Pharmacokinetic Study of Diazoxide Choline in Hypertriglyeridemic Subjects

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Essentialis, Inc.
• Collaborator: Cetero Research, San Antonio
• Treatments: Choline; Diazoxide

Criteria

Inclusion Criteria:

Basic requirements

1. Healthy male and female subjects 18 to 75 years of age, inclusive at the time of dosing

2. Body mass index (BMI) between 22 and 35 kg/m2

Specific laboratory test results

3. Fasting triglyceride ≥ 150 mg/dL and ≤ 1500 mg/dL

4. Fasting glucose ≤ 110 mg/dL

5. HbA1c ≤ 6.0 %

Exclusion Criteria:

Medications: recent, current, anticipated

1. 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)

2. Thiazide diuretics within 2 weeks prior to Screening Visit

History of allergic reaction or significant intolerance to:

3. Diazoxide

4. Thiazides

5. Sulfonamides

Lifestyle changes

6. Subjects intending to change exercise habits, and/or quit smoking

Specific diagnoses, medical conditions and history

7. Known type I or III hyperlipidemia

8. Known type 1 DM

9. Known type 2 DM

10. 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

11. Any relevant biochemical abnormality interfering with the assessments of the investigational drug