A Randomized, Open-label, Multi-dose Crossover Study Assessing the Pharmacokinetic Profiles of Diazoxide Choline Coated Versus Uncoated Formulations in Healthy Volunteers
Overview
- Phase
- Phase 1
- Intervention
- Diazoxide choline
- Conditions
- Hypertriglyceridemia
- Sponsor
- Essentialis, Inc.
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Compare the pharmacokinetic (PK) profiles of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers under fed conditions.
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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.
- •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
Arms & Interventions
A
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).
Intervention: Diazoxide choline
B
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)
Intervention: Diazoxide choline
Outcomes
Primary Outcomes
Compare the pharmacokinetic (PK) profiles of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers under fed conditions.
Time Frame: 16 days
Secondary Outcomes
- 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)