Status:
COMPLETED
Pharmacokinetic Study of Diazoxide Choline in Hypertriglyeridemic Subjects
Lead Sponsor:
Essentialis, Inc.
Collaborating Sponsors:
Cetero Research, San Antonio
Conditions:
Hypertriglyceridmia
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
Once a day oral administration with DCCR is the optimal dosing regimen
Detailed Description
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. Number of Subjects ...
Eligibility Criteria
Inclusion
- Basic requirements
- Healthy male and female subjects 18 to 75 years of age, inclusive at the time of dosing
- Body mass index (BMI) between 22 and 35 kg/m2
- Specific laboratory test results
- Fasting triglyceride ≥ 150 mg/dL and ≤ 1500 mg/dL
- Fasting glucose ≤ 110 mg/dL
- HbA1c ≤ 6.0 %
Exclusion
- Medications: recent, current, anticipated
- 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)
- Thiazide diuretics within 2 weeks prior to Screening Visit
- History of allergic reaction or significant intolerance to:
- Diazoxide
- Thiazides
- Sulfonamides
- Lifestyle changes
- Subjects intending to change exercise habits, and/or quit smoking
- Specific diagnoses, medical conditions and history
- Known type I or III hyperlipidemia
- Known type 1 DM
- Known type 2 DM
- 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
- Specific laboratory test results
- Any relevant biochemical abnormality interfering with the assessments of the investigational drug
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01211860
Start Date
October 1 2010
End Date
November 1 2010
Last Update
January 10 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cetero
Fargo, North Dakota, United States, 58104