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

May 28, 2008
November 4, 2010
May 2008
June 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00688857 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Open-label Pharmacokinetic Study of Diazoxide Choline Coated vs. Uncoated Formulations
A Randomized, Open-label, Multi-dose Crossover Study Assessing the Pharmacokinetic Profiles of Diazoxide Choline Coated Versus Uncoated Formulations in Healthy Volunteers

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertriglyceridemia
  • Drug: Diazoxide choline
    Diazoxide choline controlled-release coated tablets versus Diazoxide choline controlled-release uncoated tablets administered orally once daily
  • Drug: Diazoxide choline
    Diazoxide choline controlled-release uncoated tablets versus Diazoxide choline controlled-release coated tablets administered orally once daily
  • 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).
    Intervention: Drug: Diazoxide choline
  • 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)
    Intervention: Drug: Diazoxide choline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
July 2008
June 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00688857
PK008
No
Neil M Cowen, PhD/Chief Scientific Officer, Essentialis, Inc
Essentialis, Inc.
Cetero Research, San Antonio
Principal Investigator: Alan K. Copa, Pharm. D. PRACS Institute, Ltd. - Cetero Research
Essentialis, Inc.
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP