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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Hypertriglyceridemia	Drug: Diazoxide choline	Phase 1

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	12 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Randomized, Open-label, Multi-dose Crossover Study Assessing the Pharmacokinetic Profiles of Diazoxide Choline Coated Versus Uncoated Formulations in Healthy Volunteers
Study Start Date :	May 2008
Actual Primary Completion Date :	June 2008
Actual Study Completion Date :	July 2008

Arms and Interventions

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Arm	Intervention/treatment
Experimental: 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).	Drug: Diazoxide choline; Diazoxide choline controlled-release coated tablets versus Diazoxide choline controlled-release uncoated tablets administered orally once daily
Experimental: 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)	Drug: Diazoxide choline; Diazoxide choline controlled-release uncoated tablets versus Diazoxide choline controlled-release coated tablets administered orally once daily

Outcome Measures

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Primary Outcome Measures :

1. 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 Outcome Measures :

1. Assess diazoxide choline pharmacokinetic (PK) parameters under fasted conditions [ Time Frame: Study days 8 and 16 ]
2. Assess the safety and tolerability of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers. [ Time Frame: Entire study ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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 ≤ 6.5.
• 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

Contacts and Locations

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Locations

United States, North Dakota
PRACS Institute, Ltd. - Cetero Research
Fargo, North Dakota, United States, 58104

Sponsors and Collaborators

Essentialis, Inc.

Cetero Research, San Antonio

Investigators

Principal Investigator:	Alan K. Copa, Pharm. D.	PRACS Institute, Ltd. - Cetero Research

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Neil M Cowen, PhD/Chief Scientific Officer, Essentialis, Inc
ClinicalTrials.gov Identifier:	NCT00688857 History of Changes
Other Study ID Numbers:	PK008
First Posted:	June 3, 2008
Last Update Posted:	November 8, 2010
Last Verified:	November 2010

Additional relevant MeSH terms:

Hypertriglyceridemia; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Choline; Diazoxide; Lipotropic Agents	Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Lipid Regulating Agents; Nootropic Agents; Antihypertensive Agents; Vasodilator Agents