Pharmacokinetic Study of Diazoxide Choline in Hypertriglyeridemic Subjects

Overview

Once a day oral administration with DCCR is the optimal dosing regimen

Full Title of Study: “A Multiple-Dose Pharmacokinetic Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Subjects With Elevated Fasting Triglyceride Levels”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2010

Detailed Description

POPULATION The population will consist of generally healthy subjects with elevated fasting triglyceride levels in the range of ≥ 150 mg/dL and ≤ 1500 mg/dL at the Screening Visit. Number of Subjects A total of 10 subjects will be enrolled in the study at 1 site in the USA.

Interventions

  • Drug: Diazoxide Choline Controlled-Release Tablet
    • DCCR 290 mg once a day for 10 days

Arms, Groups and Cohorts

  • Experimental: DCCR Treatment
    • DCCR Treatment 290 mg diazoxide choline

Clinical Trial Outcome Measures

Primary Measures

  • Steady-state Pharmacokinetic profile of DCCR
    • Time Frame: 10 days
    • Mean concentration-time profile for diazoxide Steady-state pharmacokinetic parameters of diazoxide (Cmax(ss), AUC0-inf(ss), and CL/F) Terminal elimination half-life (t½) of diazoxide

Secondary Measures

  • Concentration-Time profile of major metabolite
    • Time Frame: 10 days
    • Steady-state pharmacokinetic parameters (Cmax(ss) and AUC0-inf(ss)) of the major metabolite of diazoxide Terminal elimination half-life (t½) of the major metabolite of diazoxide Metabolite-to-parent ratios at steady-state in terms of Cmax(ss) and AUC0-inf(ss)

Participating in This Clinical Trial

Inclusion Criteria

Basic requirements 1. Healthy male and female subjects 18 to 75 years of age, inclusive at the time of dosing 2. Body mass index (BMI) between 22 and 35 kg/m2 Specific laboratory test results 3. Fasting triglyceride ≥ 150 mg/dL and ≤ 1500 mg/dL 4. Fasting glucose ≤ 110 mg/dL 5. HbA1c ≤ 6.0 % Exclusion Criteria:

Medications: recent, current, anticipated 1. Thyroid hormones or preparations within 1 month prior to Screening Visit (except in subjects on stable dose of replacement therapy for at least 1 month) 2. Thiazide diuretics within 2 weeks prior to Screening Visit History of allergic reaction or significant intolerance to: 3. Diazoxide 4. Thiazides 5. Sulfonamides Lifestyle changes 6. Subjects intending to change exercise habits, and/or quit smoking Specific diagnoses, medical conditions and history 7. Known type I or III hyperlipidemia 8. Known type 1 DM 9. Known type 2 DM 10. Any other clinically significant endocrine, cardiovascular, pulmonary, neurological, psychiatric, hepatic, gastrointestinal, hematological, renal, or dermatological disease interfering with the assessments of the investigational drug, according to the Investigator Specific laboratory test results 11. Any relevant biochemical abnormality interfering with the assessments of the investigational drug

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
    • Sponsor
  • Overall Official(s)
    • Alan K Copa, PharmD, Principal Investigator, Cetero Research – Fargo, ND

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