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

Hypertriglyceridemia Clinical Trial

Official title:

A Randomized, Open-label, Multi-dose Crossover Study Assessing the Pharmacokinetic Profiles of Diazoxide Choline Coated Versus Uncoated Formulations in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00688857
• Other study ID #: PK008
• Status: Completed
• Phase: Phase 1
• First received: May 28, 2008
• Last updated: November 4, 2010
• Start date: May 2008
• Est. completion date: July 2008

Study information

• Verified date: November 2010
• Source: Essentialis, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertriglyceridemia

Intervention

Drug:
• Diazoxide choline
Diazoxide choline controlled-release coated tablets versus Diazoxide choline controlled-release uncoated tablets administered orally once daily
• Diazoxide choline
Diazoxide choline controlled-release uncoated tablets versus Diazoxide choline controlled-release coated tablets administered orally once daily

Locations

Country	Name	City	State
United States	PRACS Institute, Ltd. - Cetero Research	Fargo	North Dakota

Sponsors (2)

Lead Sponsor	Collaborator
Essentialis, Inc.	Cetero Research, San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the pharmacokinetic (PK) profiles of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers under fed conditions.		16 days	No
Secondary	Assess diazoxide choline pharmacokinetic (PK) parameters under fasted conditions		Study days 8 and 16	No
Secondary	Assess the safety and tolerability of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers.		Entire study	Yes