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Pharmacokinetic Study of Diazoxide Choline in Hypertriglyeridemic Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01211860
Recruitment Status : Completed
First Posted : September 30, 2010
Last Update Posted : January 10, 2014
Cetero Research, San Antonio
Information provided by (Responsible Party):
Essentialis, Inc.

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

Condition or disease Intervention/treatment Phase
Hypertriglyceridmia Drug: Diazoxide Choline Controlled-Release Tablet Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Multiple-Dose Pharmacokinetic Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Subjects With Elevated Fasting Triglyceride Levels
Study Start Date : October 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: DCCR Treatment
DCCR Treatment 290 mg diazoxide choline
Drug: Diazoxide Choline Controlled-Release Tablet
DCCR 290 mg once a day for 10 days

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01211860

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United States, North Dakota
Fargo, North Dakota, United States, 58104
Sponsors and Collaborators
Essentialis, Inc.
Cetero Research, San Antonio
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Principal Investigator: Alan K Copa, PharmD Cetero Research - Fargo, ND
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Responsible Party: Essentialis, Inc. Identifier: NCT01211860    
Other Study ID Numbers: PK015
First Posted: September 30, 2010    Key Record Dates
Last Update Posted: January 10, 2014
Last Verified: January 2014
Keywords provided by Essentialis, Inc.:
Diazoxide Chonline Controlled-Release Tablet = DCCR
Additional relevant MeSH terms:
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Lipotropic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents
Antihypertensive Agents
Vasodilator Agents