Pharmacokinetic Study of Diazoxide Choline in Hypertriglyeridemic Subjects

Completed · Phase 1

Conditions studied: Hypertriglyceridmia

In brief

Once a day oral administration with DCCR is the optimal dosing regimen

Key facts

Study ID

NCT01211860

Run by

Essentialis, Inc.

People needed

9

Starts

2010-10-01

Expected to finish

2010-11-01

Last updated by the study team

2014-01-10

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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 %

You may not qualify if…

• 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

Where it is running

• Cetero — Fargo, North Dakota, United States

Full record on ClinicalTrials.gov

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