Pharmacokinetic Study of Diazoxide Choline in Hypertriglyeridemic Subjects

January 9, 2014 updated by: Essentialis, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

9

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Cetero

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Essentialis, Inc.

Collaborators

Cetero Research, San Antonio

Investigators

  • Principal Investigator: Alan K Copa, PharmD, Cetero Research - Fargo, ND

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (ACTUAL)

November 1, 2010

Study Completion (ACTUAL)

November 1, 2010

Study Registration Dates

First Submitted

September 28, 2010

First Submitted That Met QC Criteria

September 29, 2010

First Posted (ESTIMATE)

September 30, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

January 10, 2014

Last Update Submitted That Met QC Criteria

January 9, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PK015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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