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

NCT00688857 | Completed Phase 1

• 1 other identifier: PK008
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertriglyceridemia

Outcome Measures

Primary Outcomes (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 Outcomes (2)

• Assess diazoxide choline pharmacokinetic (PK) parameters under fasted conditions

  Study days 8 and 16

• Assess the safety and tolerability of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers.

  Entire study

Study Arms (2)

A

EXPERIMENTAL

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

B

EXPERIMENTAL

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

Interventions

Diazoxide choline DRUG

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

A

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Essentialis, Inc.: lead
• Cetero Research, San Antonio: collaborator

Study Sites (1)

PRACS Institute, Ltd. - Cetero Research

Fargo, North Dakota, 58104, United States

Location

MeSH Terms

Conditions

Hypertriglyceridemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Alan K. Copa, Pharm. D.

  PRACS Institute, Ltd. - Cetero Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 28, 2008
• First Posted: June 3, 2008
• Study Start: May 1, 2008
• Primary Completion: June 1, 2008
• Study Completion: July 1, 2008
• Last Updated: November 8, 2010

Record last verified: 2010-11

Locations

US (1)