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Open-Label, Single- and Multiple-Dose Pharmacokinetic Study of Diazoxide Choline

Primary Purpose

Hypertriglyceridemia

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Diazoxide choline
Diazoxide choline high dose
Sponsored by
Essentialis, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertriglyceridemia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Signed informed consent
  • Healthy adults
  • Fasting glucose ≤ 125 mg/dL and HbA1C ≤ 6.5
  • Fasting triglyceride ≥150 mg/dL and ≤ 500 mg/dL

Exclusion Criteria:

  • Known CAD, DM, uncontrolled HTN
  • Pregnancy or unable to complaint with the birth control method required

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Sequence 1

    Sequence 2

    Arm Description

    Single dose of low dose DCCR followed by a 14 day washout, then re-randomized to either low or high multiple dose DCCR

    Single dose of high dose DCCR followed by a 14 day washout, then re-randomized to either low or high multiple dose DCCR

    Outcomes

    Primary Outcome Measures

    Compare the single-dose and steady-state, fed and fasting PK profiles of two dose levels of diazoxide administered as DCCR

    Secondary Outcome Measures

    Assess the impact of dosing in the absence of food on the steady-state pharmacokinetic profiles of two dose levels of diazoxide administered orally as DCCR under fed conditions

    Full Information

    First Posted
    May 12, 2009
    Last Updated
    August 30, 2016
    Sponsor
    Essentialis, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00901823
    Brief Title
    Open-Label, Single- and Multiple-Dose Pharmacokinetic Study of Diazoxide Choline
    Official Title
    A Randomized, Open-Label, Single- and Multiple-Dose, Four-Way Parallel Study Comparing the Fed and Fasted Pharmacokinetics of Two Dose Levels of Diazoxide Choline Controlled-Release Tablet (DCCR) in Healthy VolunteersVOLUNTEERS
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Did not support the planned development of DCCR in the new indication
    Study Start Date
    March 2011 (undefined)
    Primary Completion Date
    March 2011 (Anticipated)
    Study Completion Date
    March 2011 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Essentialis, Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is a single-center, randomized, open-label, single- and multiple-dose, five-treatment, two-period, four-way parallel study comparing the pharmacokinetics (PK) of Diazoxide Choline Controlled-Release Tablet (DCCR) administered orally under fed and fasting conditions at two dose levels.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertriglyceridemia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Sequence 1
    Arm Type
    Experimental
    Arm Description
    Single dose of low dose DCCR followed by a 14 day washout, then re-randomized to either low or high multiple dose DCCR
    Arm Title
    Sequence 2
    Arm Type
    Experimental
    Arm Description
    Single dose of high dose DCCR followed by a 14 day washout, then re-randomized to either low or high multiple dose DCCR
    Intervention Type
    Drug
    Intervention Name(s)
    Diazoxide choline
    Intervention Description
    A single dose low dose DCCR then re-randomized to either multiple dose low dose DCCR or high dose DCCR
    Intervention Type
    Drug
    Intervention Name(s)
    Diazoxide choline high dose
    Intervention Description
    A single dose high dose DCCR then re-randomized to either low or high multiple doses of DCCR
    Primary Outcome Measure Information:
    Title
    Compare the single-dose and steady-state, fed and fasting PK profiles of two dose levels of diazoxide administered as DCCR
    Time Frame
    35 days
    Secondary Outcome Measure Information:
    Title
    Assess the impact of dosing in the absence of food on the steady-state pharmacokinetic profiles of two dose levels of diazoxide administered orally as DCCR under fed conditions
    Time Frame
    35 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Signed informed consent Healthy adults Fasting glucose ≤ 125 mg/dL and HbA1C ≤ 6.5 Fasting triglyceride ≥150 mg/dL and ≤ 500 mg/dL Exclusion Criteria: Known CAD, DM, uncontrolled HTN Pregnancy or unable to complaint with the birth control method required

    12. IPD Sharing Statement

    Learn more about this trial

    Open-Label, Single- and Multiple-Dose Pharmacokinetic Study of Diazoxide Choline

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