Open-Label, Single- and Multiple-Dose Pharmacokinetic Study of Diazoxide Choline

Essentialis, Inc.

Overview

This is a single-center, randomized, open-label, single- and multiple-dose, five-treatment, two-period, four-way parallel study comparing the pharmacokinetics (PK) of Diazoxide Choline Controlled-Release Tablet (DCCR) administered orally under fed and fasting conditions at two dose levels.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Hypertriglyceridemia

Interventions

Diazoxide cholineDRUG

A single dose low dose DCCR then re-randomized to either multiple dose low dose DCCR or high dose DCCR

Diazoxide choline high doseDRUG

A single dose high dose DCCR then re-randomized to either low or high multiple doses of DCCR

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: * Signed informed consent * Healthy adults * Fasting glucose ≤ 125 mg/dL and HbA1C ≤ 6.5 * Fasting triglyceride ≥150 mg/dL and ≤ 500 mg/dL Exclusion Criteria: * Known CAD, DM, uncontrolled HTN * Pregnancy or unable to complaint with the birth control method required

Outcomes

Primary Outcomes

Compare the single-dose and steady-state, fed and fasting PK profiles of two dose levels of diazoxide administered as DCCR

Time frame: 35 days

Secondary Outcomes

Assess the impact of dosing in the absence of food on the steady-state pharmacokinetic profiles of two dose levels of diazoxide administered orally as DCCR under fed conditions

Time frame: 35 days

Data from ClinicalTrials.gov

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