Status:
COMPLETED
Open-label Pharmacokinetic Study of Diazoxide Choline Coated vs. Uncoated Formulations
Lead Sponsor:
Essentialis, Inc.
Collaborating Sponsors:
Cetero Research, San Antonio
Conditions:
Hypertriglyceridemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
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 p...
Eligibility Criteria
Inclusion
- Signed informed consent
- Healthy male and female subjects 18 to 75 years of age
- Body mass index (BMI) between 22-35 kg/m2
- Fasting glucose ≤ 125 mg/dL and HbA1C ≤ 6.5.
- Fasting triglyceride ≥100 mg/dL and ≤ 500 mg/dL
- Not pregnant
Exclusion
- Significant underlying medical conditions
- Clinical laboratory test values outside the accepted range
- Smokers, tobacco users, or subjects currently using nicotine products
- Substance abuse
- History of allergic response(s) to diazoxide or related drugs
- Recent significant weight loss
- Use of medication affecting body weight, lipid or glucose metabolism
- Unable to comply with study procedures
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2008
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00688857
Start Date
May 1 2008
End Date
July 1 2008
Last Update
November 8 2010
Active Locations (1)
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1
PRACS Institute, Ltd. - Cetero Research
Fargo, North Dakota, United States, 58104