Open-label Pharmacokinetic Study of Diazoxide Choline Coated vs. Uncoated Formulations

Study Overview
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Brief Summary
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This is a single-center, randomized, open-label, multi-dose crossover study assessing the pharmacokinetic profiles of diazoxide choline coated versus uncoated formulations in healthy volunteers. The primary objective is to compare the pharmacokinetic (PK) profiles of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers under fed conditions. Secondary objectives are to assess diazoxide choline pharmacokinetic (PK) parameters under fasted conditions, and to assess the safety and tolerability of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers.

Official Title
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A Randomized, Open-label, Multi-dose Crossover Study Assessing the Pharmacokinetic Profiles of Diazoxide Choline Coated Versus Uncoated Formulations in Healthy Volunteers

Conditions
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Hypertriglyceridemia

Intervention / Treatment
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* Drug: Diazoxide choline
* Drug: Diazoxide choline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent Healthy male and female subjects 18 to 75 years of age Body mass index (BMI) between 22-35 kg/m2 Fasting glucose ≤ 125 mg/dL and HbA1C ≤ 6.5. Fasting triglyceride ≥100 mg/dL and ≤ 500 mg/dL Not pregnant Exclusion Criteria: Significant underlying medical conditions Clinical laboratory test values outside the accepted range Smokers, tobacco users, or subjects currently using nicotine products Substance abuse History of allergic response(s) to diazoxide or related drugs Recent significant weight loss Use of medication affecting body weight, lipid or glucose metabolism Unable to comply with study procedures

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

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Diazoxide choline controlled-release coated tablets administered orally once daily (Days 1 through 8). Diazoxide choline controlled-release uncoated tablets administered orally once daily (Days 9 through 16). | Drug: Diazoxide choline<br>* Diazoxide choline controlled-release coated tablets versus Diazoxide choline controlled-release uncoated tablets administered orally once daily<br>|
| Experimental: B<br>Diazoxide choline controlled-release uncoated tablets administered orally once daily (Days 1 through 8). Diazoxide choline controlled-release coated tablets administered orally once daily (Days 9 through 16) | Drug: Diazoxide choline<br>* Diazoxide choline controlled-release uncoated tablets versus Diazoxide choline controlled-release coated tablets administered orally once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the pharmacokinetic (PK) profiles of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers under fed conditions. |  | 16 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess diazoxide choline pharmacokinetic (PK) parameters under fasted conditions |  | Study days 8 and 16 | 
| Assess the safety and tolerability of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers. |  | Entire study |