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

November 4, 2010 updated by: Essentialis, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • PRACS Institute, Ltd. - Cetero Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / 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
Drug: Diazoxide choline
Diazoxide choline controlled-release uncoated tablets versus Diazoxide choline controlled-release coated 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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
16 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Assess diazoxide choline pharmacokinetic (PK) parameters under fasted conditions
Time Frame: Study days 8 and 16
Study days 8 and 16
Assess the safety and tolerability of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers.
Time Frame: Entire study
Entire study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Essentialis, Inc.

Collaborators

Cetero Research, San Antonio

Investigators

  • Principal Investigator: Alan K. Copa, Pharm. D., PRACS Institute, Ltd. - Cetero Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (ACTUAL)

June 1, 2008

Study Completion (ACTUAL)

July 1, 2008

Study Registration Dates

First Submitted

May 28, 2008

First Submitted That Met QC Criteria

May 29, 2008

First Posted (ESTIMATE)

June 3, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

November 7, 2010

Last Update Submitted That Met QC Criteria

November 4, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PK008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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