Pharmacokinetic Study of Diazoxide Choline in Hypertriglyeridemic Subjects

Study Overview
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Brief Summary
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Once a day oral administration with DCCR is the optimal dosing regimen

Detailed Description
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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.

Official Title
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A Multiple-Dose Pharmacokinetic Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Subjects With Elevated Fasting Triglyceride Levels

Conditions
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Hypertriglyceridmia

Intervention / Treatment
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* Drug: Diazoxide Choline Controlled-Release Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 % Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DCCR Treatment<br>DCCR Treatment 290 mg diazoxide choline | Drug: Diazoxide Choline Controlled-Release Tablet<br>* DCCR 290 mg once a day for 10 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Steady-state Pharmacokinetic profile of DCCR | 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 | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration-Time profile of major metabolite | 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) | 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DCCR, Diazoxide Chonline Controlled-Release Tablet = DCCR, Hypertriglyceridemia, Triglycerides, Pharmacokinetics