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

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ClinicalTrials.gov Identifier: NCT00688857
Recruitment Status : Completed
First Posted : June 3, 2008
Last Update Posted : November 7, 2010
Sponsor:
Collaborator:
Cetero Research, San Antonio
Information provided by:
Essentialis, Inc.

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

Resource links provided by the National Library of Medicine


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, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00688857


Locations
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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
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Principal Investigator: Alan K. Copa, Pharm. D. PRACS Institute, Ltd. - Cetero Research
More Information
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Responsible Party: Neil M Cowen, PhD/Chief Scientific Officer, Essentialis, Inc
ClinicalTrials.gov Identifier: NCT00688857    
Other Study ID Numbers: PK008
First Posted: June 3, 2008    Key Record Dates
Last Update Posted: November 7, 2010
Last Verified: November 2010
Additional relevant MeSH terms:
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Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Diazoxide
Choline
Lipotropic Agents
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents
Antihypertensive Agents
Vasodilator Agents