Pharmacokinetic Study of Diazoxide Choline in Hypertriglyeridemic Subjects

Essentialis

Status and phase: Completed; Phase 1

Conditions: Hypertriglyceridmia

Treatments: Drug: Diazoxide Choline Controlled-Release Tablet

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT01211860

PK015

Details and patient eligibility

About

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

Full 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 A total of 10 subjects will be enrolled in the study at 1 site in the USA.

Enrollment: 9 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

9 participants in 1 patient group

DCCR Treatment

Experimental group

Description:

DCCR Treatment 290 mg diazoxide choline

Treatment:

Drug: Diazoxide Choline Controlled-Release Tablet