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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.
 
ClinicalTrials.gov Identifier: NCT01211860
Recruitment Status : Completed
First Posted : September 30, 2010
Last Update Posted : January 10, 2014
Sponsor:
Collaborator:
Cetero Research, San Antonio
Information provided by (Responsible Party):
Essentialis, Inc.

Tracking Information
First Submitted Date  ICMJE September 28, 2010
First Posted Date  ICMJE September 30, 2010
Last Update Posted Date January 10, 2014
Study Start Date  ICMJE October 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 29, 2010)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2010)
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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetic Study of Diazoxide Choline in Hypertriglyeridemic Subjects
Official Title  ICMJE A Multiple-Dose Pharmacokinetic Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Subjects With Elevated Fasting Triglyceride Levels
Brief Summary Once a day oral administration with DCCR is the optimal dosing regimen
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Hypertriglyceridmia
Intervention  ICMJE Drug: Diazoxide Choline Controlled-Release Tablet
DCCR 290 mg once a day for 10 days
Study Arms  ICMJE Experimental: DCCR Treatment
DCCR Treatment 290 mg diazoxide choline
Intervention: Drug: Diazoxide Choline Controlled-Release Tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 9, 2014)
9
Original Estimated Enrollment  ICMJE
 (submitted: September 29, 2010)
10
Actual Study Completion Date  ICMJE November 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01211860
Other Study ID Numbers  ICMJE PK015
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Essentialis, Inc.
Study Sponsor  ICMJE Essentialis, Inc.
Collaborators  ICMJE Cetero Research, San Antonio
Investigators  ICMJE
Principal Investigator: Alan K Copa, PharmD Cetero Research - Fargo, ND
PRS Account Essentialis, Inc.
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP