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

Sponsor
Essentialis, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00688857
Collaborator
Cetero Research, San Antonio (Other)
12
Enrollment
1
Location
2
Arms
2
Duration (Months)
6
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: Diazoxide choline
  • Drug: Diazoxide choline
 Phase 1

Study Design

Study Type:
Interventional
Anticipated 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 1, 2008
Actual Primary Completion Date :
Jun 1, 2008
Actual Study Completion Date :
Jul 1, 2008

Arms and Interventions

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

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. [16 days]

Secondary Outcome Measures

  1. Assess diazoxide choline pharmacokinetic (PK) parameters under fasted conditions [Study days 8 and 16]

  2. Assess the safety and tolerability of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers. [Entire study]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00688857
Other Study ID Numbers:
  • PK008
First Posted:
Jun 3, 2008
Last Update Posted:
Nov 7, 2010
Last Verified:
Nov 1, 2010
Additional relevant MeSH terms:
Hypertriglyceridemia
Diazoxide
Choline

Study Results

No Results Posted as of Nov 7, 2010