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

This study has been completed.
Sponsor:
Collaborator:
Cetero Research, San Antonio
Information provided by:
Essentialis, Inc.
ClinicalTrials.gov Identifier:
NCT00688857
First received: May 28, 2008
Last updated: November 4, 2010
Last verified: November 2010
  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:


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 October 29, 2014