacokinetic Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Subjects With Elevated Fasting Triglyceride Levels', 'orgStudyIdInfo': {'id': 'PK015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DCCR Treatment', 'description': 'DCCR Treatment 290 mg diazoxide choline', 'interventionNames': ['Drug: Diazoxide Choline Controlled-Release Tablet']}], 'interventions': [{'name': 'Diazoxide Choline Controlled-Release Tablet', 'type': 'DRUG', 'description': 'DCCR 290 mg once a day for 10 days', 'armGroupLabels': ['DCCR Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58104', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Cetero', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}], 'overallOfficials': [{'name': 'Alan K Copa, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cetero Research - Fargo, ND'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Essentialis, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Cetero Research, San Antonio', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR'}}}}