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

Essentialis, Inc.12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypertriglyceridemia

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

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

Time frame: Study days 8 and 16

Assess the safety and tolerability of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers.

Time frame: Entire study