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

Phase 1

Completed

• Conditions: Hypertriglyceridemia
• Interventions: Drug: Diazoxide choline

• Registration Number: NCT00688857
• Lead Sponsor: Essentialis, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-28
• Study First Submitted QC: 2008-05-29
• Primary Completion: 2008-06
• Study First Posted: 2008-06-03
• Study Completion: 2008-07
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-04
• Last Update Posted: 2010-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	Diazoxide choline	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).
B	Diazoxide choline	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)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

PRACS Institute, Ltd. - Cetero Research; 🇺🇸 Fargo, North Dakota, United States