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

Purpose

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	Intervention	Phase
Hypertriglyceridemia	Drug: Diazoxide choline	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Triglycerides

Drug Information available for: Choline chloride Choline bitartrate Diazoxide

Genetic and Rare Diseases Information Center resources: Sphingolipidosis

U.S. FDA Resources

Further study details as provided by Essentialis, Inc.:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assess diazoxide choline pharmacokinetic (PK) parameters under fasted conditions [ Time Frame: Study days 8 and 16 ] [ Designated as safety issue: No ]
Assess the safety and tolerability of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers. [ Time Frame: Entire study ] [ Designated as safety issue: Yes ]


Estimated Enrollment:	12
Study Start Date:	May 2008
Study Completion Date:	July 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00688857

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

No publications provided


Responsible Party:	Neil M Cowen, PhD/Chief Scientific Officer, Essentialis, Inc
ClinicalTrials.gov Identifier:	NCT00688857 History of Changes
Other Study ID Numbers:	PK008
Study First Received:	May 28, 2008
Last Updated:	November 4, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Hypertriglyceridemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Choline Diazoxide Antihypertensive Agents Antimetabolites Cardiovascular Agents	Central Nervous System Agents Gastrointestinal Agents Hypolipidemic Agents Lipid Regulating Agents Lipotropic Agents Molecular Mechanisms of Pharmacological Action Nootropic Agents Pharmacologic Actions Therapeutic Uses Vasodilator Agents

ClinicalTrials.gov processed this record on March 03, 2015