Pharmacokinetic Study of Diazoxide Choline in Hypertriglyeridemic Subjects

Phase 1

Completed

• Conditions: Hypertriglyceridmia
• Interventions: Drug: Diazoxide Choline Controlled-Release Tablet

• Registration Number: NCT01211860
• Lead Sponsor: Essentialis, Inc.

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

Study Timeline

• Study First Submitted: 2010-09-28
• Study First Submitted QC: 2010-09-29
• Study First Posted: 2010-09-30
• Study Start: 2010-10
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-09
• Last Update Posted: 2014-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DCCR Treatment	Diazoxide Choline Controlled-Release Tablet	DCCR Treatment 290 mg diazoxide choline

Primary Outcome Measures

Name	Time	Method
Steady-state Pharmacokinetic profile of DCCR	10 days	* Mean concentration-time profile for diazoxide; * Steady-state pharmacokinetic parameters of diazoxide (Cmax(ss), AUC0-inf(ss), and CL/F); * Terminal elimination half-life (t½) of diazoxide

Secondary Outcome Measures

Name	Time	Method
Concentration-Time profile of major metabolite	10 days	* Steady-state pharmacokinetic parameters (Cmax(ss) and AUC0-inf(ss)) of the major metabolite of diazoxide; * Terminal elimination half-life (t½) of the major metabolite of diazoxide; * Metabolite-to-parent ratios at steady-state in terms of Cmax(ss) and AUC0-inf(ss)

Trial Locations

Locations (1)

Cetero; 🇺🇸 Fargo, North Dakota, United States