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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2008

Interventions

  • 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

Arms, Groups and Cohorts

  • 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).
  • 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)

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Essentialis, Inc.
  • Collaborator
    • Cetero Research, San Antonio
  • Provider of Information About this Clinical Study
    • Neil M Cowen, PhD/Chief Scientific Officer, Essentialis, Inc
  • Overall Official(s)
    • Alan K. Copa, Pharm. D., Principal Investigator, PRACS Institute, Ltd. – Cetero Research

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