Back to resultsOpen-label Pharmacokinetic Study of Diazoxide Choline Coated vs. Uncoated Formulations
Primary Purpose
Hypertriglyceridemia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Diazoxide choline
Diazoxide choline
Sponsored by
About this trial
This is an interventional treatment trial for Hypertriglyceridemia
Eligibility 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
Sites / Locations
- PRACS Institute, Ltd. - Cetero Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
A
B
Arm Description
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).
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)
Outcomes
Primary Outcome Measures
Compare the pharmacokinetic (PK) profiles of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers under fed conditions.
Secondary Outcome Measures
Assess diazoxide choline pharmacokinetic (PK) parameters under fasted conditions
Assess the safety and tolerability of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers.
Full Information
NCT ID
NCT00688857
First Posted
May 28, 2008
Last Updated
November 4, 2010
Sponsor
Essentialis, Inc.
Collaborators
Cetero Research, San Antonio
1. Study Identification
Unique Protocol Identification Number
NCT00688857
Brief Title
Open-label Pharmacokinetic Study of Diazoxide Choline Coated vs. Uncoated Formulations
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 Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Essentialis, Inc.
Collaborators
Cetero Research, San Antonio
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertriglyceridemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
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).
Arm Title
B
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Diazoxide choline
Intervention Description
Diazoxide choline controlled-release coated tablets versus Diazoxide choline controlled-release uncoated tablets administered orally once daily
Intervention Type
Drug
Intervention Name(s)
Diazoxide choline
Intervention Description
Diazoxide choline controlled-release uncoated tablets versus Diazoxide choline controlled-release coated tablets administered orally once daily
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Assess diazoxide choline pharmacokinetic (PK) parameters under fasted conditions
Time Frame
Study days 8 and 16
Title
Assess the safety and tolerability of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers.
Time Frame
Entire study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan K. Copa, Pharm. D.
Organizational Affiliation
PRACS Institute, Ltd. - Cetero Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
PRACS Institute, Ltd. - Cetero Research
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Open-label Pharmacokinetic Study of Diazoxide Choline Coated vs. Uncoated Formulations
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