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Pharmacokinetic Study of Diazoxide Choline in Hypertriglyeridemic Subjects

This study has been completed.
Sponsor:
Collaborator:
Cetero Research, San Antonio
Information provided by (Responsible Party):
Essentialis, Inc.
ClinicalTrials.gov Identifier:
NCT01211860
First received: September 28, 2010
Last updated: January 9, 2014
Last verified: January 2014
  Purpose
Once a day oral administration with DCCR is the optimal dosing regimen

Condition Intervention Phase
Hypertriglyceridmia
Drug: Diazoxide Choline Controlled-Release Tablet
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Multiple-Dose Pharmacokinetic Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Subjects With Elevated Fasting Triglyceride Levels

Resource links provided by NLM:


Further study details as provided by Essentialis, Inc.:

Primary Outcome 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 Outcome 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)


Enrollment: 9
Study Start Date: October 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DCCR Treatment
DCCR Treatment 290 mg diazoxide choline
Drug: Diazoxide Choline Controlled-Release Tablet
DCCR 290 mg once a day for 10 days

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.

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01211860

Locations
United States, North Dakota
Cetero
Fargo, North Dakota, United States, 58104
Sponsors and Collaborators
Essentialis, Inc.
Cetero Research, San Antonio
Investigators
Principal Investigator: Alan K Copa, PharmD Cetero Research - Fargo, ND
  More Information

Responsible Party: Essentialis, Inc.
ClinicalTrials.gov Identifier: NCT01211860     History of Changes
Other Study ID Numbers: PK015
Study First Received: September 28, 2010
Last Updated: January 9, 2014

Keywords provided by Essentialis, Inc.:
DCCR
Diazoxide Chonline Controlled-Release Tablet = DCCR
Hypertriglyceridemia
Triglycerides
Pharmacokinetics

Additional relevant MeSH terms:
Diazoxide
Choline
Antihypertensive Agents
Vasodilator Agents
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents

ClinicalTrials.gov processed this record on March 24, 2017